WHO Scoring of Ayurveda Symptoms
WHO Scoring of Ayurveda Symptoms
WHO Scoring of Ayurveda Symptoms
PRINCIPAL INVESTIGATOR
PROF. M. S. BAGHEL
INVESTIGATOR
DR. RAJAGOPALA S
2011
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PREFACE
Traditional medicine in general is the sum total of the knowledge, skills and
practices based on the theories, beliefs and experiences indigenous to different
cultures, whether explicable or not, used in the maintenance of health, as well as
in the prevention, diagnosis, improvement or treatment of physical and mental
illnesses [3]. The theories and concepts of prevention, diagnosis, improvement and
treatment of illness in traditional medicine historically rely on a holistic approach
towards the sick individual, and disturbances are treated on the physical,
emotional, mental, spiritual and environmental levels simultaneously. As a result,
most systems of traditional medicine may use herbal medicines or traditional
procedure-based therapies along with certain behavioural rules promoting healthy
diets and habits. Holism is a key element of all systems of traditional medicine.
Ayurveda, the indigenous medicine to India involves all the above said facts. In
addition to the physical and mental health component, it adds the spiritual and
social health also in to account and give a complete definition to health which of
course a unique to itself.
Present day Ayurvedic researches are failing in this aspect as they are unable to
disseminate the knowledge gained from the exercises. Ayurvedic research of the
last 50 years has not changed the practice of Ayurveda neither text books were
enriched with these new researches. Prof. RH Sigh has made the same observation
“Ongoing research is proceeding in such a way that it is of more value to modern
medicine than Ayurved. It doesn’t strengthen Ayurveda and Ayurvedic practice,
Ayurvedic research outcomes have not trickled down to professional use; neither do
they benefit Ayurveda students or practitioners” [1]
The drug researches conducted in the field of Ayurveda for the last six decades
have not enriched the Ayurvedic understanding or Ayurvedic concepts though
these researches have created a better understanding of Ayurveda by the modern
medical fraternity. The researches on herbal pharmacology have led confirmation of
few concepts like reverse pharmacology, use of whole crude drugs in place of
isolation of fractions for clinical trails etc. These leads have changed the mindset of
researchers in herbal medicine. In last decade, too much of interest has been
generated in medical world regarding Ayurveda and other traditional medicines.
However, these all efforts have led to the enrichment of the knowledge of the
modern medicine and inclusion of some Ayurvedic herbs in to the Modern Materia
Medica (IP/BP).
During the last couple of decades, knowledge and use of Ayurveda medicine has
expanded globally and has gained popularity. It has not only continued to be used
for primary health care in India, but has also been used in countries where
conventional medicine is predominant. With this expansion of the use of Ayurveda
medicine worldwide, safety and efficacy as well as quality control of medicines and
procedure-based therapies have become important concerns for both health
authorities and the public. There are no international standards and appropriate
methods for evaluating traditional medicine. The challenge now is to ensure that
traditional medicine is used properly and to determine how research and
evaluation of traditional medicine should be carried out.
The quantity and quality of the safety and efficacy data on traditional medicine are
far from sufficient to meet the criteria needed to support its use worldwide. The
reasons for the lack of research data are due not only to health care policies, but
also to a lack of adequate or accepted research methodology for evaluating
traditional medicine. It should also be noted that there are heaps of published and
unpublished data on research in traditional medicine, but further research in
safety and efficacy should be promoted, and the quality of the research should be
improved. The methodologies for research and evaluation of traditional medicine
should guarantee the safety and efficacy of herbal medicines and traditional
procedure- based therapies and also they should not become obstacles to the
application and development of traditional medicine following its holistic principles.
Thus, the efficacy of traditional medicine has to be evaluated in an integrated
manner.
Since last few years it has been felt that there is a great need for a separate
research methodology for Ayurveda particularly for the clinical research. WHO has
made an attempt in this regard for Traditional medicines in 2000 [3] (WHO/TRM
guidelines). The guidelines focus on the current major debates on safety and
efficacy of traditional medicine, and are intended to raise and answer some
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challenging questions concerning the evidence base. The guidelines present some
national regulations for the evaluation of herbal medicine, and also recommend
new approaches for carrying out clinical research. The quality of life (QOL) manual
was developed by the WHO Program on Mental Health, and may also be used to
evaluate the results of clinical research in traditional medicine [3]. This document
has strongly recommended the exhaustive training of man power of Ayurvedic
institutions for research methodology. But the system has failed in production of
true Ayurvedic researchers owing to the facts narrated above i.e. lack of a clear
understanding of modern research methodology as well as its non-suitability for
Ayurveda and other Traditional systems of Medicines. Because of this various
researchers in the country started to feel that conventional clinical trial regimen is
not fit for Ayurveda. Dr. Ram Manohar [4] has opined that Ayurveda is based on
5000 years of clinical practice hence in place of conventional EBM (Evidence Based
Medicine) clinical trials, practice based clinical trials should be organized for
Ayurveda.
This is my strong view that the regime of EBM clinical trial with its evidence based
hierarchy is not fit for Ayurvedic clinical trials, limitation of EBM clinical trial
regimens limit the use of Prakriti, Dosha Anubandha-Anubandhyatwa, Arambhaka
and Anugami Dosha Vikalpa, Swanidana Prakopa Avaranajanya Prakopa, Prakriti
Sava Samaveta – Vikritivishamasaveta, Amavastha, Pakvavastha, etc. which leads
to variation of dose, dosage, form, Aushadhasevana kala, Anupana - sahapanaa,
Pathya-apathya, therapeutics like Panchakarma and Kriyakalpa procedures to be
adopted etc., hence if desired results of actual clinical practices are to be recorded,
the protocols should be prepared on these lines supported by EBM suitable for the
purpose. Ayurveda requires research in the areas of Ayurvedic diagnostic principles
taking into consideration of Dosha, Dushya, Agni, Ama, etc. units of Samprapti , so
that the Ayurvedic diagnosis can be made more pinpointed leading to more effective
treatment strategies. Ayurveda is a pure science based on strict logical explanation,
which are called Darshana. In last 2000 years, very less conceptual development in
Ayurveda is evident however whatever has been added is less explained or obscure.
Due to socio-political reasons, redaction (Pratisamskara) of Ayurvedic Samhitas
could not be done in last 2000 years which was mandatory every 1000 years. This
means that the present Samhitas are lagging behind to present the knowledge.
Many of the diagnostic tools have been missed in between and new principles like
Avarana added later on are remained unexplained.
4
Dr. Nandini Kumar [5] has also opined that there is need to stem the misuse of
Indian traditional knowledge and there is dire need to gear up ourselves to show
the science carried out in Ayurvedic way but also use modern science to produce
interpretative evidence. Though ICMR advocates that protocols for Ayurvedic
researches had been prepared in consultation with ayurvedists however it does not
fulfill the actual need of strengthening Ayurveda.
Dr. Valiathan and his team, Dr. Ashok Vaidya and his team have started ‘Science
Initiatives in Ayurveda’, in order to explore Ayurvedic fundamentals like Prakriti in
the parlance of Genomics etc., for the welfare of the Humanity which is most
welcome. Genetic and epigenetic responses are being understood by some
scientists in the light of Prakriti, Oja, Bala and Rasayana. This is the beginning of
the study and will not go fat, if all the fundamental principles of Ayurveda are not
taken into consideration while initiating these projects.
Ayurveda looks like a mesmerizing ‘sleeping beauty’ for the modern medical
scientists, this illusion is due to the failures of modern medicine in curing
metabolic disorders, autoimmune disorders and cancer etc., however Ayurveda has
much more to offer than Oja, Bala and Prakriti. There are many fundamental
principles in Ayurveda which can be helpful in understanding the maladies in
modern medicine. But more than these there are many more fundamental
principles described in Ayurveda in brief and they are still not understood properly
by ayurvedists themselves. So while talking to holistic approach of Ayurveda, the
principles of Ayurveda should be applied in toto.
Looking into all these facts, years long effort on developing a pure ayurvedic patient
screening proforma was prepared, and with the help of learned Ayurveda scientists
/ educationists it was revised, later a proposal was sent to WHO Country Office
India for conduct of a national workshop on this topic, it was with the timely
support received from WHO, we could organize a national workshop in November
2009, srotas wise symptoms were graded for clinical evaluation, considering some
major diseases of particular srotas also into account. But these are in Sanskrit
language and solely can be understood by a person who is well versed in Ayurveda
terminologies and concepts. The finalized drafts were again scrutinized in an expert
meet held in March 2011, and a draft document is prepared, now it is in your
hands. This documents are again not final, it requires field trails, the lacunae are
to be identified and possibly after a couple of years of field trails we could be in a
position to call it standard.
The purpose of the guidelines are - These guidelines have been developed to
improve the situation described above, and to promote the proper use and
development of Ayurveda particularly to have a standard clinical research pattern
all over. It also aim to develop specific guidelines for clinical research for Indian
system of medicines i.e. Ayurveda, and also to develop a specific assessment
criteria based on disease and QOL parameters as explained by Charaka viz.
Agnibala, Dehabala, Chetasa Bala. The second aim is to prepare standard scoring
pattern for classical Ayurvedic symptom / signs to give more objectivity to
subjective sign and symptoms so that uniformity and reproducibility of data is
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made easy, and to improve the quality and value of research in Ayurveda and this
in turn will provide appropriate evaluation methods to facilitate the development of
regulation mechanism in Ayurveda research.
It is my strong believe that the outcome of this format will positively contribute for
better understanding of the pathogenesis concepts of Ayurveda in terms of Dosha,
Dhatu, Srotas, Guna, etc. and finally will help in strengthening Ayurveda. Now it is
high time that we should take cognizance that whether the use of conventional
research methodology for Ayurveda research or to use a separate methodology
developed incorporating leads from conventional methods and Ayurvedic principles
in a symbiotic manner. I wish this effort will be a starting point in this direction
and in the days ahead, we will be in a position to have a strong base of research
methodology and clinical research in Ayurveda.
- Prof. MS Baghel
Director, IPGT&RA
Principal Investigator
Reference:
1. Singh RH, Exploring issues in the developemt of Ayurvedic research methodology,
journal of ayurveadn integrative medicine, Vo 1, issue 2, April 2010, PP 91 – 95
2. Aiman Ranita, Indian indigenous drugs – retrospect – prospect,
Ind.J.Pharmac.,11(1)i-12 (1979).
3. WHO/TRM Guidelines, 2000 Downloaded from
www.sho.int/entity/hiv/amds/WHOTCM2005.1_OMS.pdf on 24.06.2006, New
Delhi.
4. Ram Manohar P, Evidence base for Traditional Medicine through practice based
research, International Conclave on Traditional Medicine, 16 -17, Nov 2006, New
Delhi.
5. Dr. Nandini K Kumar, personal communication dated 01Nov 2009
6. Dr. Valiathan, Ayurvedic Biology
7. Journal experimental biology, 1968-1975.
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Acknowledgements:
At the outset of accomplishment of this mammoth task, we would like to convey our heartfelt
thanks to the WHO Country Office for India, New Delhi for the sanction, support and providing the
technical support whenever required. We pay our sincere thanks to Dr. D. C. Katoch, Ex. National
Consultant (Traditional Medicines & Homeopathy), WHO Country Office for India, New Delhi for his
keen interest in the task and also for providing necessary technical inputs, it was his guidelines which
made this project in the present shape.
We also remember with great respect those personalities who inspired, initiated and helped in
successful completion of this task, the first being Prof. M. S. Baghel, Director, IPGT&RA, Gujarat
Ayurved University, Jamnagar and also the chief investigator of this project, without whose
guidance, and support it would not have been possible to complete this work. It was his thoughts
materialized in the form of this work. He is also acknowledged for providing the Clinical Research
Format which he developed with his vast field experience for the general cause of ayurvedic clinical
research.
We also would like to acknowledge with respect the experts participated in the national workshop
conducted in November 2009 and gave their valuable inputs, Prof. R.H. Singh, Dr. Nandini Kumar,
Dr. Dilip Gadgil, Dr. M.M. Padhi, and Dr. Vasanth Patil requires a special mention. We are equally
thankful to the experts who have participated in the expert meet held in March 2011 viz. Prof. C. P.
Shukla, Prof. Gurdip Singh, Dr. S. H. Acharya, Prof. GS Acharya and Dr. Rammanohar who have
contributed by way of scrutinizing the text prepared. Teaching faculty members of IPGT&RA also
deserves a special mention in this acknowledgement for their timely help, technical inputs and pains
and efforts taken to make the project complete. We also remember with gratitude and pay our
sincere thanks to all those who have responded to our mails and letters and provided the technical
inputs which were helpful in preparation of this manuscript. Without the help of our Post Graduate
and Ph. D. Scholars it would not have been possible to reach to this stage in the project, their help
and contribution received at every stage of the work is acknowledged with thanks.
Secretarial assistances received from the different offices of IPGT&RA are also acknowledged at this
juncture. Finally we pay our sincere appreciation and thanks to all those individuals who have helped
in this project directly or indirectly to make it complete.
Dr. Rajagopala S
Project Co-investigator
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Index
Sl. No. Title Page No.
1 A Guideline to User’s Of This Manual
1.1 Example 1: Tamaka Shvasa
1.2 Example 2: Amavata
1.3 Example 3: Amlapitta
1.4 Agni Bala Index
2 Manual Part 1:
2.1 General Screening Proforma – CRF 1
2.2 Assessment of Prakriti
2.3 Assessment of Sharirika Prakruti Features Of Somatic
Constitution (Self Answering Questionnaire)
3 Manual Part 2
3.1 Gradation Of Symptoms: Pranavaha Srotas
3.2 Gradation of Symptoms: Udakavaha Srotas
3.3 Gradation of Symptoms: Annavaha Srotas
3.4 Grading of Amlapitta Symptoms
3.5 Gradation of Symptoms: Rasavaha Srotas
3.6 Gradation Of Symptoms: Raktavaha Srotas
3.7 Gradation of Symptoms of Eka Kustha – Psoriasis
3.8 Gradation of Symptoms: Mamsavaha Srotas
3.9 Gradation of Symptoms: Medovaha Srotas
3.10 Criteria for Assessment of Results For Madhumeha
3.11 Criteria for Assessment of Sthaulya
3.12 Gradation Of Symptoms: Asthivaha Srotas
3.13 Scoring Pattern For Osteoporosis
3.14 Gradation Of Symptoms: Majjavaha Srotas
3.15 Gradation Of Symptoms: Shukravaha Srotas
3.16 Gradation Of Symptoms: Mutravaha Srotas
3.17 Gradation Of Symptoms: Purishavaha Srotas
3.18 Gradation Of Symptoms: Swedavaha Srotas
3.19 Gradation Of Symptoms: Artavavaha Srotas
3.20 Manasa pariksha bhava (mental factor examination)
3.21 Manasa vibhrama pariksha
3.22 Some general symptoms
3.23 Signs and symptoms of AMA in general
3.24 Agnibala assessment
3.25 Dehabala assessment
3.26 Satvabala assessment
4 Glossary of Ayurvedic terms
5 Brief report of expert meet
6 Brief technical report of national workshop
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A GUIDELINE TO USER’S OF THIS MANUAL
• This clinical research format is meant for clinical research personnel who have prior
exposure to Ayurveda and Ayurvedic terminologies.
• This guideline is presented in three parts, first part deals with general instructions and
some examples for calculation of overall effect of therapy and Agnibala of the patients.
