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 RESEARCH METHODOLOGY
&
MEDICAL BIOSTATISTICS
FOR
(UNDERGRADUATE SCHOLARS OF AYURVEDA)
BY
DR DHULAPPA MEHATRE
M. D. (Ayu).
Reader and HOD
PG Studies in Dravya Guna
N K Jabshetty Ayurvedic Medical College and PG Center
Bidar, Karnataka
 ii Research Methodology and Medical Biostatistics

FOREWORD ders of us to show the mighty of Ayurveda by presenting through re-

search and statistical way for universal acceptance without a bias.
Revalidation has become an indispensable of the day to upbring
and update the old concepts to view them considering present day Author Dr. Dhulappa Mehatre is a good academician and an
science and to make it applicable to the needs and acceptance of present expert in handing over the knowledge in a lucid manner for students,
society. Research is nothing but careful and systematic work to seek teachers and for researchers alike. On perceiving the lack of light on
facts, information; it may be the renovation of the age-old concepts, the subject, he had made a good attempt through this book, with the
concept of “Visharayati leshoktam sankshiptyativistharam” for the
by scrutinizing them with statistical parameters of present era for ac-
benefit of Ayurvedic students avoiding confusion, to the extent needed
ceptance of present day scientific community and also for the safety
and welfare of the suffering mass. by UG student as well as PG scholars and research workers.

There are so many things we wish to know, which cannot be It has little to say of this art of communication, it takes great
observed by single observation or a single measurement. Hence to pass to make clear the use and limitations of each tool in simple way
to the extend concerned. This book is the product of a genuine teacher’s
establish a fact, we wish to envisage the behavior of a man who like all
experience and is exceptionally well adapted to the student’s use.
men is rather a variable quantity and must be observed repeatedly and
not once for all. We must be able to compare age group with another, I hope, his wish to enlighten the subject is done well, and the
once race with another or the effects of medicines in the individual same may be fulfilled by going through this book by the concerned.
with the norm for his age, race or class. All in all it certainly appears
that sound statistical sense are coming to be an essential of a liberal Hyderabad PROF. Dr. M. SRINIVASULU
education. Date: 23.11.2017 M.Sc.(Psy.), M.D (Ay.), Ph. D (N.I.A.)
Hence the knowledge of process of various research methods, P. G. Professor, N. K. Jabshetty
collection and presentation of the data available and presenting them Ayurvedic Medical College and P.G. Centre, Bidar
in a lucid manner after scrutiny by statistical parameters with valued (Former Head, P.G. Dept. of Panchakarma,
norms, is the need of the hour in the exploration and development of Govt. Ayurveda College, Hyderabad)
science.
More so in Ayurveda, it is a treasure of ancient knowledge
vvv
from prevedic period to the date, hence exploration is the need of the
day. Though it is an evidence based science since times immemorial,
which proved its efficacy from time to time and served the suffering
mass, it has become necessity to revalidate with innovative applica-
tions.
Now, it is the duty of us to focus and enlighten that wisdom to
the context of present society. Hence it has become a primary duty of
Ayurvedic physician and researcher to prove their eminence by bring-
ing the subject for the utility of the present day society. To make them
understand, we must present in their language, hence it is on the shoul-
 iv Research Methodology and Medical Biostatistics

FOREWORD generation Ayurveda teachers/clinicians to be well trained to get

succcess in treatment.
It gives me great pleasure to go through the book on Research
This book on Research Methodology and Medical Biostatis-
Methodology and Medical Biostatistics written by Dr. Dhulappa M.D.
tics by Dr. Dhulappa has elobarately dealt the subject in a lucid man-
(Ayur.) Asso. Professor of N. K. Jabshetty Ayurvedic Medical College
ner spreads over 12 chapters, high lighting the various facets of re-
& P. G. Centre, Bidar (Karnataka). He is known to me personally for
search methodology with related topics of statistics. He has put in lot
many years as a good teacher with academic bent of mind. He has
of efflorts and care in presenting all the relevant information.
earlier written a book on his own subject Dravyagun which is received
well by students community. I personally congratulate the author for his significant contribu-
tion in publishing this book and wish him all success in his endeavor
The present book on ‘Research Methodology and Medical Bio-
and hope many such useful books will come out from his vesratile pen
statistics’ written by the author is timely one, though there are many
in future for the benefit of students community.
books available on the subject, but this one proves to be beneficial to
the students community for better understanding of the subject, since With Blessings
it emphasis on conciseness and easy to comprehend style to cater to Bidar Prof. Dr. V. S. Patil
Karthika Poornima GCIM; M.D. (B.H.U.)
the needs of the fresh students of Ayurveda in gaining firm grip on this
4-11-2017 Medical Director,
very important subject of Research Methodology introduced recently
N.K. Jabshetty Ayurvedic Medical College
at under graduate level syllabus. and P. G. Centre, Bidar
Research Methodology is a continuously evolving subject, where Formerly, Principle/ Dean, Prof. & HOD
one needs to consult the current updates and modify the protocol and P. G. Dept. of Shalyatantra
formats as per the need from time to time. Research is essential for Govt. Ayur. Medical College Hyderabad.
development of any science, more so in respect of our ancient science
of life. Ayurveda, though is holistic in approach in diagnosis, progno- vvv
sis as well as management of diseases; Holistic approach has consider-
able difficulties and even challenges. The scientists have to devise pa-
rameters and design suitable models for clinical trials. The persuit of a
better understanding of the fundamental concepts and principles through
scientific research is the need of the hour. The quest of search for some-
thing new or reinvent the knowledge with the help of modern param-
eters for the betterment of mankind is called Research. It is highly
intellectual human activity used in the search of new knowledge. Since
active research indicates addition of new dimensions of appliations. It
is an endeavor of applications. It is an endeavor to discover new facts
or correlate old facts through new modern tools to get complete vali-
dated konwledge, in a methodial and systematic way. The aim of re-
search is also to consolidate fundamental knowledge and allow future
 vi Research Methodology and Medical Biostatistics