The second part in CRF – 1 which is for patient data recording, a preliminary screening
Proforma and the third part comprises of the gradation of symptoms. The gradation of
symptoms are presented in two forms, viz. one general symptoms seen in Srotas and
second is with symptoms specific diseases corresponding to the Srotas.
• CRF – 1 [Clinical Research Format – 1] comprises of assessment of Roga bala Deha
bala Agni bala and Satva bala of the patients as per the description given in Charaka
Samhita (Ref. Charaka Samhita, Vimana Sthana Chapter 4).
• The specific disease related symptom presentation should be appended with CRF – 1 i.e.
questions specific to the diseases according to the Roga and its variants such as Dosha
etc.
• Roga Bala Pariksha is done in three headings viz. Kapha Varga, Pitta Varga and Vata
Varga. In each category it is further divided into Dosha Pariksha, Srotas involvement and
other systemic examination findings and supportive modern investigations if any
pertaining to these Srotases.
• Systemic examinations of the modern clinical methods are included within the Srotases
concerned, and so no separate systemic examination may be required.
• For each symptom of the Srotas involved suitable scoring pattern or gradation to be
adopted.
• Some symptoms are seen repeated in many places, such symptoms are kept under
‘General symptomatology’ heading; they are to be applied in required Srotas and diseases
by the research scholar. Similarly more one type of gradation may be applied to one
symptom from different angle of evaluation; they are also kept side by side in the text.
• Agni Bala: A Agni Bala Index (ABI) calculation is given in this which is basically for
Snehapana. But the same may be used in other research works too, wherever Agnibala is
in question.
• With regards to Quality of Life (QOL) parameters, the established WHO’s QOL
parameters may be used in research works of Ayurveda.
• Wherever parameter is expressed in terms of numbers i.e. Numerical Data / Quantitative
Data (e.g. Mutra Madhurya or glycosurea is expressed in terms of percentage; body
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temperature in terms of degree centigrade or Fahrenheit), there is no need of any
gradation, the number itself is to be considered as grade; increase or decrease (as the case
may be) in the number is improvement in the grade of the symptom.
• A ‘Prakriti Self Analysis Questionnaire’ and ‘Prakriti Analysis Proforma’ (to be
performed by the observer) are given as Annexure, which may be used by research
scholars to assess the Doshic Prakriti of the patients.
• With regards to Good Clinical Practice (GCP), the guidelines issued by Dept. of AYUSH
for Ayurveda, Unani, Siddha system of medicines is to be followed.
• The ICMR “Ethical Guidelines for Biomedical Research in Human Participants” also
to be followed in all clinical research projects wherever applicable.
• The WHO guidelines for TRM give basic information regarding conduct of clinical
research in traditional systems of medicines; the applicable parts may be utilized in
Ayurveda clinical research too.
• Ethical clearance from the Institutional Ethics Committee or appropriate body is
mandatory for all clinical research projects.
• The plan of research should include specific inclusion & exclusion criteria, good and
appropriate (blinding – single/double/triple, black box, pilot study, single case study etc.)
study design and the outcome should be evaluated by applying suitable statistical
methods. The sample size to be calculated by applying appropriate sample size
calculation method as put forth by WHO, ICMR and such other research agencies. For
evaluation of the outcome specifically for the Srotas the given gradation of symptoms
may be used.
• Research personnel are advised to note that where ever short forms are used, it is to be
clearly defined.
• A unique arbitrary scoring method has been developed for evaluation of total outcome of
the clinical research. This arbitrary scoring method may be adapted to each clinical
research where in the total score would be 100; it is divided in four sectors relating to
Rogabala, Dehabala, Agnibala and Chetas / Satvabala, by giving due consideration and
weightage to Rogabala. The quality of life outcomes are measured using Dehabala,
Agnibala and Chetas / Satvabala. The disease in which Roga is strong in comparison to
other, then Rogabala will get maximum weightage, disease in which Satvabala /
Chetasbala is weak and needs maximum improvement, there it will get more weightage
in this scoring method, however the maximum being 100.
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• The research team should decide the arbitrary scoring division in the beginning itself
before starting the clinical research work, with a suitable hypothesis so that at the end
outcome may be measured.
• All the accepted grading systems of modern medicine to be adopted as such without any
alterations in appropriate symptoms or signs.
• The technical words of Ayurveda are given in Sanskrit language in the whole of the text
and glossary (meaning near to the Sanskrit word) for the same is also provided.
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Total 100 score has been divided in following- Rogabala, Dehabala, Agnibala and
Chetasabala as -
Rogabala 60
Agnibala 20
Dehabala 10
Chetasabala 10
AGNIBALA (20)
It has been further divided into as follows;
Abhyavaharanashakti 6 Jaranashakti 6
Ruchi hi Aaaharakale 4 Vata Mutra Purisha Retasam Mukti 4
DEHABALA (10)
It has been further divided into as follows;
Balavriddhi 4 Swara Varna Yoga 4 Sharira Upachaya 2
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SATVABALA (10)
It has been further divided as follows;
Nidra Labhoyathakalam 4
Sukhena Cha Pratibodhanam 2
Vaikarikanam Cha Swapnanam Adarshanam 2
Mano Buddhi Indriya Avyappatti 2
To establish the results statistically each sign & symptom may be given a specific score:
1) Frequency of Shvasa Vega:
0 - No attack during last 1 month
1 - Frequency of attack once in a month
2 - Frequency of attacks once in two weeks
3 - Frequency of attacks once in a week
4 - Frequency of attacks twice in a week
5 - Frequency of attacks once or more than once in a day.
2) Duration of attack
0 - No episode of attack
1 - Attack lasting for duration of 1/2 - 1 hr.
2 - Attack lasting for duration of 1 - 6 hr.
3 - Attack lasting for duration of 6 - 12 hr.
4 - Attack lasting for duration of 12 hr.
5 - Attack lasting for duration of more than 12 hours.
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3) Intensity of attack:
0 - Asymptomatic and normal lung function between exacerbations.
1 - Intermittent symptoms < once a week. Brief exacerbation (from a few hours to
few days), night time symptoms < 2 times a month.
2 - Symptoms > once a week but < once per day, exacerbation affect activity &
sleep, night time asthma symptoms > twice a month.
3 - Symptoms daily exacerbations affecting activity and sleep, night time asthma
symptoms > 1 times a week.
4 - Continuous symptoms, frequent exacerbations, frequent night time asthma
symptoms& physical activity limited by asthma symptoms.
4) Shvasakrichhrata :
0 - No sign of Shvasakrichhrata
1 - Mild intercostal retraction, Nasal alae flurring & can speak complete sentences
during dyspnoea.
2 - Intercostal retraction, sterrnocleidomastoid muscle use & speaks in phrases or
partial sentences during dyspnoea.
3 - Tracheosternal retraction, Intercostal retraction, sternocleidomastoid use & speak
in single words during dyspnoea.
4 - Nasal alae flurring & cannot able to speak during dyspnoea.
5 - All accessory muscles are working & not able to speak, expresses by body
language.
5) Asino labhate Saukhyam :
0 - Relief on lying position
1 - Temporarily feels better in sitting posture
2 - Sitting posture gives relief.
3 - Spontaneous sitting posture, can't sleep.
6) Presence of Pranavaha Sroto dushti lakshana :
Absent - 0
Less than 25% - 1
Between 25 - 50% - 2
Between 50 - 75% - 3
More than 75% - 4
7) Kaasa:
0 - No cough
1 - Cough dry without pain / wet with easy expectoration.
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2 - Dry cough with pain &expectoration with slight difficulty.
3 - Dry cough with severe pain stabbing, cutting / feeling of restlessness because of
difficulty in expectoration.
4 - Frequent coughing due to which patient becomes unconscious / Fainting.
8) Kapha Nistivanam :
0 - No Kaphanishtivanam
1 - Kapha nistivanam only in the early morning
2 - Kapha nistivanam 2 - 3 times daily
3 - Always Kapha nistivanam.
9) Kaasatah Sannirudhyate:
0 - No such feeling
1 - Occasional Kasatah Sannirudhyate
2 - Very often Kasatah Sannirudhyate
3 - Always Kasatah Sannirudhyate
10) Shleshma Vimokshante Muhurtam Sukham:
0 - No such feeling
1 - S.V.M. Sukham during attack
2 - Very often S.V.M. sukham
3 - Always S.V.M. sukham
11) Wheezing:
0 - No wheezing
1 - Wheezing only at early morning; doesn’t require any medicine
2 - Wheezing at early morning; requires medicine
3 - Wheezing at early morning & occasionally during day time.
4 - Wheezing throughout the day & requires medicine
5 - Wheezing throughout the day & not responding to any medicine, requires
hospitalization.
12) Ronchi / Crepts:
0 - Absent on normal breathing but few ronchi on forced breathing.
1 - Few scattered bilateral ronchi on normal deep breathing.
2 - Ronchi in between grade 1 & 3 on normal deep breathing.
3 - Innumerable high pitched bilateral ronchi on normal deep breathing.
13) Peenasa:
0 - No Peenasa
1 - Peenasa during attack & subside 1-2 days after attack
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2 - Peenasa during attack & persists for a week after attack
3 - Peenasa very often without attack
4 - Peenasa always persisting
14) Urahshula / Parshvashula:
0 - No Urahshula
1 - Urahshula along with the attack
2 - Very often Urahshula even without attack but relieved by local Snehana &
Swedana
3 - Very often Urahshula without attack & not relieved by local Snehana &
Swedana
4 - Always Urahshula
15) Kanthoddhvansanam (Irritation in throat)
0 - No Kanthoddhvansanam
1 - Occasional Kanthoddhvansanam
2 - Very often Kanthoddhvansanam
3 - Always Kanthoddhvansanam
16) Trit (Trishna) / Vishushkasyata:
0 - No Trit / Vishushkasyata
1 - Occasional Trit / Vishushkasyata
2 - Very often Trit / Vishushkasyata
3 - Always Trit / Vishushkasyata
17) Ushnabhinandati:
0 - No particular
1 - Likes if available
2 - Always prefer
3 - Can't take cold things
AGNI BALA:
18) Jaranashakti:
Scoring according to Jeerna Aahara lakshana present after 6-8 hrs after taking food
They are Utsah, Laghuta , Udgarshuddhi , Kshut ,Trishna pravritti Yathochit malotsarga.
0 - presence of five symptoms
1 - Presence of four symptoms
2 - Presence of three symptoms
3 - Presence of two symptoms
4 - Presence of one symptom
5 - Absence of all the symptoms
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19) Abhyavaharan Shakti :
0 - Taking food in good quantity twice / thrice
1 - Taking food in normal quantity twice a day
2 - Taking food in moderate quantity twice a day
3 - Taking food in less quantity twice a day
4 - Person taking food in less quantity once in a day
5 - Person not at all taking food.
20) Ruchi :
0 - Equally willing towards all the Bhojya padartha
1 - Willing towards some specific Aahara / Rasavisesha
2 - Willing toward only one among Katu/Amla/Madhura food stuffs.
3 - Willing towards only most liking foods not to the other.
4 - Unwilling for food but could take the meal
5 - Totally unwilling for meal.
21) Vaata Mutra Purisha Retasam Mukti :
0 - Occurs easily in normal routine times
1 - Difficulty in defecation but Malapravritti daily with discomfort in abdomen.
2 - Can't pass stool daily & feeling heaviness in abdomen.
3 - Passes stool after 2-3 days having gaseous distension
4- Passes stool after 3-4 days with Grathita, Sakasta Malapravritti & having gaseous
distention with Udgarapravritti.
DEHA BALA:
22) Balavriddhi:
0 - No weakness
1 - Slight weakness
2 - Feeling of weakness but ability to work unaffected
3 - Ability to work affected
4 - Can't do any type of work
23) Swara Varna Yoga :
Texture, Lusture & voice :
2 - Patient looks gloomy
1 - Lethargic & tired
0 - Patient looks cheerful
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24) Sharira Upachaya
0 - No change
1 - Increases weight by 2kg
2 - Increases weight by more than 2kg
SATVABALA:
25) Nidra Labho Yathakalam :
0 - Sound sleep
1 - Sleep gets disturbed in the early morning
2 - Sleeps with disturbed interval & remains unsatisfied with sleep
3 - Disturbed sleep in night tries to compensate in day
4 - No sleep in day / night
26) Sukhena - Cha - Pratibodhanam:
0 - Total relief & feeling of well being at physical & mental level
1 - Improved in physical comfort level
2 - Improved in physical & mental level
3 - Not feeling well & not interested in any work
27) Vaikarikanama - Cha - Swapnanam Adarshanam:
0 - Absent
1 - Occasionally
2 - Daily
28) Mano Buddhi - Indriya Avyapatti:
0 - Enthusiastic, Vigorous, having concentration & interest in routine work
1 - Less enthusiastic & not concentrating but interested in routine work
2 - Less enthusiastic & not interested in routine work
3 - Loss of enthusiasm, concentration & vigor.
Criteria of Assessment:
Symptomatic relief obtained by the treatment given was assessed B.T. (Before Treatment)
and A.T. (After Treatment) with following criteria; they were graded on the basis of scoring
pattern.
1. Frequency of Swasa Vega
0 - No Attack.
1 - 2-3 Times in 3 Week.
2 - 2-3 Times in 2 Week.
3 - 2-3 Times in 1 Week.
18
2. Duration of Attack
0 - No episode of attack
1 - Attack lasting for duration of 10 min.
2 - Attack lasting for duration of 20 min.
3 - Attack lasting for duration of 30 min.
3. No. of emergency med. Taken/ wk.
0 - not needed.
1 - 2-3 doses occasionally in a Week.
2 - 2-3 doses occasionally in Alternate days.
3 - 2-3 doses regularly.
4. Presence of Pranavaha Srotodusti Lakshana
(Dyspnoea / Freq. Exp. / Very restricted Exp. / Prolonged Exp./ With Loud sound painful /
Difficulty in speaking / Sweating )
0 - Absent.
1 - Any 1or 2
2 - Any 2 or 3
3 - More than 4.
5. Asino Labhate Saukhyam (relieved with sitting position)
0 - No effect.
1 - Temporarily feels better.
2 - Sitting posture gives relief, patient can sleep.
3 - Spontaneous sitting posture / can’t Sleep.
6. Kasa (coughing)
0 - Absent.
1 - Cough with expectoration with slight difficulty
2 - Cough with pain difficulty in expectoration, patient can tolerable.
3 - Freq. coughing with more difficulty in expectoration, patient can’t tolerate.
7. Kapha nisthwana (Sputum)
0 - Absent.
1 - Only in morning.
2 - 4-5 times / day.
3 - Continuously.
8. Kasatah sannirudhyata (feeling of unconsciousness in effort to expel out the sputum)
0 - Absent.
1 - During Attack
19
2 - Without attack at any time.
3 - Always.
9. Shleshma vimokshante sukhum (Get relief after expel out the sputum)
0 - Absent.
1 - During Attack
2 - Without attack at any time.
3 - Always
10. Peenasa (Coryza)
0 - Absent.
1 - During attack & subside 1-2 days after attack
2 - During attack & persists for a wk. after attack
3 - Very often without attack
11. Parshvasula (Pain in thoracic region)
0 - No Shula
1 - Along with Attack / Cough
2 - Very often without attack, relived by Snehana / Swedana
3 - Very often even without attack, not relived by Snehana / Swedana
4 - Always.
12. Kanthodhvansanam (Throat irritation)
0 - No
1 - intermittent without cough.
2 - During cough.
3 - without cough.
13. Trita
0 - Normal feeling.