PREFACE & ACKNOWLEDGEMENT Mahaswamiji, the president of Shri Chidambar Sikshana Samsthe’s
N. K. Jabshetty Ayurvedic Medical College and PG center Bidar,
Quest of search for something new or reinvent the new knowl- Karnataka for his warm blessings.
edge for the betterment of mankind is as old as the human tradition
I would like to thank all management members, Principal and
and it is not new to the Ayurveda. It is already stated by our research-
Dean Prof Dr R. S. Sarashetty, N. K. Jabshetty Ayurvedic Medical
ers that “necessity is the mother of invention”. Ayurveda science is
College and PG Center Bidar for their support.
having treasure of knowledge like an ocean. As the advancement takes
place in science and technologies, it has created lot of scope to probe I am very much thankful to Prof Dr V. S. Patil, Medical Di-
the old sutras by taking help of advanced modern techniques into rector, former Principal and Dean of N K Jabshetty Ayurvedic Medi-
consideration for revalidation of old concepts in more effective way. cal and PG Center Bidar for his meticulous guidance and encourage-
ment to write and complete the book.
There are many book are available on Research Methodol-
ogy and Medical Biostatistics and these books are written by follow- I am thankful to Dr Channabasavanna B M, Reader and HOD
ing old syllabus for the benefit of post graduate scholars. As the new Dept. Panchakarma for his constant support and encouragement dur-
research methodology and medical biostatistics syllabus is introduced ing the completion of this book.
to undergraduate students, but no any such books are available for I am also thankful to Mr. Shashikant H Biostatistician BRIMS
same syllabus in one place. Hence it produces difficulty in under- Bidar, Dr M. Srinivasulu, Dr Bandeppa Sangolge, Dr Vijaykumar
standing the subject matter. For this, the undergraduate students need Biradar, Dr Chandrakant Halli, Dr Shailaja J R, Dr Sonali Phulasagar
to search available scattered subject matter in those books only. and all teaching faculties of N K Jabshetty Ayurvedic Medical Col-
So this book entitled with “Research Methodology and Medi- lege and PG center Bidar.
cal Biostatistics” is specifically compiled and written for the benefit I would like to thanks my parents, Smt Shakuntalabai, Shri
of undergraduate students of Ayurveda keeping in view the newly Dharmaji Mehatre for their blessings and support. I would also like to
framed syllabus (Revised scheme four) by C.C.I.M. Here I have tried thanks my mother in law Smt Bharatibai and father in law Shri Kondiba
to compile the matter by incorporating the views of both Ayurveda Suryavanshi for their blessings. I would like to thanks my wife Smt.
and Contemporary science along with suitable examples wherever Sunita Mehatre, Daughter Kum. Ashlesha Mehatre, Son Master Rachit
necessary. Mehatre, Brother in law Mr. Madhav Suryavanshi, Brother Mr. Santosh
This book consists two sections. Section A- Deals with fun- M and his wife Smt. Shubhangi M for their support during the work.
damentals of research such as definition of research, its types, literary I would like thanks the publishers, Mr. Surendra Kumar Gupta
research, different research designs, significance of ethical commit- and Mr. Arpit Gupta, Chaukhambha Prakashan, Varanasi for accept-
tee, data mining, bioinformatics and different methods of communi- ing to publish “Research Methodology and Medical Biostatistics for
cation of research trials in the form of research article, books etc. undergraduate scholar of Ayurveda”.
Section B- Deals with the knowledge of biostatistics used in assess-
ment of safety, efficacy and effectiveness of trials to draw the rel-
evant conclusions. It also deals with source of data, presentation of vvv
data and analysis of data by using different techniques, such as stan-
dard deviations, coefficient of variance, test of significance, etc.
I would like to thank His Holiness Shri Shri Shri Shivkumar
 ABBREVIATIONS
AÉ. AlÉÑ. mÉ. Ayurvediya anusandhana paddati
cÉ. xÉÇ. xÉÔ. Charaka Samhita Sootra Sthana
cÉ. xÉÇ. Charaka Samhita
cÉ. xÉÇ. ÌuÉ. Charaka Samhita Vimana Stana
iÉ. xÉÇ. Tarka Sangraha
xÉÑ. xÉÇ. xÉÔ. Sushruta Samhita sutra sthana
SQL Structured Query Language
ODBC Open Database Connectivity
JDBC Java Database Connectivity
CME Continuous Medical Education
ROTP Re-Orientation and Training Program
CDSCO Central Drugs Standard Control Organization
SOP Standard Operating Process
EC Ethical committee
NABH National accreditation board for Hospitals
IBM International Business Machines
CDC Centers for Disease Control and Prevention
SGI Saskatchewan Government Insurance
CRM Customer relationship management
Cms Centimeters
Kg Kilogram
PBCRs Population Based Cancer Registries.