1 - Increased by 4-5 times / day.
2 - Increased by 6-8 times / day.
3 - More than 8 times.
14. Usnabhinandati (Liking for hot food & drink)
0 - No such feeling.
1 - Generally avoid Cold thinks.
2 - Prefer hot drinks.
3 - Always take hot food & drinks.
15. Wheeze
0 - No wheezing
1 - Few wheezing
2 - Few scattered unilateral.
3 - Few scattered bilateral.
20
EXAMPLE 2: AMAVATA
The improvement in the patients were assessed on the basis of Roga Bala, Agni Bala, Deha
Bala and Chetasa Bala which were scored as follows:
60 - Rogabala
20 - Agnibala
10 - Dehabala
10 - Chetasabala
These points are discussed in detail as follows:
• ROGABALA
Rogabala has been given 60 score out of 100 for degree of disease activity and symptoms of
Amavata. It has been further divided into (30+30):
I. 30 score to –
Degree of disease activity to be assessed on the basis of American Rheumatism
Association criteria (modified)
Grade 0 1 2 3
1) Fatigue Not there Work full Patient must Fatigued at
time despite interrupt work rest
fatigue to rest
2) Grip strength 200 mmHg or 198 to 118 to 70 Under
more 120mmHg mmHg 70mmHg
3) Spread of joints Not there 0 to 50 51 to 100 Over 100
4) Westergren ESR (in 0 to 20 21 to 50 50 to 100 Above 100
1st hour)
5) Haemoglobin (gm%) 12.5 or more 12.4 to 11 10.9 to 9.5 <9.5
6) General function All activity Most activity Few activity Little self
without but with cares for self care mainly
difficulty difficulty on chair &
bed
7) Patients estimate Fine Almost well Pretty good Pretty bad
8) Physicians estimate Inactive Minimally Moderately Severely
active active active
Apart from these criteria of ARA (1987) two other criteria were added here.
9) Foot pressure 36-40 kg 31-35 kg 26-30 kg <20 kg
10) Walking time (for 15–20 sec. 21-30 sec. 31-40 sec. >40 sec.
25 feet)
21
II.30 score - Assessed on the basis of the symptoms of Amavata which has been further
subdivided as : (14+10+6)
A. 14 score – To cessation of cardinal symptoms like
a) Sandhishoola (Pain in joints) Score
No pain 0
Mild pain 1
Moderate pain, but no difficulty in moving 2
Slight difficulty in moving due to pain 3
Much difficulty in moving the bodily parts 4
b) Sandhishotha (Swelling in joints)
No swelling 0
Slight swelling 1
Moderate swelling 2
Severe swelling 3
c) Sparshasahyata (Tenderness in joints)
No tenderness 0
Subjective experience of tenderness 1
Wincing of face on pressure 2
Wincing of face and withdrawal of the
affected part on pressure 3
Resist to touch 4
d) Sandhigraha (Stiffness in joints)
No Stiffness or Stiffness lasting for 5 mins. 0
5 min to 2 hrs 1
2 to 8 hrs 2
More than 8 hrs 3
B. 10 score to – Associated symptoms like
a) Jwara, Alasya, Gaurava, Asyavairasya, Daurbalya, Akarmanyata, Utsahahani,
Angamarda, Daha, Trishna were scored as mentioned below –
Symptoms observed before treatment 10
Some relief after treatment 05
Complete relief after treatment 00
No improvement after treatment 10
22
C. 6 score to – Physiological normalcy which was further divided into
a) Vata (i.e. relief in Anaha, Kukshishoola, Kukshikathinya, Antrakujan) 2
b) Mutra (i.e. relief in Bahumutrata) 2
c) Purisha (i.e. relief in Vibandha) 2
Each of above three can be scored as -
- Symptoms observed before treatment 2
- Some relief after treatment 1
- Complete relief after treatment 0
- No improvement after treatment 2
• AGNI BALA
It has been given 20 score out of 100 which has been further divided into (4+8+8).
A. 4 score - To Ruchihi ahara kale (Taste and appetite)
B. 8 score to Abhyavaharanabhilasha (Revival and improvement in hunger)
C. 8 score to Ahara Kala Samyagajaranam (Digestion of ingested food within time) – If
proper at the end of digestion will give Jirna Ahara Lakshana – they are
1) Utsaha
2) Laghuta
3) Udgar Shuddhi
4) Shutta Trishna Pravriti
5) Yathochhita Malotsarga
Scoring according to Jirna Ahara Lakshana
Presence of all (five) symptoms after 6 hrs - 0
Pravara
Presence of four symptoms after 6 hrs - 2
Presence of three symptoms after 6 hrs - 4
Madhyama
Presence of two symptoms after 6 hrs - 6
Presence of one symptom after 6 hours - 8 Avara
• DEHABALA
Dehabala has been further divided into: (3+3+3)
A. 3 score to – Swara Varna Yoga (Revitalization of speech and luster)
B. 3 score to – Sharira Upachaya (increase in body mass/weight & gain in muscle wasting)
C. 3 score to – Balavriddhi (increase in body strength)
• CHETASA BALA
Chetasa bala has been given 12 score which was further divided as : (2+2+3+3)
A. 2 score to – Nidralabho yathakalam (Sleep in proper time and cessation in symptom
Nidra-viparyaya).
23
B. 2 score to – Vaikarika Swapnanama Adarshanam (No pathological dreams)
C. 3 score to – Mana Buddhi Indriya Avyapatti (Proper and unaltered functioning of mind,
intellect and sense organs)
D. 3 score to – Sukhen Cha Pratibodhanam (Feeling of well being)
II. OVERALL ASSESSMENT OF THERAPY
Overall assessment of all the therapies will be done according to calculated score in terms
of:
Complete remission : 0 – 25 score in assessment criteria
Major improvement : 26 – 50 score in assessment criteria
Minor Improvement : 51 - 75 score in assessment criteria
Unchanged : 76-100 score in assessment criteria
EXAMPLE 3: AMLAPITTA
Total 100 score has been divided in following Rogabala, Dehabala, Agnibala and Chetasbala
as follows -
Rogabala 50
Agnibala 25
Deha + Chetasbala 25
Rogabala (50): Rogabala has been given 50 score out of 100, for degree of disease activity
and symptoms. This score has been further subdivided as follows –
Daha -6 Amlodgara -6 Shula -6
Chhardi -5 Adhmana -5 Angasada -5
Gaurava -5 Tama -4 Bhrama - 4 Kampa - 4
Agnibala (25): It has been further divided into as follows.
Aruchi -5 Abhyavaharana Shakti- 7
Avipaka- 7 Purisha Utsarga -6
Dehabala and Chetasbala (25): Looking to the less availability of the symptoms of
Dehabala and Chetasabala both have been grouped in one and 25 score has been further
subdivided as follows -
Shrama -5 Chittodvega- 4 Nidra- 5
Klama- 3 Swapna- 3 feeling of well being -5
There was no any gain or loss of weight before and after the treatment for which Shrama was
only symptoms reported by the patients under the category of Dehabala.
24
Assessment of total effect of therapies: The overall assessment was calculated on the basis
of average improvement in the percentage relief of Rogabala, Agnibala, Deha and
Chetasabala score.
1. Complete remission – 100%
2. Marked improvement – 76% to 99%
3. Improvement – 51% to 75%
4. Mild improvement – 26% to 50%
5. Unchanged – Below 25%
Scoring pattern may be adopted to assess the relief in each symptom as follows-
Rogabala
Daha
• No Daha 0
• Daha in any one area of Udara, Ura, Kukshi/ occasionally for more than half an hour.1
• Daha in any 2 area/ occurs daily for half hour to one hour 2
• Daha occurs daily in more than two area for one hour or more and relieves after
digestion of food or vomiting. 3
• Daha involving most of the areas patient may not sleep at night and does not relieve by
any measure. 4
• Severe degree of Daha involving the whole body like hands, feet or Sarvanga and does
not relieves by any measure. 5
Amlodgara
• No Amlodgara at all 0
• Occasionally during day or night for less than half hour after meals. 1
• Amlodgara occurs daily for two to three times for ½ - 1 hrs. and relieved by sweets,
water and antacids 2
• Amlodgara after every intake of meal any food substance for half to one hour, and
relieved by digestion of food or vomiting 3
• Amlodgara for more than one hour not relieved by any measure 4
• Amlodgara disturbing the patient’s even small amount of fluid regurgitate to patients
mouth (Dantaharsha) 5
Shula
• No pain 0
• Mild/ occasional pain which need not any medication 1
• Pain (abdomen) for less than half an hour and relieved after intake of sweets cold drinks
food antacid milk etc. 2
25
• Abdominal pain due to ingestion of food and relieves after digestion of food or by
vomiting. 3
• Severe unbearable pain which does not subside by any measure and the patient awake
in the night 4
• Unbearable pain associated with frequent vomiting and hematemesis 5
Chhardi/ Hrillasa/ Asyapraseka
• No vomiting at all 0
• Frequency of salivation on every day (Asyapraseka) 1
• Feels sense of nauseating and vomits occasionally (Hrillasa) 2
• Frequency of vomiting is two to three times or more per weeks and comes
whenever Daha or pain is aggravated 3
• Frequency of vomiting is daily 4
• Frequency of vomiting after every meal or even without meals 5
Adhmana
• No Adhmana 0
• Occasionally feelings of distension of abdomen 1
• Daily after intake of food up to 1 hour with mild distension of abdomen 2
• Distension of abdomen up to 1 -3 hours after intake of food 3
• Moderate distension of abdomen up to 6 hours after intake of food 4
• Severe distension of abdomen up to more than 6 hrs after intake of food 5
Tama
• No feeling of Tama 0
• Occasional feeling of Tama 1
• Feeling of Tama < 2-3 times a day 2
• Feeling of Tama 3-6 times a day 3
• Many times a day with problem in maintaining posture, tries to sit 4
Bhrama
• No Reeling of head/ Bhrama 0
• Sometimes feeling of reeling head/ Bhrama 1
• Feeling of reeling head/ Bhrama < 3 times a day 2
• Feeling of reeling head/ Bhrama > 3 times a day 3
• Frequently feeling of reeling head change of posture causes the severe problem 4
26
Kampa
• No presence of Kampa 0
• Occasionally present 1
• Mildly present one times feeble 2
• Moderately present i.e. visible disturbs holding light weight articles like news paper 3
• Severely present not able to do routine work like buttoning, eating etc. 4
Angasada/Gaurava
• No heaviness 0
• Occasionally feeling of heaviness for sometimes in hands and feet 1
• Feeling of heaviness for sometimes in hands and feet not affecting activities of daily
living 2
• Daily feeling of heaviness over body, which leads to Akarmanyata 3
• Most part of the body for long duration 4
• All body for most part of the day 5
Klama
• No Klama 0
• Occasionally feeling of lassitude without Shrama and remains for sometimes and
vanishes 1
• Lassitude without Shrama daily for sometimes 2
• Lassitude without Shrama daily for long duration 3
• Always feels tired and have no enthusiasms 4
Nidra
Paittika
• Even the patient may not sleep in night due to irritation in abdomen 5
• Patient can sleep < 3 hrs with severe irritation in abdomen 4
• Patient can sleep < 3 hrs with moderate irritation in abdomen 3
• Patients can sleep up to 3 – 6 hrs with mild irritation in abdomen 2
• Patient can sleep up to more than 6 hrs without any irritation 1
Kaphaja
• Normal / sound sleep 0
• Patient sleep up to 6 hrs without any disturbance 1
• Sleep deeply up to 8 hrs 2
• Sleeps up to 10 hrs 3
• Sleeps up to > 12 hrs 4
• Even patient may sleep during day time 5
27
Feeling of well being
• Feeling very well 0
• Occasionally feels discomfort 1
• Feels discomfort mildly and not able to concentrate to his work 2
• Feels discomfort moderately and feels depressed 3
• Feels discomfort severely and remains gloomy most of the time 4
• No feeling of well being at all 5
Agnibala
Avipaka
• No Avipaka 0
• Indigestion / prolongation of food digestion period occasionally related to heavy meals 1
• Avipaka occurs daily after each meals takes four to six hours for Udgara shuddhi etc.
lakshana 2
• Daily after each meals / seldom feels hunger but eats the food 3
• Eats only once in a day and does not have hunger by evening 4
• Never gets hungry always heaviness in abdomen followed by vomiting etc. Lakshan 5
Aruchi
• Willing towards all Bhojya Padarth 0
• Unwilling towards some specific Ahara but less than normal 1
• Unwilling towards some specific Rasa i.e. Katu/ Amla/ Madhura food 2
• Unwilling for food but could take the meal 3
• Unwilling toward unliking foods but not to the other 4
• Totally unwilling for meal 5
Abhyavaharana Shakti
• Taking of food in good quantity twice/ trice 0
• Taking food in normal quantity twice a day 1
• Taking food in moderate quantity twice a day 2
• Taking food in less quantity twice a day 3
• Person taking food in less quantity one in a day 4
• Person not at all taking food 5
Purisha Utsarga
• Occurs easily in routine times 0
• Sometimes feeling difficulty in defaecation 1
28
• Difficulty in defaecation but Mala Pravriti daily with discomfort in abdomen 2
• Can’t pass stool daily and feeling heaviness in abdomen 3
• Passes stool after 2 – 3 days having gaseous distension 4
• Passes stool after 3 -4 days with Grathita, Sakasta Mala Pravritti
and having gaseous distension with Udgara Pravritti 5
DEHABALA & CHETAS BALA
Shrama
• No Shrama 0
• 10% feels tired with some amount of work which was tolerable previously 1
• 20% early Shrama with some amount of physical activity 2
• Reduction of up to 50% in physical activity tolerance 3
• Patient get exhausted with minimal physical daily routine work 4
Chittodvega
• No 0
• Associated with less psychic involvement 1
• Associated with moderate psychic involvement 2
• Associated with sever psychic involvement 3
• Associated with psychic involvement as well as somatic involvement 4
Swapna
• No 0
• Occasionally not disturbing sleep 1
• Occasionally, disturbing sleep 2
• Regularly dreams not disturbing sleep 3
• Frequent dreams with severe disturbing of sleep 4
Agni is assessed based on three factors viz Jarana Shakti (Digestion power). Ruchi (Appetite)
and Abhyavaharana shakti (Hunger).
If digestion process is proper, then at the end of digestion, it should give rise to Jeerna Ahara
Lakshana which includes Utsaha (enthusiasm), Laghuta (lightness in the abdomen & body),
Udgara Suddhi (clear belching), Ksudha (hunger), Trisha Pravrtti (thirst) and Yathocita
Malotsarga i.e. proper excretion of excretory material like flatus, urine and feces. According
29
to Ayurveda a normal diet in persons with normal Agni should be digested within 6 hours
though it is individual specific. The Signs of appropriate quantity of food are no
obstruction in heart, no pain in sides(Flanks) no excessive heaviness in abdomen, saturation
of sense organs, cessation of hunger and hunger, ease in standing, sitting, lying down,
movement &movement, easily digestion of food before next food timings (Morning-
evening), promotion and development of strength, complexion and body mass. The scoring
may be given to each of above symptom for assessment of Jarana Shakti.
Note: this scoring is applicable for an individual who ingests normal required quantity of
food in appropriate timings food intake (Aharakala).
Score
1. Absence of all the symptoms 0 Avara
2. Presence of one symptom 1 )
3. Presence of two symptoms 2 Madhyama
4. Presence of three symptoms 3 )
5. Presence of four Symptoms 4 Pravara
6. Presence of All the five symptoms 5 )
Another method of evaluation of Jarana Shakti and Abhyavaharana Shakti is rather a vague
method of Avara (Poor), Madhyama (moderate) and Pravara (Good).