vvv

viii
vii
 x Research Methodology and Medical Biostatistics

CONTENTS Chapter- V. RESEARCH TOOLS

Page No. a. Research tools. 52
i. Foreword i-iv b. Role of the pramanas as research tools. 52-80
ii. Preface and Acknowledgement v-vi Chapter- VI. ETHICS
iii. Abbreviations vii a. The concept and importance of ethics in research. 81-91
PART – A Chapter- VII. SCIENTIFIC WRITINGS
RESEARCH METHODOLOGY a. Concept of Evidence Based Medicine and Scientific
Chapter - I. HISTORY OF RESEARCH Writing. 92-95
1. Brief historical background of research in Ayurveda and Chapter- VIII. DATA MINING
contemporary medical science Evidences of researches in 1. Data mining 96
ayurvedic classics. 1-2 2. Evolutionary steps of data mining 96-97
2. Etymology, definitions and synonyms of the word Re- 3. Data mining techniques 97-98
search. 2-6 4. Five Major Elements in Data Mining 99
Chapter- II. SCOPE AND IMPORTANCE OF RESEARCH 7-10 5. Challenging Problems in Data Mining 99
1. Research in Ayurveda. 6. Application of Data Mining 99-100
2. Scope, need, importance, utility. 7. DATABASES & SOFTWARE 100-101
Chapter- III. TYPES OF RESEARCH 8. Important Research Data Portals Concerned With
a. Pure 11 Ayurved And Contemporary Medical Science 102
b. Applied 11-13 9. DHARA (Digital Helpline for Ayurveda Research
c. Qualitative, 13 Articles 102
d. Quantitative 14-15 10. PubMed, 102
e. Observational 15 11. Ayush Research Portal, 103
f. Interventional. 15-16 12. Bioinformatics Center, 104-110
g. Mixed 16-19 13. Research Management Informatics System 111-112
h. Other 19-25
Chapter- IV. RESEARCH PROCESS PART – B
a. Selection of the topic 26 MEDICAL-STATISTICS
b. Review of the literature 27-34 Chapter-IX
c. Formulation of Hypothesis 34-37 a. Definition of Medical statistics, 115-118
d. Aims and Objectives 37-39 b. Scope and importance of the Medical statistics 118-124
e. Materials and methods 39-46 c. Common statistical terms and notations
f. Observations and results 46-49 i. Population 125-126
g. Methods of communication of Research 49-51 ii. Sample 126-127
iii. Data 127-129
 Contents xi
iv. Variable 129
v. Normal distribution 129-130
Chapter - X
Collection and Presentation of data 130-133
a. Tabular 133-135
b. Graphical 135-139
c. Diagrammatical 140-143
Chapter - XI
Measures of Central Tendency/Average
a. Arithmetic mean 144-146
b. Median 146-147
c. Mode 147-148
Measures of location
Percentile 148-150
Chapter - XII
Variability and its measurement 151-153
a. Range 153-155
b. Standard deviation 155-156
c. Standard error 157-160
d. Introduction to probability and test of significance. 160-167
e. Parametric and non parametric tests. 168
f. Introduction to commonly used statistical
soft-wares. 168-169
· List of refrences 170

vvv

xii
 PART – A
RESEARCH METHODOLOGY

xiii xiv
 2 Research Methodology and Medical Biostatistics

CHAPTER- I in that field” i.e, one who carries different researches on the subject
HISTORY OF RESEARCH IN AYURVEDA will get more updated and valid knowledge. Similarly it is said that
the intelligent physician first diagnoses disease and later plans for the
INTRODUCTION: medicines, here Acharyas have given more importance to the exami-
Necessity is the mother of invention. This quest of searching nation of the diseases. It suggests that Ayurveda classics also given
something new or reinvent the knowledge for the betterment of man- more importance to Research Methodology.
kind is termed as Research. Research is as old as the human tradition The science that is practiced by the famous, successful, eminent
and it is not new to the Ayurveda. Ayurveda science is having treasure people, praised by the intellectual class is the best one. The quote is
of knowledge like an ocean. As the advancement takes place in sci- just an example pointing towards the high status of Ayurveda in an-
ence and it has created lot of scope to probe the old sutras by taking cient times, which is generally achieved only when research is an inte-
the help of advanced modern technologies into consideration. gral part of the science. Available literary sources of Ayurveda not only
Ayurveda classical texts are full of the direct and indirect ref- highlight the research attitude but also elaborate the methodology to
erences suggesting of research activity. First chapter of Charaka the minutest details.
samhita sutra sthana itself suggests the quest for longevity, which It is important to remember that research roots are indirectly
means search or the inquest, has been started for new ideas long back palpable in the text all the time. The difference is today methodology
only. Acharya Sushruta used the term “Bhootagram” to indicate ani- of research and statistics has become a consequential separate scien-
mals being used for testing the safety, efficacy and effectiveness of the tific branch associated with each respective segment of knowledge.
drug. Anusandhana, Anaveshana, Gaveshana, Pareeksha and Shodha ETYMOLOGY OF RESEARCH:
etc, synonymous words are used in different context in Ayurveda to
The term research is derived from French word “recherché”. This
show the significance of research.
is formed by the combination of two terms ‘Re’ and ‘Cherché’.
Research is highly intellectual human activity used in the in-
Re -Again, once more.
vestigation of new knowledge. It is an act of searching new idea or old
sutras under the shade of modern parameters. The gold standard to Cherché – Searching, examining, investigation.
judge the popularity and usefulness of any scientific branch is associ- Similarly the term research is also composed of two terms i.e.
ated with the ongoing research activities in that branch. This is be- Re- Again, once more.
cause active research indicates addition of new dimensions of appli- Search - An act of searching, examination.
cations, which in turn is a marker of liveliness and advanced approach Definition:
of the branch. Research in health sector is of the utmost importance i. Research is defined as scientific and systematic study of avail-
pertaining to the immediate application of the outcome to relieve hu- able information on a specific problem by formulating hy-
man beings from pain and agony. pothesis, suggesting possible solution, collecting, organiz-
Research is validation of knowledge with the help of modern ing; evaluating data to come to a conclusion by using ad-
parameters is started in ancient time and this is evidenced in Charaka vanced modern technology.
Samhita ii. Research is defined as an endeavor to discover new facts or
“Pareeksha karino hi kushala bahavati vaidya” || and correlate old facts through new modern tools to get com-
“Rogam adhya pareekshanam tadanantaram aushadham” || plete validate knowledge (Oxford Dictionary).
“Physician, who indulges in examination, will become expert iii. Research is defined as a scientific and highly intellectual
 CHAPTER- I 3 4 Research Methodology and Medical Biostatistics

human activity to study or investigation, examination in or- l. Search: Try to find out something by looking carefully and
der to establish facts and significance. thoroughly, investing deeply, examine thoroughly in order
Synonyms: to find something, hunt, check.
a. Probe. b. Quest. m. Validation: Check or prove the validity, authenticate, cer-
tify, legalize, authorize.
c. Search. d. Enquiry.
n. Verification: Make sure or show that something is true, con-
e. Investigation. f. Examination.
firm, substantiate, support.
g. Scrutiny. h. Verification.
Aim of research.
i. Establishing. j. Revelation. 1) To invent something new which is previously unknown
k. Discovery. l. Validation. through established means and methods
m.Revalidation. n. Re-establishing. 2) To find out truth in old sutra, concepts and practices.
Meaning of synonyms: 3) To throw light on old facts by modern means to revalidate
a. Discovery: An act of discovering, Detection, Innovation, Find them.
unexpectedly or in the course of search, become aware of, 4) To evaluate the effect of particular treatment, technique in
bring to light, perceive. order to improve the quality of therapy.
b. Enquiry: An act of asking for information. 5) To further improve the technique or instruments for easy ad-
ministration and rapid action.
c. Establishing: Action of establishing facts, Composition. Cre-
6) To assess the relative effectiveness of the health program in
ation, Formation, Setting up.
order to determine the allocation of resource in health set-
d. Examination: An act of detailed inspection, an formal test ting.
of knowledge or subject or skills.
Methodology:
e. Investigation: Carry out a systematic inquiry into incident
The term methodology is defined to be a systematic procedure
so as to establish truth, carry out research into subject. followed for carrying out trials either invitro or invivo to come to con-
f. Probe: An investigation, Examination, Go into, Inquire into, clusion.
Look into. 1. Definition of the term Anusandhana.
g. Quest: Long or difficult search, search for something which The term Anusandana is formed by the combination of two terms
is not existing previously. i.e.
h. Re-establishing: An act of forming the hypothesis once 1. Deveg - After, once again.
again. 2. mevOeeve - Searching, investigating, examining.
i. Revalidation: Examining the concept again. Definition:
j. Revelation: The reveling of something which is previously keâeÙe& keâejCe YeeJemÙe õJÙeeCeeb iegCekeâce&Cees:~
unknown, discovery, declaration, publication, exposure, un- heefj#Ùe mLeeheveb mecÙeievegmevOeevecegÛÙeles~~
masking. DevJes<eCe heÙex<eCeb ieJes<eCeceLeeefhe Ûe~
k. Scrutiny: Close and critical examination, analysis, exam- MeesOe FlÙeeefo heÙee&Ùes: ueeskesâ meceefYeOeerÙeles~~ Dee. Deveg. he.
ine, look closely. Anusandhana is defined as processes of establishing Karya
 CHAPTER- I 5 6 Research Methodology and Medical Biostatistics