Kshudha Pravritti – Increase in appetite and an individual feels to take food when Kshudha –
hunger is there. Each type of diet has its own time for digestion which is called as Pachana
Kala and when Agnibala is increased Pachana Kala reduces. Thus Pachana kala and
quantity of diet play very important role in deciding the Agnibala. As Agnibala increases, the
Pacana Kala should decrease, even in the same quantity of diet, otherwise when the quantity
is increased, the duration for its digestion should also increase in the same proportion.
30
This can be tested effectively in a therapeutic procedure called Snehapana wherein a
specific quantity of medicated or plain Ghee is administered and for Sneha, ‘Abbyavaharana
Index’ may be graduated as follows -
If the A.B.I. remains less than that of the calculation with the time required to digest
the test dose and accordingly increase every day, then we can say that Agnibala is
increased.
Eg. 30 ml is the Test Dose [T.D.] and it is digested in 3 hrs. then AI = 30/30 = 1
A.B. I. - 1 X 3 = 3.
If 300 ml. dose is digested in 7 hrs. in same person in a later day then
The initial A.B.I. was 3, which was reduced to 0.7 in the same person after some days;
as per simple mathematical calculation the person should take 30 hrs. to digest 300 ml but as
the Agnibala is increased, the time taken for digestion reduced to 7 hours.
Thus it is concluded that Lesser the A.B.I., more will be the Agnivriddhi. So A.B.I.
may be taken as a standard scoring pattern for Ksudhapravritti, with appropriate quantitative
measures, ABI calculation may be taken as a tool for assessment of Agni.
31
Manual part 1: CRF - 1
GENERAL SCREENING PROFORMA – CRF 1
Sl. No.: Registration No.: Date:
Name : Vaya _____Years _____ Months ____ Days
Address Sex - Male / Female
UPASAYA:
Ahara:
Vihara:
Aushadha:
ANUPASHAYA:
Ahara:
Vihara:
Aushadha:
32
Dominant Guna in Diet: G /L / St / U / Sn / R
Dietary habits: Samasana / Adhyasana / Vishamaasana
Regular / Irregular
Other Habits: Tea / Coffee / Cold drinks / others
Quantity per day:
3. VIHAARA:
Danta dhavana: Daily once / twice / after every meal
Datun / Tooth paste / Tooth powder / Danta Manjana Churna
Vyaayaama: Regularly / Irregularly / No / Less / Proper / Excess
Vishraama (Rest): ______hrs. / day; ______hrs. / night
Abhyanga: Regularly / Irregularly / No / Less / Proper / Excess
Snaana: Daily / Irregular; Hot Water / Warm water / Tape
water
4. NIDRAA: Samyaka / Asamyaka; Alpa / Prabhuta / Khandita
_____hrs. /day _____hrs. / night
Swapna Darshana: Yes / No; If Yes, Vaikarika / Avaikarika / __________
5. KOSHTHA - BOWEL:
Santushta / Asantushta; Saama / Niraama
Kathina / well formed / Drava / Sakashtam / Vivarna / Alpa/Muhurmuhuh
Frequency: ______time / day Colour: Odour:
Vatapravrutti: Yes / No; Durgandha: Yes / No
Koshtha: Mridu / Madhya / Krura
33
3)Samhanana: P/M/A
4)Pramaana : Height___ Weight_____ kg
5)Satva: P/M/A
6)Satva(Emot. make-up): Prakrita /Utsahita/Udrikta/Khinna/Avasadita/Bhavanatmaka
7)Saatmya: P/M/A
8)Vyaayaama Shakti: P/M/A
Note:
• Prakriti analysis may be done by using separate proforma attached
• Satva may be evaluated based on tolerance for sufferings (or pain tolerance)
• Vyaayaama Shakti may be evaluated by Tread Mill Test (TMT)
FAMILY PEDIGREE:
History of vegadharana/Vegodeerana:
Vega: Vegadharana since (duration) :
Vega: Vedodheerana since (duration):
OJAS:
VATA PITTA KAPHA
Ojo Visramsa Srama / Sandhi Gatra Sadana
Vislesha
Ojo Vyapat Stabdhata Guru–Gatrata, Tandra,
Nidra
Ojakshaya Mamsa etc.
Dhatuksaya / Moha /
Pralapa, Agyna
Upadhatu Pareeksha:
37
UDAKAVAHA SROTASA PARIKSHAA:
PAREEKSHYA VATA PITTA KAPHA
BHAAVA
Darshana Jihwaa-Taalu- Oustha-
Prashna Kantha- Kloma - Shosha Ati Trishnaa
Sparshana
Talu, Jihva, Netra,
Twak
Upadhatu Pareeksha:
38
Prashna Sitakaamitwa / Alpanidrataa / Valahaani / Indriyadourvalya Mandaagni
Daaha / Kandu / Vishra Gandha / Sadana / Mada /
Katukaasyataa / Amlaasyataa
39
ANNAVAHA SROTASA PARIKSHAA:
PAREEKSHYA VATA PITTA KAPHA
BHAAVA
Darshana Aadhmaana
Sparshana
Prashna Shooloa / Ati-Udgara Pipaasaa / Amla- Anannaabhilashanam /
Katu-Udgara Arochakam / Avipaaka /
Annadwesha / Chhardi /
Madhura Udgara
Ruchi Arasagyata Amla/Tikta Asyata Aruchi/Madhurasyata
Abhyavaharana Vishama Kshudha Atikshudha Anannabhilasha
Shakti
Jarana Shakti Vishama Vidaha Ajeerna
Examination of GIT,
Gall Bladder
X-Ray / USG
Biochemical Concerned / related biochemical investigations
investigations
Agni Pareeksha: P/M/A
ROGA PARIKSHA:
1) DOSHA:-
i) Prithaka (with sub types):
VATA PITTA KAPHA
PR/ UD/ SM /VN/ AP PC/ RJ/ BH/ SD/ AL KL/ AV/ BD/ TR/ SH
ii) Sansarga: Vata-Pitta/Vata-Kapha/Pitta-Kapha
iii) Sannipata : Vata-Pitta- Kapha
iv) Avarana :
2) DOOSHYA:-
Dhatu:- Rasa / Rakta / Mansa / Meda / Asthi / Majja / Shukra
Upadhatu:- Stanya / Raja / Kandara / Sira / Dhamani / Twacha / Snayu
Mala:- Poorisha / Mootra / Sweda / Kapha nishteevana / Pitta / Khamala /
Kesha / Nakha / Akshisneha / Loma / Shmashru
3) SROTASA & SROTODUSHTI TYPE:
4) AGNI: Sama / Vishama / Tikshna / Manda
5) ADHISHTHANA: Ama / Pakwa..............................
6) VYAKTISTHANA: .........................................
7) KRIYAKALA: ...............................
8) ROGAMARGA: Koshtha / Shakha / Marma ...............
9) VYADHI SWARUPA: Chirakaari / Aasukaari
42
NIDAANA:
POORVARUPA:
ROOPA:
UPASHAYA:
ANUPASHAYA:
SAMPRAAPTI:
VYAVACHCHEDAKA NIDANA –
ROGAVINISCHAYA: Diagnosis:
SAADHYAASAADHYATAA: Saadhya / Krichchhrasaadhya / Yaapya / Pratyaakheya
AYUSHAHA PRAMANA PARIKSHAA
VYADHI AVASTHA:
UPADRAVA:
ARISHTA LAKSHANAS (if any)
MANAGEMENT / INTERVENTION
CHIKITSA SOOTRA (Line of treatment)
(A) Drug
(B) Dose and Anupana
(C) Aushadha sevana kala
(D) Pathya
(E) Apathya
(F) Treatment duration
Chikitsa upakrama
PANCHAKARMA:
A) POORVA KARMA:
(A) Rukshana
(B) Deepana / Pachana
(C) Abhyantara Snehapana (According to Koshtha) Sneha Yoga:
st nd rd
1 day ……………... / 2 day ……………… / 3 day ………………
4th day………………. / 5th day ……………… / 6th day ………………. 7th Day………….
(D) Swedana (duration) Sweda prakara:
43
CRITERIA OF ASSESMENT –
ROGA BALA
Signs & Symptoms BT 1st 2nd 3rd AT
AGNI BALA
BT 1st 2nd 3rd AT
Jaranshakti
Abhyavaharanashakti
Ruchi hi aaharakale
Vata mutra purisha retsam mukti
DEHA BALA
BT 1st 2nd 3rd AT
Balavriddhi
Sharira upachaya
Swara varna yoga
SATVA BALA
BT 1st 2nd 3rd AT
Nindra labhoyathakalam
Sukhena cha pratibodhnam
Vaikarikanam cha
swapnanamadarshanam
Mano budhi indriya avyapatti
Note: Prakriti format & Questionnaire to be attached with general screening proforma.
44
Assessment of Prakriti
(to be filled by the research personnel)
Date: Sl. No.
Personal details:
Name: _____________________ ________________ _____________ Marital Status: Married /
single
Sex: Male / Female Age: _______ years Date of Brith: ____ / ___/ _____
Education: __________________ Blood Group: _______ ( ) ve
Occupation: ___________________ Monthly Income: (Rs)__________
Address:
Height: (in cm): ______________ Weight (in Kg)_________
Prakriti findings:
Sr. Subject / Questions Answers – Please tick wherever appropriate
No.
1 Body build Lean Medium Well – built
2 Skin Dryness More moles or Smooth, moist
freckles
3 Hairs Rough Scanty, gray, Plenteous, curly
balding
4 Complexion Dull, darkish Fair, ruddy Whitish (Pale)
5 Tendons & Veins Prominent Normal Well covered
6 Body movements Rapid & unsteady Normal Less
7 Gait Rapid & unsteady Normal Steady & firm
8 Physical exertion Poor endurance Medium Good endurance
9 Resistance to disease Poor Medium Good
10 Hunger /a Appetite Variable Strong, sharp Constant, less
11 Quantity of food Variable Large Small
12 Habit of taking food Fast Frequent Slow
13 Thirst Normal Abundantly Less
14 Perspiration Not specific Profuse, bad smell Constant, less
15 Memory Short-tem Average Long term
16 Sleep Scanty, disrupted Little but sound Abundant, heavy
17 Intolerance to Cold Hot Not specific
18 Initiation to start any Very quickly Medium speed Slowly
work
19 Receptive power Very quickly Average Slowly
20 Response / becoming Very quickly Quick Slowly
excited
21 Speech Quick, talkative, Argumentative, Slow definite, not
45
inconsistent convincing talkative
22 Competitive capacity Don’t like Excellent Handle competitive
competitive competitor stress easily
pressure
23 Mood Change quickly Change slowly Steady, unchangeable
Total V= P= K=
Percentage
Prakriti
7. Your hair is Rough, dry and less Soft, oily and Black, thick and
Premature graying strong
8. Your Eye brows are Thin, irregular Thin Thick and regular
9. Your forehead is Narrow Medium Broad
10. Your appetite is Variable and scanty Good and excessive Constant and less
46
Disturbed
17. Do you get tensed Always Occasionally Never
during difficulties
18. You start the work Quickly After thinking After detailed
thinking
19. Grasping power Excellent Moderate Medium
20. Your memory Poor Excellent Good
21. Your anger For a short span For more time Less
22. You talk to the More As per need Less
unknown persons
23. You dream about Running, flying, Shining objects like River, greenery,
falling. lightening, fire and swimming.
violence
24. Physical activity of Very active Moderate As per Less active
your body is need
25. You speak Fast, talkative Clear cut Slow
26. Your mood Changes quickly Changes slowly Unchangeable
27. Your resistance to Poor Average Good
disease
28. Competitive capacity Don’t like Excellent competitor Handle stress
easily
29. Your financial status Poor, spends Moderate, spends Rich, money
is money quickly on luxuries saver, spends on
food
30. Do you feel In rainy season In summer season In winter season
discomfort while
working
TOTAL
Prakriti: Vata Pitta / Vata Kapha / Pitta Kapha / Tridoshaja / Eka doshaja [Vata / Pitta / Kapha]
47
MANUAL PART 2
48
Kaasa in Shwasa: (Intensity of cough in breathing difficulty attacks)
1 Coughing 0
2 Persistat cough with expectoration, relieving with expectoration 1
3 Persistant cough with occasional repetition with sputum 2
expectoration
4 Persistatn cough with fainting (darkness) 3
Ronchi:
1 No ronchi even upon forced expiration 0
2 Ronchi present upon forced expiration but not audible upon deep 1
breathing
3 A few scattered ronchi audible upon normal deep breathing 2
4 Innumerable low pitched ronchi audible upon normal breathing 3
5 Innumerable high pitched ronchi audible upon normal breathing 4
Crepitations:
1 No crepts upon normal forced expiration 0
2 Crepts audible upon forced expiration but not upon deep breathing 1
3 Few scattered crepts audible upon normal deep breathing 2
4 Innumerable low internsity crepts audible upon normal breathing 3
5 Innumerable high intensity crepts audible upon normal breathing 4
Peak Expiratory Flow Rate (PEFR) – Numerical / quantitative data, grading as per reading
Table on diagnostic criteria: guidelines NAEPP or GINA guidelines may be adopted here.
Spirometry reading - Numerical / quantitative data, grading as per reading.
Breathe holding time (BHT) - Numerical / quantitative data, grading as per reading
49
3 Attack lasting for duration of 20 min. 2
4 Attack lasting for duration of 30 min. 3
Intensity of Srotodushti
50
Shvasakrichhrata – labored breathing
1 No sign of Shvasakrichhrata. 0
2 Mild intercostal retraction, Nasal alae flurring & can speak complete 1
sentences during dyspnoea (labored breathing)
3 Intercostal retraction, sternocleidomastoid muscle use & speaks in 2
phrases or partial sentences during dyspnoea.
4 Tracheosternal retraction, Intercostal retraction, sternocleidomastoid 3
use & speak in single words during dyspnoea.
5 Nasal alae flurring & cannot able to speak during dyspnoea. 4
6 All accessory muscles are working & cannot able to speak, express 5
by body language only.
Shleshma vimokshane sukhum - Get relief after expel out the sputum
1 Feeling comfortable after expulsion of sputum. 0
2 Not Feeling comfortable even after expulsion of sputum. 1
Peenasa - Coryza
1 Absent 0
2 Present 1
51
GRADATION OF SYMPTOMS: UDAKAVAHA SROTAS
Note: Use Visual Analogue Scale to assess the severity of the complaint.
52
On the basis of progressiveness (Dhatugata avastha)
1 Chhardi without involvement of any Dhatukshaya laxana 1
2 Chhardi with Rasa kshaya laxana 2
3 Chhardi with Rakta kshaya laxana 3
4 Chhardi followed by Sanjna nasha 4
1 No daha 0
2 Daha in any one area of udara, ura, kukshi/ occasinally for more 1
than half an hour.
3 Daha in any 2 area/ occurs daily for half hour to one hour 2
4 Daha occurs daily in more than two area for one hour or more and 3
relieves after digestion of food or vomiting.
5 Daha involving most of the areas patient may not sleep at night and 4
does not relieve by any measure.
6 Severe degree of daha involving the whole body like hands, feet or 5
sarvanga and does not relieves by any measure.
1. No Amlodgara at all 0
2. Occasionally during day or night for less than half hour after 1
meals.