Karana relation between the Guna and Karma of the Dravya after analy- Synonyms of Anusandhana:
sis with help advanced modern technique. DevJes<eCeb heÙex<eCeb ieJes<eCeceLeeefhe Ûe~
Dravya (Substance): MeesOe FlÙeefo heÙee&Ùes: ueeskesâ meceefYeOeerÙeles~~ Dee. Deveg. he.
Ùe$eeefßelee: keâce&iegCee: keâjCeb meceJeeÙe Ùeled~ leodõJÙeb........~~ Ûe.meb. met. 1. Acharya Prof. P. V. Sharma mentioned some of the synonymous
terms to denote anusandhana as anveshana, paryeshana, gaveshana
Dravya is defined as a substance which gives accommodation to
and shodha.
guna and karma.
According to Acharya Chakrapanidatta, guna term is used as
1. DevJes<eCe - It is formed by the combination of two words;
representative of Rasa, Guna, Veerya, Vipaka and Prabhava. Deveg- Once again.
iegCe Meyosve ÛewJe Oece& JeeefÛevee jme iegCe JeerÙe& efJeheekeâ ØeYeeJe meJe& SJeb «ee¢eles~~ S<eCe -Searching.
Ûe›eâheeefCe~~ Revalidation of concepts is called as Anveshana.
Ex – Tulasi is considered as dravya. It will act as asharaya to 2. heÙex<eCe- It is formed by the combination of two words;
guna and karma i.e. katu rasa, laghu ruksha guna, ushna veerya, katu
heefj- All around.
vipaka and act as jvaraghna.
S<eCe - Searching.
Guna (Physical properties):
Analysis of the concept from all angles is called as Paryeshana.
1. meceJeeÙeer leg efve§es„: keâejCeb iegCe:~ Ûe.meb.met. 1
3. ieJes<eCe - It is also formed by the combination of two words;
2. õJÙeeßeÙÙeiegCeJeeve mebÙeesieefJeYeeies<JekeâejCecevehesòeâe Fefle iegCeue#eCeced~~
Jew.o. De. 1 met. 16 ieJeeced - Cows.
3. efJeÕe ue#eCee: iegCee:~~ j.Jew. 1. met. 138. S<eCe - Searching.
Guna is defined as physical property present in a dravya with The act of searching knowledge in the samhita, as the shepherd
samavaya relation. It is devoid of cheshta and has asamavaya karana searches the missed cows in dense forest is called as Gaveshana.
for effects or action of the dravya. Acharya Nagarjuna stated that, 4. MeesLe - Investigation, examination, establishing the old sutra
guna as “vishwalakshana”, because it is not perceived by single indriya. or concepts with the help of new means is called as Shodha.
Acharya Charaka considered 41 gunas and classified as follows;
Apart from these synonymous terms, we will come across some
1. Sartha guna-Indriya artha- 5. other terms which are frequently used as synonyms in classics as;
2. Gurvadi gunas- 20. Anveshana - Knowing the unknown thing.
3. Adhyatma Gunas- 6. Eshana - Searching.
4. Paradia Gunas- 10. Manthana - Churning to know the facts
Karma (Drug action): Pareekshya - Examination, experimentation.
1. mebÙeesies Ûe efJeYeeies Ûe keâejCeb õJÙeceeefßeleced~ Parishodhana - Searching.
keâle&JÙemÙe ef›eâÙee keâce&, keâce& veevÙeeohes#eòes~~ Ûe.meb.met. 1/52 Rishi vachana - Searching without selfish motto.
Karma is defined as the factor which is responsible for associa- Vimarsha – Analysis.
tion (samyoga), disassociation (vibhaga) and present in a dravya with
Tatva Vimarsha - Critical analysis.
samavaya type of relation. It is an independent cause for completion
of karma. vvv
 8 Research Methodology and Medical Biostatistics

CHAPTER- II. practiced in its whole potential in India and abroad and allow Ayurveda
SCOPE AND NEED OF RESEARCH IN AYURVEDA to gain final recognition globally.
The present science – conscious and probing generation desires
INTRODUCTION: The Research is as old as the human tradi- scientific explanation for each and every thing that is happening around
tion and it is not new to the Ayurveda. As the advancement takes place the world. Ayurveda being an ancient science, formulated on scientific
in present era and it has created lot of scope to probe the old sutras by parameters available at that time. As other allied science started to
taking the help of advanced modern technologies into consideration. pour into the minds, reasoning and explanation started to occupy the
The transformation of Agnivesha tantra into Charaka Samhita driver’s seat. This created necessity of research in Ayurveda.
itself indicates the continuous and constant research going on in Following are priority areas where we need research in Ayurveda.
Ayurveda for its betterment. Also the numbers of drugs used for differ-
ent ailments of human beings are also increased from Veda to Samhita 1. To maintain positive health in healthy individuals:
and Nighantu; it indicates that research is an endless process. Now a 2. To eradicate diseases of diseased person:
day’s many research institutes throwing modern light on old sutras to Ayurveda, being a life science has described different patya
validate them in well known language called modern research tech- apatya, ahara, vihara and other treatment modalities to fulfill the aims
niques. of Ayurveda in systematic and scientific manner. Even though, invade
The research methodology of classics and contemporary science of new diseases into present era has created the necessity of constant
are differ at various levels which needs to be think about and the ac- research in Ayurveda.
ceptable solution be searched. There is lot of scope of research in 3. To know the fundamental principles of Ayurveda:
Ayurveda which is the need of the hour. The whole world is looking
For better and thorough understanding the fundamental concepts
towards the alternative systems of medicine as a possible remedy to
of Ayurveda to get success in treatment in purview of other developed
ever-increasing menace of the resistance against the antibiotics used
allied science by advanced parameters is need of the hour.
non – judiciously in the medical practice today. This expectation of
the ailing world can be met through a sincere and dedicated research Fundamental research will have to be done in the fields of
activity in the traditional and alternate systems of medicine like the Ayurvedic physiology, Ayurvedic pathology, pharmacology /Dravya
Ayurveda. Guna (fundamental and clinical), pharmaceuticals (including knowl-
edge about the right land for cultivation, the right place and conditions
1. IMPORTANCE AND UTILITY OF RESEARCH IN THE
for collection and storage of plants), etc. To study concept of
AYURVEDA:
panchamahabhoota, tridosha, saptadhatu, etc.
We don’t want to prove the validity of Ayurveda to its people, to
a. To study concept of Agni, Ama and its role in manifestation
its authorities and to its own scientific community, because it is a rec-
of disease and treatment.
ognized medical system here. The research required in India is with-
out any doubt fundamental research, in order to refresh and upgrade b. To study Prakruti and its role in susceptibility to diseases
the tremendous treasure of knowledge diluted through time and under and prognosis.
the British rule. This research will consolidate fundamental knowl- c. To study Diet therapy and its role in treatment of disease.
edge and allow future generations of Indian Ayurveda teachers to be 4. On the drug front:
well trained in order to transmit Ayurveda on a high level not only to
In ancient time there is no much controversy exists with re-
Indian but also to foreign students. This will assure Ayurveda to be
 CHAPTER- II 9 10 Research Methodology and Medical Biostatistics