3. Amlodgara occurs daily for two to three times for ½ - 1 hrs. and 2
relieved by sweets, water and antacids
4. Amlodgara after every intake of meal any food substance for half 3
to one hour, and relieved by digestion of food or vomiting
5. Amlodgara for more than one hour not relieved by any measure 4
6. Amlodgara disturbing the patients even small amount of fluid 5
regurgitate to patients mouth (danta harsha)
53
Shula (Pain)
1. No pain 0
2. Mild/ occasional pain which need not any medication 1
3. Pain (abdomen) for less than half an hour and relieved after intake 2
of sweets cold drinks food antacid milk etc.
4. Abdominal pain due to ingestion of food and relieves after 3
digestion of food or by vomiting.
5. Severe unbearable pain which does not subside by any measure and 4
the patient awake in the night
6. Unbearable pain associated with frequent vomiting and 5
hamatemesis
Note: Visual Analogue Scale may be used to assess the severity
Chhardi/ Hrillasa/ Asyapraseka (vomiting /Water brush)
1. No vomiting at all 0
2. Frequency of salivation on every day (asyapraseka) 1
3. Feels sense of nauseating and vomits occasionally (Hrillas) 2
4. Frequency of vomiting is two to three times or more per weeks and comes 3
whenever Daha or pain in aggravated.
5. Frequency of vomiting is daily 4
6. Frequency of vomiting after every meal or even without meals. 5
Tama:
1 No feeling of Tama 0
2 Occasional feeling of Tama 1
3 Feeling of Tama < 2-3 times a day 2
4 Feeling of Tama 3-6 times a day 3
5 Many times a day with problem in maintaining posture, tries to sit 4
54
Bhrama
1 No Reeling of head/ Bhrama 0
2 Sometimes feeling of reeling head/ Bhrama 1
3 Feeling of reeling head/ Bhrama < 3 times a day 2
4 Feeling of reeling head/ Bhrama > 3 times a day 3
5 Frequently feeling of reeling head change of posture causes the severe 4
problem
Kampa
1 No presence of Kampa 0
2 Occasionally present 1
3 Mildly present one times feeble 2
4 Moderately present i.e. visible disturbs holding light weight articles like 3
news paper
5 Severely present not able to do routine work like buttoning, eating etc. 4
Angasada/Gaurava
1 No heaviness 0
2 Occasionally feeling of heaviness for sometimes in hands and feet 1
3 Feeling of heaviness for sometimes in hands and feet not affecting activities 2
of daily living
4 Daily feeling of heaviness over body, which leads to Akarmanyata 3
5 Most part of the body for long duration 4
6 All body for most part of the day 5
Klama
1 No klama 0
2 Occasionally feeling of lassitude without Shrama and remains for 1
sometimes and vanishes
3 Lassitude without Shrama daily for sometimes 2
4 Lassitude without Shrama daily for long duration 3
5 Always feels tired and have no enthusiasms 4
Nidra
Paittika
1 Even the patient may not sleep in night due to irritation in abdomen 5
2 Patient can sleep < 3 hrs with severe irritation in abdomen 4
55
3 Patient can sleep < 3 hrs with moderate irritation in abdomen 3
4 Patients can sleep upto 3 – 6 hrs with mild irritation in abdomen 2
5 Patient can sleep upto more than 6 hrs without any irritation 1
Kaphaja
Normal / sound sleep 0
Patient sleep upto 6 hrs without any disturbance 1
Sleep deeply upto 8 hrs 2
Sleeps upto 10 hrs 3
Sleeps upto > 12 hrs 4
Even patient may sleep during day time 5
Note: Nausea profile may be added here [Ref: Muth ER, Sterm RM, et al. Assessment of
psysomatic research 1999].
On the basis of above criteria final gradation of Chhardi can be made as given below:
GRADE - 1
Getting comfort after single vomiting -1
Vomiting since 12 hrs. -1
Kapha expelled out with vomits -1
Chhardi associated with kapha laxana -1
Chhardi without involvement of Dhatukshaya laxana - 1
56
GRADE – 2
1-3 vomiting per day -2
Vomiting for 12 – 24 hrs. -2
Pitta expelled out with vomits -2
Chhardi associated with Pitta laxana -2
Chhardi with Rasa kshaya laxana -2
GRADE – 3
3 – 6 vomiting per day -3
Vomiting duration is of 1 day to 1 week -3
Rakta expelled out with vomits -3
Chhardi associated with Vaayu laxana -3
Chhardi with Rakta kshaya laxana -3
GRADE – 4
> 6 vomiting per day -4
Vomiting duration is of more than a week -4
Purisha expelled out with vomits -4
Chhardi associated with Rakta / other disease laxana- 4
Chhardi followed by Sanjna nasha -4
NOTE: any two or more characteristics found, the same grade should be considered
57
HRIDAYA SPANDANĀDHIKYA (PALPITATION):
1 Absent 0
2 Present only during heavy exercise that subsides itself on rest 1
3 Present during the normal routine activities, but does not disturb 2
normal activities, subsides by rest
4 Present during the normal routine activities but doesn’t subside 3
on rest
5 Present in routine activities, distressful condition, present even in 4
resting condition
KARNAKSHWEDA
1 Absent 0
2 Occasional & Tolerable 1
3 Occasional & Non Tolerable 2
4 Constant & Non Tolerable 3
58
Rakta Mandala – Erythema
1 Normal skin 0
2 Faint or near to normal 1
3 Blanching + red colour 2
4 No blanching + red colour 3
5 Red colour + subcutaneous 4
Unnati - Elevation
1 No elevation 0
2 Elevation can not palpable 1
3 Elevation can be palpable 2
4 Apparently palpable (Approx. about mm) 3
5 Apparently palpable (Approx. more than 1 mm) 4
Aswedana – Anhydrosis
1 Sweating induced on walking 0
2 Sweating induced on brisk walking 1
3 Sweating induced on running 2
4 Sweating induced on walking up steps 3
1 No scaling 0
2 Mild scaling by rubbing/by itching (scaling from some 1
lesionis)
3 Moderate scaling by rubbing/by itching (from all lesions) 2
4 Severe scaling by rubbing / by itching (from all lesions) 3
5 Scaling without rubbing / by itching (from all lesions) 4
60
3 Scaling off between 7 – 15 days 2
4 Scaling off between 4 – 7 days 3
5 Scaling off between 1 – 4 days 4
Aswedanam (Anhydrosis):
1 Normal 0
2 Improvement 1
3 Present in few lesions 2
4 Present in all lesions 3
5 Aswedanam in lesion and uninvolved skin 4
61
Another grade for Nakha dushti. Pitting in nail:
1 No Pitting 0
2 Pitting in 1 finger only 1
3 Pitting in few fingers 2
4 Uncountable pitting 3
5 Uncountable Pitting with nail pathology 4
Scaling: The score was decided depending upon the duration of shedding of scales.
1 No Scaling 0
2 Scaling off between 15 – 28 days 1
3 Scaling off between 7 – 15 days 2
4 Scaling off between 4 – 7 days 3
5 Scaling off between 1 – 4 days 4
Joint involvement:
1 No arthritis 0
2 Slight pain 1
3 Pain present but do not hinder activity 2
4 Pain with deformity 3
Pain with deformity affecting activity & sleep 4
Auspitz sign:
1 Absent 0
2 Improvement 1
3 Present 2
62
Koebner phenomena:
1 Absent 0
2 Improvement 1
3 Present 2
Mamsapradoshaja Vyadhi:
1 Absent 0
2 Present 1
Mutramadhurya (Glycosuria):
1. Absence of Glucose in urine 0
2. Traces of Glucose in urine 1
3. + Glucose in urine 2
4. ++ Glucose in urine 3
5. +++ Glucose in urine 4
6. ++++ Glucose in urine 5
Hasta-Pada-Tala Daha:
1. No Daha 0
2. Hasta -Pada-Tala Daha found occasionally, mild, bearable 1
3. Hasta -Pada-Tala Daha continuous but bearable & not severe 2
4. Hasta -Pada-Tala-Daha continuous and severe & unbearable 3
Kara-Pada Suptata:
1. No suptata 0
2. Kara-Pada Suptata incontinuous 1
3. Kara-Pada Suptata continuous but bearable & not severe 2
4. Kara-Pada Suptata continuous and severe & 3
Unbearable
Note: The Diabetic Nuropathy scale may also be used here
65
Prabhuta Mutrata (Polyuria)
A. Frequency of Urine: A numerical / quantitative data
1. 3 – 5 times per day, no rarely at night 0
2. 6 – 8 times per day, 1 – 2 times per night 1
3. 9 – 11 times per day, 3 – 4 times per night 2
4. > 11 times per day, > 4 times per night 3
Kshudha (Appetite)
1 Regular usual 0
2 Slightly increased (1 – 2 meals) 1
3 Moderately increased (3 – 4 meals ) 2
4 Markedly increased (5 – 6 meals) 3
66
Abhyavaharana Shakti (Hunger):
1 Person taking food in excessive quantity twice in a day 0
2 Person taking food in normal quantity twice in a day 1
3 Person taking food in moderate quantity twice in a day 2
4 Person taking food in less quantity twice in a day 3
5 Person taking food in less quantity once in a day 4
6 Person not at all taking food 5
Kara-Pada-Tala-Daha/Supti (Neuropathy)
1 No Daha 0
2 Kara-pada-tala-daha/Supti incontineous 1
3 Kara-pada-tala-daha/Supti continuous but not severe 2
4 Kara-pada-tala-daha/Supti continuous and severe 3
Swedadhikya (Perspiration)
1 Sweating after heavy work and fast movement or in hot weather 0
2 Profuse sweating after moderate work and movement 1
3 Sweating after little work and movement (stepping ladder etc.) 2
4 Profuse sweating after little work and movement 3
5 Sweating even at rest or in cold weather 4
67
Nidradhikya (Sleep)
1 Normal sleep, 6 – 8 hours/24 hours 0
2 Sleep up to 8 hours/24 hours with Angagaurava 1
3 Sleep up to 8 hours/24 hours with Angagaurava and Jrimbha 2
4 Sleep up to 10 hours/24 hours with Tandra 3
5 Sleep up to >10 hours/24 hours with Tandra & Klama 4
Purishabaddhata (Constipation)
1 Stool passes as per normal schedule 0
2 Passes stool with strain, sometimes takes purgative 1
3 Passes stool after more than 24 hours, frequently takes purgative 2
4 Passes stool after gap of one day, normal purgatives does not 3
work
Pindiko-udveshatan (Cramps)
1 No cramps 0
2 Cramps after walking more than 1 km. 1
3 Cramps after walking 2
4 Cramps after walking ½ km 3
5 Inability in walking even ½ km 4
Tanu madhuryata: Glycosuria – a numerical / quantitative data based on FBS / PPBS / RBS
readings , so grading may be done as on readings.
68
Krichha Vyavayta (Loss of Libido): [Refer Shukravaha srotas also]
1. Normal performance without external stimulation 0
2. Decreased frequency with normal performance 1
3. Decrease frequency with insufficiency 2
4. Normal performance with external stimulation 3
5 No sexual stimulation at all 4
Swedadhikya (Perspiration):
1. Sweating after heavy work and fast movement or in hot weather 0
2. Profuse sweating after moderate work and movement 1
3. Sweating after little work and movement(stepping ladder etc.) 2
4. Profuse sweating after little work and movement 3
5. Sweating even at rest or in cold weather 4
69
Nidradhikya (Increased Sleep):
1. Normal & sound sleep for 6 – 8 hrs./24 hrs. with 0
feeling of lightness and relaxation in the body & mind
2. Sleep >8 -9 hrs./24 hrs. with slight heaviness in the body. 1
3. Sleep >9- 10 hrs./24 hrs. with heaviness in the 2
body associated with Jrimbha
4. Sleep >10 hrs./24 hrs. with heaviness in the body associated with 3
Jrimbha & Tandra
Dantashoola/Dantabheda-
1 No pain 0
2 Mild pain with no associated complaints. 1
3 Discomforting pain aggravated during mastication. 2
4 Distressing pain associated with fever, edema etc. 3
5 Horrible pain. 4
Note: Visual Analogue Scale may be used to assess the severity of pain.
70
Asthi shula/bheda (Pain in bones)
1 No piercing pain in bones. 0
2 Mild piercing pain in bones not affecting daily activities. 1
3 Occasional moderate piercing pain in bones not affecting daily 2
activities. Pain can be relieved by rest no need of medication.
4 Frequently severe piercing pain in bones affecting daily 3
activities. Patient needs medication.
5 Continuous severe piercing pain in bones with restricted 4
movements not relieved even by simple medications.
Note: Visual Analogue Scale may be used to assess the severity of pain.
Vivarnata: Discolouration
1 Absnet 0
2 Present 1
Other classification that can be adapted to assess hairfall in male and females:
Norwood class of assessing hair fall - Male
Ludwig scale for female pattern baldness – Female
71
Sandhi Shaithilya: (Looseness/Weakness of Joints)
1 No feeling of looseness/weakness in joints 0
2 Mild feeling of looseness/weakness in joints. Patient can 1
stand/walk independently without difficulty.
3 Moderate feeling of looseness/weakness in joints. Patient can 2
stand/walk independently with difficulty.
4 Severe feeling of looseness/weakness. Patient can stand/walk 3
only with support (Crutches, cane or walkers).
5 Severe feeling of looseness/weakness. Patient unable to 4
stand/walk even with support (Crutches, cane or walkers).
Rukshata (Dryness)
1 No dryness. 0
2 Occasional dryness without winter season 1
3 Visible dryness, mild dull white streaks after scratching on the 2
skin which disappears after sometime.
4 Dryness/roughness, bright white streaks on the skin remaining 3
for a considerable time.
5 Dryness/roughness and criss-cross visible cracking of skin. 4
Timir-darshanam
1 No tama 0
2 Occasional tama darshana for short duration 1
3 Occasional tama darshana for small duration leads to bhrama. 2
4 Frequent tama darshan for small duration leads to bhrama 3
5 Frequently tama-darshana for longer duration. 4
Arumshika
1 No Arumshika 0
2 Occasional abscess on the scalp with less pain. 1
3 Few abscesses on the scalp. 2
4 Many abscesses on the scalp associated with severe pain, 3
discharge, reduced hair density.
5 Generalized scalp abscesses on the scalp with severe pain, 4
discharge, reduced hair density associated with systemic
symptoms like fever etc.
74
Bone Mineral Density (B.M.D).
t-score (WHO criteria for assessing osteoporosis.)
1 Normal - t score > -1 0
2 Osteopenia - t score between -1 to -2.5. 1
3 Osteoporosis - t score < or = -2.5. 2
4 Severe osteoporosis - t score < -2.5 with one or more fragility 3
fractures.
(Pauline M. Chamaco, Paul D. Miller, Osteoporosis – A guide for clinicians, Walters Kluwer
(India) Pvt. Ltd., New Delhi, World Health Organization criteria for assessing osteoporosis
severity, Page.5)
Pain:
1 No pain 0
2 Occasional pain did not require treatment 1
3 Occasional pain but, required treatment 2
4 Constant dull ache pain, required treatment 3
5 Severe constant pain, but did not show relief even after treatment 4
Note: Visual Analogue Scale may be used to assess the severity of pain.
Burning Micturition:
1 No burning micturition 0
2 Occasional burning micturition 1
3 Occasional burning micturition, required treatment 2
4 Constant burning micturition required treatment 3
5 Constant severe burning micturition but did not show relief even 4
after treatment
Note: Visual Analogue Scale may be used to assess the severity of pain.
77
Dysuria: Krichchrata
1 No dysuria 0
2 Occasional dysuria 1
3 Occasional dysuria which require treatment 2
4 Constant dysuria which require treatment 3
5 Constant severe dysuria but did not show relief 4
even after treatment
Note: Visual Analogue Scale may be used to assess the severity of pain.
78
4. Dravam / Tanu (liquid stool), watery spills throughout the closet basin, 3
includes, Jalopamam, Payabham, Ambutulyam, Udakaiva, Apureesham,
Vitvarjitham
5 Tilapistnibham, Dadhyabham, Vesavarabham, Vitjalam, Vasabham, 4
Medodakasannibham, Tailabham
Note: BRISTOL’S STOLL CHART may be used to assess the consistency of stool mass
Mala pariksha:
- 1. Habits:
1. Regular 0
2. Irregular 1
- 2. Number of motions:
1. 1 time / day 0
2. 2-3 time / day 1
3. 4-5 times / day 2
4 6 –7 times / day 3
5 > 10 times / day 4
-3. Akriti – appearance of stool mass
1. Cylindrical 0
2. Not define 1
-4. Samhatatva: consistency of stool
1. Semisolid 0
2. Hard or Liquid 1
-5. Colour of stool
1. Avishesha 0
2. Bhrisha Durgandhi 1
-7. Jala nimajjana pariksha:
1. Floats in water 0
2. Sinks in water 1
Evaluation of Atisara:
1. Bowel evacuation 3 – 5 times per day 1
Atisarana < 12 hours chronicity
Pitta expelled out with purisha
Atisarana associated with pitta lakshanas
Atisarana without any dhatu lakshanas
2. Bowel evacuation 6 – 8 times per day 2
80
Atisara chronicity 12 – 24 hours
Pitta expelled out with atisara
Atisarana associated with kapha lakshanas
Atisarana with rasa dhatu Kshaya lakshanas
3 > 9 time bowel evacuation / day 3
Atisarana chronicity 1 day to 1 week
Rakta expelled out with atisara
Atisarana associated with vata lakshanas
Atisarana with rakta dhatu Kshaya lakshanas
4 >9 time bowel evacuation / day 4
Chronicity > 1 week
Purisha expelled out with mucus or kapha
Atisarna associated with Rakta / Anya vyadhi
Atisarana followed by Sangyanasha.
Grade – Atisvedanama
1 Normal pattern of Sweating 0
2 Occasional excessive sweating with no features of Atisvedana or Svedavriddhi 1
3 Features of Sveda Vriddhi/Atisveda or localized sweating <100 cm2 during normal 2
room temperature/short burst of profuse sweating not affecting daily routine
activities
4 Features of Sveda Vriddhi /Atisveda with either Daurgandhya or Kandu or Moderate 3
generalized sweating affecting daily routine activity/Episodic sweating eg. Night
sweating
5 Maximum features of Sveda Vriddhi (Kandu, Daurgandhya, Atisveda, Murccha, 4
Trishna, Daha, PittaPrakopa, Sharira Sadana,Jvara,Bhrama,Shyavaraktamandala
Darshana,Pittasra Kopa,Svarasadana,Sandhipida?)/Excessive sweating >100cm2
during normal room temperature or normal psychological condition/sustained
sweating
Note: Objective Parameters may be used for hyperhidrosis such as:
Gravimetric Sweat test (Quantification Test)
Minor’s iodine Starch Test
Mapping out areas of excess sweating
Using Blotting Paper to assess the amount of Sweat
Grade - Asvedanama
1 Normal Sweating pattern 0
2 No feature of Sveda Kshaya/ No sweating even after exposure to heat or 1
stress condition but developing uncomfortable sense of warmth
3 Any 1 feature of Sveda Kshaya/ Slight sweating exposure to heat or 2
stress condition but developing malaise, easy fatigability,
headache/<1000 F
81
4 Any two features of Sveda Kshaya/ No sweating after exposure to heat 3
or stress condition but developing generalized features like nausea,
dizziness, tachycardia, palpitation, but to rule out compensatory
mechanism or heat acclimatization/100 -102 0 F/heat tolerance
5 All the features of Sveda Kshaya (Romachyuti, Stabhdaromata, 4
Sphutanam Tvacha)/ After exposure to heat or stress condition, No
sweating but developing generalized features (Hyperthermia>1030 F),
drowsiness, Hyperapnoea) but ruling out compensatory mechanism or
heat acclimatization/heat tolerance
Grade -Lomaharsha/horripilation
1 No Horripilation 0
2 Occasional Horripilation in presence of external or internal 1
stimuli
3 Mild Horripilation in environmental or psychological status 2
4 Moderate Horripilation in presence of external or internal 3
stimuli
5 Generalized Horripilation in absence of external or internal 4
stimuli
Angamarda (Bodyache):
1 No pain 0
2 Generalized pain of and on during the day 1
3 Generalized pain/ache during most part of the day not affecting any work 2
4 Generalized pain pain/ache throughout the day but person is able to do 3
normal routine
5 Generalized (sarvanga) bodyache/pain enough to affect routine work for all 4
the day
Note: Visual Analogue Scale may be used to assess the severity of pain.
Vignyanam vyavasayena
1 Normal functioning in routine 0
2 Gradual hampered performance in functioning 1
3 Impaired motivation towards functioning often 2
4 Loss of pace and motivation in functioning 3
Moha – Avijnanena
1 Normal functioning capacity 0
2 Gradual affliction towards objects 1
3 Increased affliction, oftenly towards objects 2
4 Totally involvement and affliction with objects 3
84
Shoka Dainyena i.e. “Rodanadi” (Chakrapani)
1 No feeling of Sorrowness 0
2 Feels inferiority and sorrow at occasion 1
3 Inferiority complexes and greedy oftenly 2
4 Weeps and feels inferior very frequently 3
Bhayam – Vishadena
1 No fear 0
2 Fearful only at reasonable cause 1
3 Fearful even in reasonable cause 2
4 Always fearful emotion 3
Sandnya namagrahanena
1 Completely attentive in all occasions 0
2 Attentive occasionally 1
3 Attentive rarely 2
4 Absolutely no attentiveness 3
Smriti smaranena
1 Very good in recalling and remembering 0
2 Recalls and remembers with difficulty 1
3 Delayed recall and remembers with difficulty 2
4 Delayed recall and remembers with confusion 3
Hriya apatrapanena
1 Shyness intact always completely 0
2 Feeling of shyness in unknown atmosphere 1
3 Feeling of shyness only in front of some unknown persons 2
4 No shyness at all 3
Shila anushilanena
1 Very good conduct at all instances 0
2 Impaired conduct only at occasions 1
3 Impaired conduct recurrently 2
4 Totally abnormal conduct 3
GAURAVA - heavyness
1. Absent 0
2. Occassional gaurava 1
3. Frequently 2
4. Regular 3
Pipasa – thirst
1 No excessive thirst 0
2 Upto 1.5 times the normal thirst 1
3 Upto 2 times the normal thirst 2
4 Upto 2.5 times the normal thirst 3
5 Upto 3 times the normal thirst 4
Note: It is a numerical quantitative data and so should be based on quantity of liquid
consumed per day
Kandu – Pruritis
1 Never 0
2 Rarely 1
3 Sometimes 2
4 Often 3
5 All the times 4
Sweda – sweating
1 Normal sweating (Sweating) 0
2 Mild sweating 1
3 Mild sweating after exercise 2
4 No sweating – even after exercise 3
89
Srava – discharge (exudation)
1 No Srava 0
2 Mild srava after itching 1
3 Moderate srava without itching 2
4 Severe srava without itching 3
Vedana – Pain
1 No vedana 0
2 Mild vedana 1
3 Moderate vedana 2
4 Severe vedana 3
Note: Visual Analogue Scale may be used here.
Kandu – Itching
1 No itching 0
2 Mild / occasional itching 1
3 Moderate frequent itching 2
4 Severe frequent itching 3
5 Very severe itching, which disturb sleep and other routine 4
activities.
Rukshata - Dryness
1 No line on scrubbing with nail 0
2 Faint line on scrubbing by nail 1
3 Linings and even words can be written on scrubbing by nail 2
4 Excessive Ruksata leading to itching 3
5 Ruksata leading to crack formulation and Bleeding 4
Nidra - Sleep
1 Sound Sleep 0
2 Sleep sound when interrupted can sleep again 1
3 Sleep sound when interrupted can’t again 2
4 Disturbed sleep but can sleep for few hrs 3
90
Kasa – cough
1 Abent 0
2 Few times, does not need medication 1
3 Frequent coughing, can be controlled by medication 2
4 Very frequent coughing not even controlled by medica tion 3
Daurbalya (Weakness):
1. Can do routine exercise/work 0
2. Can do moderate exercise with hesitancy 1
3. Can do mild exercise only, with difficulty 2
4. Can not do mild exercise too 3
Another grading for Daurbalya (General Debility)
1 No daurbalya 0
2 Not able to perform strenuous activity. 1
3 Not able to perform moderate activity. 2
4 Cannot perform moderate activity but can perform mild 3
activity without any difficulty.
5 Even mild activities cannot be performed. 4
Daurbalya (General Debility):
1 No daurbalya 0
2 Not able to perform strenuous activity. 1
3 Not able to perform moderate activity. 2
4 Cannot perform moderate activity but can perform mild 3
activity without any difficulty.
5 Even mild activities cannot be performed 4
NOTE: For assessment of Daurbalya – TM Test may be adopted
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Utsaha hani : Aalasya
1. No Alasya (doing work satisfactory with) proper vigor in time 0
2. Doing work with desire with initiation but late in time 1
3. Does work without desire with lot of mental pressure and late in time 2
4. Does not initiate work, does little work very slowly 3
5. Doesn’t take initiative to work neither want to work even after pressure 4
SHRAMA - fatigue
1 No fatigue 0
2 Fatigue occasionally on doing heavy work 1
3 In carrying out routine work 2
4 Even without doing work 3
Vibandham – constipation
1. 1 time / day 0
2. 1 time / 2 days 1
3. 1 time / 3 days 2
4. 1 time / 4 days 3
5. 1 time / 54 days 4
6. 1 time / 6 dyas 5
7. 1 time in more than 7 days 6
Parushya - dryness
1 No dryness 0
2 Visible dryness of skin with no roughness, mild (fade) dull white 1
streak after scratching on to skin, disappearing after sometime (Ruksha)
3 Dryness with roughness, bright white streak on scratching on to the 2
skin remaining for a considerable time (Khara)
4 Dryness, roughness, slight thickening of the skin with visible criss- 3
cross marking with no cracking of the skin
5 Dryness, roughness, slight thickening of the skin with visible criss- 4
cross marking with cracking of the skin (Daruna)
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Paridaha - burning sensation
1 No Burning Sensation 0
2 Occasional Localised Burning Sensation 1
3 Localised mild Burning sensation in a particular hr.of day 2
4 Burning sensation throughout the day but tolerable and relieved after 3
cold medications e.g.Mahatikta Ghrita for Ext.or Int.
application,Dhanyaka hima for Int.application
5 Intolerable(Affecting daily routine activity) generalized burning 4
sensation throughout the day which can’t be relieved by any cold
medications e.g.Mahatikta Ghrita for Ext.or Int. application,Dhanyaka
hima for Int.application
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Signs & Symptoms produced by Ama in General (Due to the circulation of
Sama Rasa Dhatu)
Srotorodha (obstruction to the channels cell pores) - Present / Absent
Bala Bhramsa (loss of strength) - Present / Absent
Gaurava (feeling of heaviness of the body) - Present / Absent
Anilmudhata (inactivity of Vaata) - Present / Absent
Alasya (Lassitud) - Present / Absent
Apakti (Indigestion) - Present / Absent
Nishthiva (Expectoration of Sputum) - Present / Absent
Malasanga (Accumulation of waste materials in the body) - Present / Absent
Aruchi (loss of taste / appetite) - Present / Absent
Kiama (exhaustion) - Present / Absent
VAATA
SAMA LAKSHANA
Vibandha (constipation) - Present / Absent
Agnisada (poor digestive activity) - Present / Absent
Antrakujan (Intestinal gorgulings) - Present / Absent
Angashula (pain in the body parts) - Present / Absent
Sotha (Odema or Swelling) - Present / Absent
Nistoda (pain moving simultaneously to different parts causing distress & catching) – Y / N
Pain incresing by anointing oils, exposure to sunlight, on cloudy days & during nights. Y/ N
PITTA
SAMA LAKSHANA
Amlika(sour belching) - Present / Absent
Kanthahriddaha (burning sensation in the throat and region of the heart) - Present / Absent
Elimination of foul smell - Present / Absent
Greenish blue, sour, thick and heavy Pitta comes out of the body - Present / Absent
(either in vomit or purgation)
KAPHA
SAMA LAKSHANA
Avila (dirty) Phlegm - Present / Absent
Tantula (thready) phlegm - Present / Absent
Styana (thick, solid) phlegm - Present / Absent
Durgandha (foul smelling) phlegm - Present / Absent
Phlegm accumulates in the throat - Present / Absent
Phlegm obstructon to belching - Present / Absent
Loss of hunger - Present / Absent
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AGNIBALA
Jaranashakti
Scoring according to Jeerna Aahara lakshana present after 4-6 hrs after taking food. They are
Utsah, Laghuta, Udgarshuddhi, Kshut, Trishna pravritti Yathochit malotsarga.
Presence of five symptoms 0
Presence of four symptoms 1
Presence of three symptoms 2
Presence of two symptoms 3
Presence of one symptom 4
Absence of all the symptoms 5
Abhyavaharan Shakti
Taking food in good quantity twice / thrice 0
Taking food in normal quantity twice a day 1
Taking food in moderate quantity twice a day 2
Taking food in less quantity twice a day 3
Person taking food in less quantity once in a day 4
Person not at all taking food. 5
Ruchi
Equally willing towards all the Bhojya padartha. 0
Willing towards some specific Aahara / Rasavisesha 1
Willing toward only one among Katu/Amla/Madhura food stuffs. 2
Willing towards only most liking foods not to the other. 3
Unwilling for food but could take the meal 4
Totally unwilling for meal. 5
DEHA BALA
Balavriddhi
No weakness 0
Slight weakness 1
Feeling of weakness but ability to work unaffected 2
Ability to work affected 3
Can't do any type of work 4
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Swara Varna Yoga (Texture, Lusture & voice)
Patients look cheerful 0
Lethargic & tired 1
Patient look gloomy 2
Sharira Upachaya – body built (height, weight etc.)
As recorded before and after treatment
SATVABALA
Nidra Labho Yathakalam (adequate sleep at night)
Sound sleep 0
Sleep gets disturbed in the early morning 1
Sleeps with disturbed interval & remains unsatisfied with sleep 2
Disturbed sleep in night tries to compensate in day 3
No sleep in night 4
Sleep neither at night nor at night hours 5
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GUIDELINES FOR CLINICAL RESEARCH METHODOLOGY IN AYURVEDA
101
INSTITUTE FOR POST GRADUATE TEACHING & RESEARCH IN AYURVEDA, JAMNGAR.
Experts meet on “Developing Guidelines for Clinical Research methodology in Ayurveda”
5th & 6th March, 2011
Prof. KS Dhiman, Prof. Nishteshwar, Prof. VD Shukla, Dr. KS Patel, Dr. SK Gupta, Dr. Mahesh Vyas, Dr.