spect to identification of drug, because our Acharyas, they are living lowing since ancient times as Acharya Charaka redacted Agnivesha
in the forest and accustomed with identification of drugs. As the ad- tantra and named as Charaka Samhita. Later it was revised by
vancement taken place in the time period, many drugs are get lost and Dridabala to fill the gap of missing chapter of Charaka Samhita.
some new drugs are inoculated into the existing literature of Ayurveda Acharya Vagbhatt also followed the same methodology to compile
with some different synonyms and vernacular names. That has pro- best subject matter from Charaka and Sushruta Samhita into Asthanga
duced widespread confusion right from identification of raw drug to Sangraha and Asthanga Hridaya.
standardization of finished product. Similarly we need to incorporate the advanced technologies in
In absence of standard methodology to identify, the accurate and Ayurveda for the easy administration of drug in safe, effective manner
authentic sample is not available to needy. This has created stumbling without losing its potency by modifying the form, consistency, ap-
block in the development of Ayurveda. It can be overcome only by the pearance, palatability and in most economical way to upgrade the clas-
evolution of systematic, scientific and standardized protocol of drug. sical method of treatment.
Hence we need to carry out research in Ayurveda by following way; 7. Acute medical care in Ayurveda:
a. Medico- botanical survey, identification, cultivation of me- It is universal truth that there is no definite acute medical care in
dicinal plant. Ayurveda, and it is single obstacle in the path of its desire develop-
b. Physico- chemical, Phyto chemical analysis. ment. Popularity of any science depends upon its ability to meet its
c. Pharmacological and toxicological study. demand in handling emergencies. But when we go through the refer-
ences of some drugs in Ayurveda which are predominated with vyavayi,
d. Preparation of standardized protocol of drug.
vikasi, teekshna, ashukari etc guna have ability to overcome the acute
5. Clinical trial: condition by producing its desired effect within short time will create
Ayurveda mentioned number of single drugs and aushadhi yogas hope for the search of new drug and formulation with easy bio-avail-
to treat single disease, the number increased because it advocates vyakti ability and cross blood brain barrier.
vishesha (individual) chikitsa. Among the list of single or compound 8. To improve drug delivery system in Ayurveda:
formulation, the more efficacious, safe and cost effective drugs, line
The management of acute and emergency condition is directly
of treatment has to determined by means of subjecting the drugs, line
proportional to drug delivery system. The fundamental principle of
of treat to patients in clinical trials as follows;
Pharmacy states that “smaller the particle, greater the absorption and
a. Clinical trials of selected single herbal preparation and herbo- faster the action”. In Ayurveda Rasa aushadhis and Bhasma fulfill this
mineral preparation. criterion for certain extent. But its need of hour to improve drug deliv-
b. To determine the efficacy of line of treatment by clinical ery system in Ayurveda by bringing certain changes in the method of
means. preparation of formulations, its sahapana and anupana according to
c. Survey and identification of priority area in clinical trials. the assessment of balabala of roga and rogi.
6. Updating Ayurveda: Example: Preparation of Amalaki rasayana by using its own
swarasa to enhance its potency. Another examples are Amritikarana,
Any subject in this universe requires constant revision of sub-
Sukshmikarana, Chausasthi pippali etc are mentioned in classics to
ject matter, to acclimatize with advanced scientific methodology and
improve drug delivery system.
technique used for the benefit of needy. Such incidents are also fol-
vvv
 12 Research Methodology and Medical Biostatistics

CHAPTER- III. 4. This research is generally conducted on a large scale basis

TYPES OF RESEARCH and is expensive. As such, it is often conducted with the sup-
port of some financing agency like the National government,
INTRODUCTION: Public corporation, World Bank, UNICEF, UGC, Etc.
Research can be classified into many different ways on the basis 5. Applied research is an investigation for ways of using scien-
of the methodology of research, the knowledge it creates, the user tific knowledge to solve practical problems. For example:
group and the research problem it investigates; Treat or cure a specific disease, and suggests new line of
A. Pure Research: treatment for the problem.
Pure research is defined as a type of scientific research, mainly Applied research can be further classified as;
aimed to improve scientific theories for improved understanding or a. Problem oriented research.
prediction of natural or other phenomena for the benefit of human b. Problem solving research.
being. It is also called as basic research or fundamental research.
a. Problem oriented research: This type of research is done
Example: Understanding the tridosha or panchamhabhoota
by industry apex body or organization for sorting out prob-
siddhanta.
lems faced by all the companies or organizations.
Characteristics:
Importance:
1. The main motivation here is to expand man’s knowledge, not
i. Problem identifying researches are undertaken to know the
to create or invent something.
exact nature of problem that is required to be solved.
2. This research is conducted largely for the enhancement of
knowledge and which does not have immediate commercial ii. Here, when we use the term ‘Problem’, it is not a problem in
true sense. It is usually a decision making dilemma or it is a
potential. Such a research is time and cost intensive. Ex-
need to tackle a particular business situation.
ample: An experimental research that may not be or will be
helpful in the human progress. iii. It could be a difficulty or an opportunity.
B. Applied Research: Example: Failure in results of treatment may be assessed by means of
Applied research is defined as a type of research, which uses any one of the following:
scientific theories to develop technology or techniques to intervene · Not so thoroughly examined the patient or medicine.
and alter natural or other phenomena. · Poor quality of the product.
Characteristics: · Lack of continuous follow up and availability of medicine.
1. Applied research is designed to solve practical problems of · High price of medicine and line of treatment.
the modern world, rather than acquire knowledge for b. Problem solving research: This type of research is done by
knowledge’s sake. an individual company or organization or institute for the
2. The goal of applied research is to improve the human condi- problem faced by it. In short, the main aim of problem solv-
tion. ing research is to discover some solution for some urgent
3. It focuses on analysis and solving social and real life prob- practical problem.
lems.
 PART – B
MEDICAL STATISTICS