LP Dei, and Dr. AD Dave as heads of various departments were present in the program and Prof. MS
Baghel, Director of the Institute and Chief Investigator in the project and Dr. Rajagopala S,
Investigator were also present. Apart from the above members, few nominated Ph.D. scholars of
various departments too took active participation in the meeting by giving technical support and
other necessary supports.
The meeting started with a formal inauguration at 09.30 AM on 5th march 2011 and the venue was
the committee room of IPG&RA, Jamnagar. Prof. CP Shukla, a renowned Ayurvedic physician and
local expert member of the meeting inaugurated the program by lighting the lamp.
Prof. MS Baghel, Director of IPGT&RA welcomed the gathering and introduced the theme of the
meeting, he also stressed on the need of a separate research methodology and guidelines for pure
Ayurvedic clinical research. Till date what so ever research works have been carried out have
contributed to the modern medicine at large, not to Ayurveda specific. There are ample of disparity
among the gradation of symptoms adopted at different centers and this has lead to disparity in
results as well as reproducibility of the data and methodology. With these in mind a workshop was
conducted in November 2009, and the outcome of the workshop is presented before the expert
group he added.
Prof. CP Shukla in his inaugural address highlighted the importance of clinical examination and
evaluation of a clinical study as per Ayurvedic methods which are being supported by the classical
texts like Charaka Samhita. There are three methods of treatment now a day adopted by many i.e.
Ayurvedic diagnosis – Ayurvedic treatment; Modern diagnosis – modern treatment and Modern
diagnosis – Ayurvedic treatment. And the third modality is adopted by him, which is suitable for the
present day he said. The established techniques of diagnosis of a disease are to be adopted and
efforts to be made to interpret it with Ayurvedic fundamentals, and he quoted many examples for
the same. He also shared some of his clinical experiences with the gathering.
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Prof. Gurdip Singh, an external expert member commented his opinion and said it is the need of the
hour to have this type of efforts, this will help in producing uniformity in clinical research and there
will be chances of reproducibility of the data too. He emphasized more on the uniformity in
approach, gradation, out come and also in presentation for international acceptance.
Dr. Rammanohar opined that the effort is good, and CRF 1 circulated should be treated as initial
screening proforma and it may be put for field trial first for validation and corrections needed if any.
The symptoms should be first classified in to subjective and objective and each symptom needs
specific definition as it is given in Ayurveda specific to the context.
Dr. G Shrinivas Acharya opined that biological variations are not given due importance in the
modern clinical research, but it is different in Ayurveda, biological variations are many and play vital
role in Ayurveda therapeutics.
Prof. VD Shukla : Vyadhipratyatma lakshana should be taken in to consideration for gradation. Roga
prakriti, vyadhi prakriti, rogi prakriti, roga bala, rogi bala etc. are to be considered before hand.
The expert group after the inauguration and introduction of the program, started to look into the
materials in detail, as per the program schedule, and on the second day the following points were
discussed during the closing ceremony:
Prof. Gurdip Singh: Drug trails and therapeutic trails are different particularly with reference to
Ayurveda, which has multiple drug approach as well as multiple therapeutic procedure are involved
in treatment of one disease. Approach of Ayurveda to a patient is different from that of modern
medicine and so is the research approach too. Till date more than 80 medicinal plants have been
added to Indian Pharmacopoeia of modern medicine, but no substantial contribution has been made
to Ayurveda by the existing research protocol and methodology. Biological variations are not given
importance in modern research but in Ayurveda biological variations play very vital role.
Prof. G Shrinivas Acharya: Variables are many , data is less, data generation is needed. No one
protocol is fit to all patients of same disease, Drug trail is different for Ayurveda trail
Dr. Rammanohar: Variable to be defined first, one variable only to be kept in question in the clinical
trails, all other variable should be constant in the inclusion criteria, to avoid the bias. Base proforma
should have maximum variables in it. Specified proforma should have minimum variable in it.
Stratified sampling is better in variable selection, Principles and practice of Ayurveda: principles
remained static and practice went on changing,
Prof. CP Shukla: Dosha hara V/s Vyadhihara drugs are to be assessed for their efficacy and Diagnosis
and Samprapti of Ayurveda should be given more stress in Ayurvedic clinical research.
At the end of the program Prof. MS Baghel, Chief Investigator in the project gave the concluding
remarks, all the suggestions made by the experts in the meeting will be incorporated in the
corrected version of the document and will be submitted to the sponsoring agency i.e. WHO, he
added.
The meeting ended with thanks to all experts and participants by Dr. Rajagopala S, the investigator
of the project.
Refreshments, High tea, and working lunch etc. were provided to all participants during the meeting
hours of 2 days.
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Expert meet: 5th & 6th March, 2011, IPGT&RA, Jamnagar.
Name & address of Experts attended the Expert Meet:
104
Institute for Post Graduate Teaching & Research in Ayurveda
GUJARAT AYURVED UNIVERSITY, JAMNAGAR
National Workshop on developing Guidelines for
Clinical Research Methodology in Ayurveda
28th to 30th November 2009
Introduction:
A national workshop on developing guidelines for clinical research in Ayurveda was
conducted from 28th November 2009 to 30th November 2009 at IPGT&&RA, Gujarat Ayurved
University, Jamnagar.
This program was financially sponsored by WHO Country Office India, New Delhi,
vide sticker No. SE/09/104507, a sum of Rs. 05, 41, 000/- was sanctioned by WHO for
conduction of the workshop.
A total of 30 persons were invited from outside Jamnagar city as resource persons
for this workshop and 13 teaching faculty members of IPGT&RA were nominated as
resource persons. All the resource persons were accommodated in the guest house of the
institute. High tea was served for all the participants during the workshop days. All the
participants were given with TA and DA as per WHO DFC norms.
All the teachers and scholars of PG and Ph.D. actively participated in the workshop,
the official machinery [IPGT&RA office, Accounts Dept.] too were in action for all these
three days. The brief details of the 3 days workshop is as under:
Day 1: 28.11.2009; Saturday
Registration: 09.00 AM to 10.00 AM
30 resource persons from outside Jamnagar, 13 teaching faculty from Institute for
Post Graduate Teaching & Research in Ayurveda registered in the workshop. All registered
resource persons were distributed with a Kit Bag containing writing pad, pen, photocopy
materials and a CD containing technical materials. 23 faculty members and 129 PG and Ph.D.
scholars of Institute also got registered in the workshop. The list of participants is enclosed.
Inauguration: 10.00 AM to 12.00 Noon
The inaugural ceremony was chaired by Hon’ble Vice Chancellor and Director of the
Institute Prof. M. S. Baghel. Dr. Nandini Kumar Ex Dy. DG from ICMR, Dr. Manoj Nesari
from Dept. of AYUAH, Prof. R. H. Singh, Professor Emeritus, BHU, Prof. Gurdip Singh
Director (PG Studies) SDMCA, Hassan were on the dais as guests of honour, and Prof. H. M.
Chandola, Dean of the institute was also on the dais.
The program started with lighting the lamp by dignitaries and prayer to Lord
Dhanwantari.
Prof. H. M Chandola, Dean and Head of department of Kayachikitsa offered the
welcome address followed by floral welcome.
Prof. Gurdip Singh in his opening remark highlighted the importance of Ayurvedic
pathogenesis and how it is different from modern approach, accordingly the research
105
approach in clinical medicine too varies he added, and the present workshop has come in
right time and he wished for the success of the workshop.
Dr. Manoj Nesari in his opening address highlighted the different issues present
before the Ministry and AYUSH department pertaining to Ayurveda and its global
acceptance. He touched the different areas like ICD 11 classification for diseases in
Ayurveda, GMP & GCP norms, the different guidelines available for Traditional Medicines,
and he too felt the need of a separate guideline for Ayurveda in particular without hurting
its holistic approach.
This was followed by 1st scientific presentation along with guest address by Prof. R.
H. Singh.
Prof. Singh in his presentation on the topic “Development of Research Methodology
in Ayurveda - Creating Clinical Protocols”, briefed why research is required for Ayurveda
which is a time tested system of medicine, and the early attempts for the same by national
agencies such as RRL Jammu, CDRI Lucknow, CCRAS, AYUSH, GTP project etc. there is a 2
fold research requirement in Ayurveda i.e. first one for the science of Ayurveda and the
second one is for therapeutics in Ayurveda he added. The emerging issues in research, the
sectorial knowledge base issues were also touched by him in the address. Trust, Truth and
Team are the basic requirements for any research activity he added. He also suggested
some strategies for the action in this regard and highlighted the priority areas. His
conclusions were:
• Thus there is a need of new strategy & new methodology of research in Ayurved. The
ongoing research using conventional methodology may bring some minor benefits to
conventional Modern medicine without any major break through. The major inputs to
Ayurveda are still more remote.
• Hence Ayurved has to be studied and investigated as it is, critically adapting an
Ayurvedic approach in tune with its basic principles. This needs new protocols.
• However the technical tools will have to be borrowed from modern basic and
biosciences critically developed through an intense interface between Ayurved and
counterpart sciences.
The second scientific presentation was presented by Dr. Nandini K. Kumar, in her
presentation she highlighted WHO TRM protocol, IMCR ethical guidelines, ICH guidelines
etc. along with GCP norms. The areas where Ayurveda can contribute effectively was also
highlighted along with problems for modern world to accept ayurvedic researches. Safety of
herbals in modern times are matters of concern because of - Mistaken use of wrong species,
Adulteration, Innate toxicity, Incorrect dosing, Drug-herb interaction and Misuse as OTC
products. Traditional medical ethics - Rules for a good physician as told by Charaka was also
highlighted in her speech. For traditional medicines used traditionally for number of years,
no efficacy tests required, but validation for evidence-based medicine are required – reverse
pharmacology and here the scientific validation is to be done through trial design
incorporating appropriate GCP guidelines, she opined. Essential – To be done only when a
competent Ayurvedic, Siddha or Unani physician is one of the investigators or collaborators
in such a clinical trial. Under ethical consideration points she opined that based on
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references in ancient literature of Traditional System of Medicine, no Modern Medicine
expert can carry out clinical evaluation of the plant; and the necessity of the joint evaluation
clinical trial with associate specialist from these systems. While framing a Scientific Protocol
Design the following are to be kept in mind - Justification of research topic, Preparation of
formulation , Enrollment - Informed consent, Conduct of trial, Monitoring, and Statistical
evaluation - usefulness sometimes difficult to explain. The Problems of Research Design are
Complex interventions, Holistic, Individualized , Focus on Symptoms, rather than Disease,
Intra & inter variation in response. Problems of RCT are Broad exclusion criteria/ highly
selective patient recruitment, Patient’s preference for particular treatment, easy access to
marketed products may confound results in control group, Finding appropriate control drug
is difficult many times, Double blinding not fool proof, Multiple similar studies in same ward
detrimental. the Challenges in Clinical Trials on TRM as highlighted by her are - Use of
placebo, Use of standard therapy in the control arm, Informed Consent process & patient
information sheet, Compensation/Insurance coverage, Access to products after Trial, Post
trial responsibilities , Loss of basic concepts, Choice of drugs - use of placebo/ standard
therapy in the control arm ?, Informed Consent process & patient information sheet,
Recruitment for self limited disease in rigorously investigated study difficult, and Migratory
population/ drop outs in follow-up studies. She concluded with the following - Classification
of traditional medicine in India is unique, Ethical and regulatory requirement are same as for
synthetic drugs except in case of reverse pharmacology, Multidisciplinary approach is
needed in traditional medicine research, conduct of research as per ICMR and GCP
guidelines (ASU in future) should be made mandatory, national and International
collaborative research works should be planned and the impact of traditional medicine on
national health economy is potentially great.
Prof. R. R. Dwivedi delivered the 3rd technical presentation of the inaugural session,
he highlighted the areas of research wherein scholars often face problems particularly in
evaluation. The concept of research and research methodologies are well explained n
ancient texts as Pratijna – Problem, Sthapana – Hypothesis, Hetu – Reasoning - Aims &
Objectives, Udadaharana - practical, experimentation, collection of data, Upanaya –
interpretation & Discussion and Nigmana – Conclusion, and it is similar to the modern
concept in research too he added. Tantra-Yukti, Tatchilya, Vyakhya, Arthashraya, Kalpana
etc. for Literary Research, there are reference on Pharmacological Research [Ca.Su.26],
Pharmacognostic Research, [Ca.Vi.8], Pharmaceutical Research [Ca.Ka.1] in the classical
texts. Āyurvedic Science believes in treating man as a whole & using drug as a whole; the
holistic approach of Ayurveda in context of the different kinds of the Researches like Drug &
Dietetic Research, Diagnostic Research, Clinical Research etc. were also highlighted by him.
The ‘Pramanas’ could become the parameters of research for the enhancement of Good
Clinical Practice (GCP) he added. Difficulties in selection of problem in regarding their
priorities as well as concern to their discipline, problem in regarding the formulation of
hypothesis, Vague selection of the Aims & Objectives, Non availability of standard
parameters for material and in designing the different method for a specific plan, doubts in
regarding use and interpretations of modern tools and controversies in techniques of
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advanced medical sciences, Lesser number of data material, not well valuable discussion at
par in relation to the hypothesis, discipline and as per the aims and objectives etc. are the
problems faced by research scholars of today.
Prof. M. S. Baghel in his presidential address and presentation highlighted the need
of uniformity in research which is the need of the day. He overviewed the present status of
Ayurvedic Clinical Research and sectarian interest of the science is not preserved properly
he added. The 12 point examination explained by Charaka is the most suited examination
required to be adopted in Clinical research and the general principles as laid by ICMR ethical
code are to be followed he added. Assessment criteria as per Ayurveda and karya of end
point should be Dhatu Saamyam (Equilibrium of Dhatus) and roga bala, rogibala or
quality of life parameters are explained in Ayurveda under the heading of Agni bala,
dehabala, and chetasa bala. A Research Proforma based on Conceptualization of Samprapti
Process viz. Dosha, Dooshya, Srotasa , Rogi – Roga Pariksha (Ekvidha, dwividha, trividha,
chaturvidha, Panchavidha, Shad Vidha, Ashtavidha, Dashvidha, Dwadashvidha Pariksha) is
needed and following the same guidelines, he presented a general CRF for evaluation of
patients without much repetitions and covering all points of Ayurvedic Clinical evaluation
i.e. Roga Bala, Rogi Bala, Agni Bala and Chetasa Bala. He concluded his presentation with a
warm wish for the successful completion of the workshop.
The program was compared and the vote of thanks was given by Dr. Rajagopala S.
With this a short break was given for the session.
st
1 scientific deliberation: 12.15 PM to 01.30 PM
The first scientific deliberation started after the short break and this session was
chaired by Prof. H. M. Chandola, Co-chaired by Dr. A. R. Dave and Dr. Mandeep Kaur acted
as moderator. There were 2 scientific presentations in this session. The brief details of
presentations are given below:
The first presentation in this session was by Dr. Rammanohar, on the topic
“Suggestions on clinical research suitable for traditional medicines”. In his lucid presentation
he highlighted the lacunae in traditional medicine and suggested suitable modifications to
fill this lacunae. The presentation was well received by the hall.
The second presentation was delivered by Prof. Gurdip Singh, and his topic of
deliberation was “Problems of preparing ayurvedic research format”; he highlighted the
common research format generally followed by research scholars in majority of the
institutions. He also discussed various points of the format like dashavidha pariksha, srotas
pariksha etc. and highlighted the areas of problem in filling and maintaining this format, the
subject was open for discussion.
The house dispersed for lunch after this deliberation.
Post lunch sessions:
The house reassembled at 3.00 PM after the lunch break and the theme of this
session was “Preparation of general clinical research protocol for ayurvedic clinical
research”. The session was chaired by Dr. Nandini Kumar and Co-chaired by
Prof. K. S. Dhiman and moderator was Dr. Ravinarayana Acharya.
108
In the first scientific deliberation of this session Dr. Dilip Gadgil presented a talk on
topic “Problems in grading ayurvedic symptomatology”. Ayurvedic terms for symptoms are
to be identified in particular context, the adjectives of these symptoms are to be thoroughly
studied for gradation of them, the visual analogue for subjective symptoms like pain may be
used wherever necessary and logical consideration of particular symptoms are necessary for
gradation of these subjective symptoms he concluded.
The next presentation was delivered by Dr. Sulochana Bhat and she spoke on
“Application of good clinical practice (GCP) in Ayurvedic clinical trials - difficulties and
possible solutions”. In her presentation she focused on topics - The two main
recommendations of GCP are – it should be scientific, authenticity of biomedical should be
there with data be generated, ethically sound, and the protection of the rights of human
subjects should be well preserved. The oobjectives of Ayurvedic clinical trials should aim at
creating the evidence that is understandable and acceptable by the Biomedical Researchers,
Doctors, Academicians, Policy makers, Industry as well as by the Consumers. So the
contemporary guidelines framed should be integral in nature. The problem areas in
Ayurveda are - system specific, lack of standardization, non-availability of Preclinical Safety/
toxicity/ efficacy data, Non chemical entities- veerya, vipaka, prabhava or relying on
principles like doshaghnata, Panchabhautikatwa etc. and diagnosis as per Ayurvedic
principles is poorly understood. For e.g. differentiation between tamaka shwasa &
mahashwasa is clinically not clear. The selection of outcome parameters, multiple
interventions- medicines, procedures, life style, diet etc. which are individualistic and are
difficult to monitor for the compliance, conclude which intervention has what role and try to
adopt gold standards. The present requirements are motivation and orientation of research
scholars, the AYUSH specific Guidelines for Methodology of research, Interdisciplinary
integration and Dissemination i.e. Publication of the research outcome. It is essential to
register in Clinical trial registry before the starting of the work and once the work is over,
clinical trial reporting is essential. She concluded with remarks - Identify the suitable
guideline for reference- WHO, ICMR, CDSCO; Prepare a frame work for general protocol;
Identify priority areas and specific diseases according to ICD 10….; Prepare a list of general
parameters as per Ayurveda to be applied in all the trials for all the subjects; and Prepare
the list of outcome parameters and the criteria for the assessment of the results of all the
identified priority diseases.
These two presentations were followed by open house discussion and an active
discussion took place in the house. At the end Dr. Nandini Kumar gave her chairperson’s
remarks.
The second session of the afternoon was chaired by Prof. R. H. Singh and Co-chaired
by Dr. T. N. Pandya and Dr. Anup Thakar acted as moderator.
In this session one technical presentation was delivered by Prof. Tanuja Nesari on
the topic of “Guideline for Clinical Research in Ayurveda”. She highlighted the need for a
specific guideline considering the holistic approach and fundamental principles of Ayurveda
and suggested that ICH – GCP guidelines are suitable for Ayurveda. She also highlighted the
109
assessment of mental status as per Ayurveda. The subject of case documentation was also
touched in her speech.
This presentation was followed by open house discussion and an active in house
discussion took place for about one hour.
The working groups were formed at the end of the session and 11 different working
groups were made and were assigned with specific task. They were asked to assemble at
09.00 AM on the second day at designated venue. 11 different venues were also made
ready for the purpose.
The house dispersed with thanks to the chair.
Day 2: 29.11.2009; Sunday
Working Group meetings
The 11 different working groups met at designated venues and started working from
09.00 AM, with a short lunch break at 01.00 PM the group reassembled and continued their
work till 04.00 PM. These working groups were having experts and coordinator among the
teachers of the institute. PG and Ph.D. scholars provided help in discussions.
From 04.00 PM onwards the pre-final presentation by each group took place in the
main seminar hall of the institute. After presentation by each group, the subject was open
for discussion. The session was chaired by Prof. Gurdip Singh and Co-chaired by Prof. C. B.
Bhuyan, Dr. Anup Thakar acted as the moderator of the session. 5 working groups could
complete their presentation by 07.00 PM, and then the house was dispersed with thanks to
chair and a note of reassembling at 09.00 AM on the third day.
Day 3: 30.11.2009; Monday
As per the scheduled plan, the different working groups met again at their
designated venue for 2 hours and made corrections in their work as per the suggestions
given by the house. The house reassembled in the seminar hall at 11.00 AM. The session
was chaired by Prof. R. R. Dwivedi, and Co-chaired by Prof. P. K. Prajapati, the session
moderator was Dr. Darshana Pandya. 5 working groups could complete their presentation
by 01.30 PM, and then the house was dispersed for lunch after thanks to chair and a note of
reassembling at 03.30 PM for continuation of presentation and discussion followed by
valedictory session.
The post lunch session was chaired by Dr. Dilip Gadgil and Co-chaired by Dr. K. S.
Patel, Dr. Galib was the moderator in this session. The general protocol developing group
presented the summary of their discussions in this session, Dr. Galib, coordinator of the
working group presented the gist of their discussions.
The subject opened for discussion by the chair and a healthy discussion took place
with some suggestions too. The session concluded with chairpersons remarks and thanks to
the chair.
The valedictory session started at 4.30 PM and Hon’ble Vice Chancellor and Director
of the Institute Prof. M. S. Baghel chaired the session. Dr. Nandini Kumar, Dr. Tanuja
Nesari, Dr. P. S. Shrivastav, Dr. A. R. Trivedi, Dr. M. M. Padhi and Dr. H. M. Chandola were
on the dais. All the dignitaries on the dais shared their views of this 3 days workshop and
suggested fruitful suggestions for successful completion of the task of developing guideline
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for clinical research in Ayurveda. From the participant’s side, Dr. Rama Jayasundar, Dr.
Bhavana Parashar, Dr. Anukul Chandra Kar, Dr. Gopakumar, Dr. Vasanth Patil, Dr. V. D.
Shukla presented their views on the workshop.
Chairman of the session, Prof. M. S. Baghel in his presidential address presented a
common research format developed by his team, which was placed before the General
Protocol development working group and as per decision of the group it will serve as CRF 1
which will be common for all clinical trials, the disease specific CRF 2 should be developed in
due course of time he added. More than 100 symptoms have been graded in the working
group meetings and it will be summarized and sent to all participants in due course of time
for consensus and he also appealed before the august gathering to give suggestions on this
CRF 1, it will be circulated among all institutions and research bodies for suggestions and in
the next phase of the work, the suggestions received will be reviewed by experts and
necessary modification will be made before final copy, he added. He thanked all the august
resource persons who have come from different parts of the country for the good cause of
Ayurveda and mankind.
The recommendations made by the general protocol working group which are to be
taken as final decisions of the workshop he added.
The recommendations made by the general protocol development working group
are:
• There is one paper on research methodology in M.D. (Ayu) curriculum contents of which
should be elaborated including basic research guidelines formed by WHO, ICMR & other
relevant good practices of Ayurveda (GMP etc.).
• Man power of Traditional Systems of Medicine (TSM) / Ayurveda should be
strengthened and trained in research methodology of concerned fields. Govt. of India
Dept. of AYUSH may initiate the intensive CME on Research Methodology for PG
Teachers, at least 3 CME in three years to all the teachers for recognition as PG
Teachers.
• Need of registering Ayurvedic clinical trials in CTRI (Clinical Trial Registry of India):
initially the clinical trials should be enrolled in the existing registry.
• The institutions and research organizations of India may be requested to enroll their
clinical trials under CTRI and inform regarding the output of the studies.
• AYUSH may create separate forum for registry of clinical trials as soon as possible.
• Recommendation on including parameters mentioned under QOL in every CRF with due
elaboration towards consideration on relevant modern parameters. While including
parameters of QOL physical, physiological, psychological and spiritual parameters should
be considered and well focused.
• Parameters for safety should be added in all CRFs respectively and parameters for
Dhatvagni and Jatharagni are to be exercised.
• The generic protocol which is finalized is to be circulated among the respective technical
people for providing inputs which will be incorporated into the final format. This will be
communicated to the selected institutions and research organizations in turn.
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• Basic clinical research format should have clearly two portions dealing with Rogi
Pariksha and Roga Pariksha.
• Besides the generic protocol, a specific protocol for each disease will be prepared. In
addition, a manual will be prepared based on these protocols for proper execution of
the project. It was also decided to form a working group of experts who will monitor the
progress of the work and refining of the prepared CRFs and also will do interim analysis
after pilot testing of the protocols, which is mandatory.
• After finalizing the standard formats and manuals, training sessions / training of the
trainers programes can be initiated with due permission of the concerned authority.
• It was also recommended to include a Bio statistician in future discussions on protocol
formation.
Dr. Rajagopala S, organizing secretary of the workshop conducted the session and
presented the Vote of Thanks.
All the invited participants were distributed with participation certificate.
The session ended at 06.00 PM, followed by a tea.
All the faculty members of IPGT&RA, postgraduate and Ph.D. scholars of the institute
participated actively in all the 3 days of the workshop.
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List of Participants attended the National Workshop on developing Guidelines for Clinical
Research Methodology in Ayurveda 28th to 30th November 2009
Resource persons – Outside
Prof. R. H. Singh
11.
Professor Emeritus, IMS, BHU, Varanasi.
Prof. Gurdip Singh
12.
Director (PG Studies), SDM College of Ayurveda, Hassan.
Dr. Rammanohar
13.
Director, AVATAR, Ayurveda Trust Campus, Coimbatore - 45
Dr. Gopakumar
14.
Asst. Professor, Dept. of Roga Nidana, Govt. Ayurveda College, Trivandurm.
Dr. Anukul Chandrakar
15.
Asso. Professor, Dept. of Roga Nidana, Faculty of Ayurveda, IMS, Varanasi.
Dr. Bhavna Palan
16. Scientist Fellow, Planning & Performance Division, CSIR, Anusandhan Bhawan,
2, Rafi Marg, NEW DELHI - 110001
Prof. Srinivas Acharya
17.
Professor, Dept. of Kayachikitsa, SDM College of Ayurveda, Udupi.
Dr. Manoj AK
18.
Asso. Professor, Dept. of Kayachikitsa, VPSV Ayurveda College, Kottakkal.
Dr. Dilip Gadgil
19.
Consultant Physician, Pune.
Dr. Rama Jayasundaram
20.
Asso. Professor, Dept. of Nuclear Medicine, AIIMS, Ansari Road, New Delhi
Prof. B. L. Mehra
21.
Professor, Dept. of Kayachikitsa, RGGPG Ayurveda College, Paprola. HP
Dr. P. K. Panda
22.
Reader, Dept. of Roga Nidana, Govt. Ayurveda College, Bolangir, Orissa
Dr. Nandini Kumar
23. Consultant, Division of Basic Medical Sciences, ICMR, Ansari Nagar,
NEW DELHI - 110029.
Dr. Supriya Bhalerao
24.
Dept. of Clinical Pharmacology, Nair Hospital, MUMBAI
Dr. Rama Chandra Bharadwaj
25.
Head, Clinical Research Division, FRLHT, Bangalore
Dr. Sulochana Bhat
26.
Asst. Director, CCRAS Head Quarters, Janakpuri, New Delhi.
Dr. PS Shrivastav
27.
Professor & Head, Dept. of Kayachikitsa, State Ayurveda College, Lucknow.
113
Dr. Bhimsen Behra
28.
Tech. Officer, Terminology Commission, Ministry of HR & D, New Delhi.
Dr. M. M. Padhi
29.
Joint Directro (Tech), CCRAS Head Quarters, Janakpuri, New Delhi.
Dr. Sonika Verma
30.
Basic Medical Sciences Division, ICMR Head Quarters, New Delhi
Dr. R. N. Tripathi
31.
Professor & Head, Dept. of Kayachikitsa, Govt. Ayurveda College, Raipur.
Dr. Haridra Dave
32. Professor & Head, Dept. of Shalakya, Govt. Akhandanada Ayurveda College,
Bhadra, Ahmedabad.
Dr. Vasanth Patil
33. Research Officer, SMRI (Ayurveda), Santhigiri Research Foundation, Santhigiri
Ashram P.O. TRIVANDRUM – 695 589
Dr. Tanuja Nesari
34.
Professor, Dept. of Dravyaguna, Tilak Ayurveda Mahavidyalaya, Pune.
Dr. M. Shrinivasulu
35. Professor & Head, Dept. of Kayachikitsa, BRKR Govt. Ayurveda College,
Hyderabad.
Dr. Pradeep Dua
36.
Research Officer, RRI, Gandhi Bhavan, Mandi. HP
Dr. Umesh Shukla
37. Professor & Head, Dept. of Kayachikitsa, Pt. KL Sharma Govt. Ayu College,
Bhopal
Dr. Manoj Nesri
38.
Joint Adviser – Ayurveda, Dept. of AYUSH, Ministry of Health & FW, New Delhi
Dr. Gaurav Sharma
39.
Research Officer, Dept. of AYUSH, Ministry of Health & FW, New Delhi
Dr. S. H. Acharya,
40. Reader & Head, Dept. of Panchakarma, SGA Mahavidyalaya, Guj. Ayurved
University, Jamnagar.
Dr. Girish Tillu,
41.
CDAC, Pune.
Prof. R. R. Dwivedi
42.
Professor & Head, Dept. of Basic Principles, IPGT&RA, Jamnagar.
Prof. H M. Chandola
43.
Dean, Professor & Head, Dept. of Kayachikitsa, IPGT&RA, Jamnagar.
114
Prof. V. D. Shukla
44.
Professor & Head, Dept. of Panchakarma, IPGT&RA, Jamnagar.
Prof. C. B. Bhuyan
45.
Professor & Head, Dept. of Shalya tantra, IPGT&RA, Jamnagar.
Prof. P. K. Prajapati
46.
Professor & Head, Dept. of Rasashastra, IPGT&RA, Jamnagar.
Prof. K. S. Dhman
47.
Professor & Head, Dept. of Shalakya tantra, IPGT&RA, Jamnagar.
Dr. T. N. Pandya
48.
Reader & Head, Dept. of Dravyaguna, IPGT&RA, Jamnagar.
Dr. K.S. Patel.
49.
Reader & Head, Dept. of Kaumarabhritya, IPGT&RA, Jamnagar.
Dr. L.P. Dei
50.
Reader & Head, Dept. of Striroga & PT, IPGT&RA, Jamnagar.
Dr. Manjusha R
51.
Reader, Dept. of Shalakya tantra, IPGT&RA, Jamnagar.
Dr. Anup B. Thakar
52.
Reader & Dept. of Panchakarma, IPGT&RA, Jamnagar.
Dr. A. R. Dave
53.
Reader, Dept. of Kayachikitsa, IPGT&RA, Jamnagar.
Dr. S. K. Gupta
54.
Reader, Dept. of Shalya tantra, IPGT&RA, Jamnagar.
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List of Teachers participated in the workshop: IPGT&RA
5 Dr. Galib , Asst. Professor, Dept. of Rasashastra & BK, IPGT&RA, Jamnagar.
9 Dr. Shilpa Donga, Asst. Professor, Dept. of Striroga & PT, IPGT&RA, Jamnagar.
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