113 114
 116 Research Methodology and Medical Biostatistics

CHAPTER-IX b. Definition of Medical statistics: Medical Statistic is a type

INTRODUCTION TO MEDICAL STATISTICS of Statistics. “It deals with summarizing, collecting, presenting and
interpreting data in medical practice, and using them to estimate the
Introduction: In the modern world of computers and informa- magnitude of associations and test hypotheses.
tion technology, the importance of statistics is very well recognized According to A. L. Bowley: Statistics are numerical statement of
by all the disciplines. Statistics has originated as a science of state- facts in any department of enquiry placed in relation to each other.
hood and found applications slowly and steadily in Agriculture, Eco- A.L. Bowley Statistics may be called the science of counting in
nomics, Commerce, Biology, Medicine, Industry, planning, education one of the departments, obviously this is an incomplete definition as it
and so on. Also, there is no human walk of life, where statistics cannot
takes into account only the aspect of collection and ignores other as-
be applied.
pects such as analysis, presentation and interpretation. Bowley gives
Origin and Growth of Statistics: The word ‘Statistics’ and ‘Sta- another definition for statistics, which states ‘statistics may be rightly
tistical’ are all derived from the Latin word Status, means a political called the scheme of averages’. This definition is also incomplete, as
state. The theory of statistics as a distinct branch of scientific method averages play an important role in understanding and comparing data
is of comparatively recent growth. Research particularly into the math- and statistics provide more measures.
ematical theory of statistics is rapidly proceeding and fresh discover-
According to Croxton and Cowden: Statistics may be defined
ies are being made all over the world.
as the science of collection, presentation analysis and interpretation of
Meaning of Statistics: Statistics is concerned with scientific numerical data from the logical analysis. It is clear that the definition
methods for collecting, organizing, summarizing, presenting and ana-
of statistics by Croxton and Cowden is the most scientific and realistic
lyzing data as well as deriving valid conclusions and making reason-
one.
able decisions on the basis of this analysis. Statistics is concerned with
According to this definition there are four stages:
the systematic collection of numerical data and its interpretation. The
word ‘statistic’ is used to refer to numerical facts, such as the number a. Collection of Data: It is the first step and this is the founda-
of people living in particular area. tion upon which the entire data set dependence. Careful planning is
Definition of Statistics: Statistics is defines as branch which essential before collecting the data. There are different methods of
describes the measured facts or counted information or piece informa- collection of data such as census, sampling, primary, secondary, etc.,
tion in form of figures. and the investigator should make use of correct method.
Example: b. Presentation of data: The mass data collected should be pre-
sented in a suitable, concise form for further analysis. The collected
§ Height of persons in centimeters.
data may be presented in the form of tabular or diagrammatic or graphic
§ Weight of person in kilogram. form.
a. Definition of medical Biostatistics: Medical Biostatics is the c. Analysis of data: The data presented should be carefully ana-
term used when tools of statistics are applied to the data that is derived lyzed for making inference from the presented data such as measures
from biological science such as medicines is called as biostatistics or of central tendencies, dispersion, correlation, regression etc.,
medical biostatistics. It is also called as quantitative medicine, because
d. Interpretation of data: The final step is drawing conclusion
the diagnosis, treatment depends on counting number of dosha,
from the data collected. A valid conclusion must be drawn on the basis
dushyas, Agni, srotus etc involved in the manifestation of disease, dif-
of analysis. A high degree of skill and experience is necessary for the
ferent cells count, blood pressure, body temperature and pulse rate.
interpretation.
 CHAPTER- IX 117 118 Research Methodology and Medical Biostatistics

Definition by Horace Secrist: Statistics may be defined as the 4. Estimation: One of the main objectives of statistics is drawn
aggregate of facts affected to a marked extent by multiplicity of causes, inference about a population from the analysis for the sample drawn
numerically expressed, enumerated or estimated according to a rea- from that population. The four major branches of statistical inference
sonable standard of accuracy, collected in a systematic manner for a are;
predetermined purpose and placed in relation to each other. · Estimation theory.
Functions of Statistics: There are many functions of statistics. Let us · Tests of Hypothesis.
consider the following five important functions. · Non Parametric tests.
1. Condensation: Generally speaking by the word ‘to condense’, · Sequential analysis:
we mean to reduce or to lessen. Condensation is mainly applied at In estimation theory, we estimate the unknown value of the
embracing the understanding of a huge mass of data by providing only population parameter based on the sample observations. Suppose we
few observations. If in a particular class only marks in an examination are given a sample of heights of hundred students in a school, based
are given, no purpose will be served. Instead if we are given the aver- upon the heights of these 100 students, it is possible to estimate the
age mark in that particular examination, definitely it serves the better average height of all students in that school.
purpose. Similarly the range of marks is also another measure of the 5. Tests of Hypothesis: A statistical hypothesis is some state-
data. Thus, Statistical measures help to reduce the complexity of the ment about the probability distribution, characterizing a population
data and consequently to understand any huge mass of data. on the basis of the information available from the sample observa-
2. Comparison: Classification and tabulation are the two meth- tions. In the formulation and testing of hypothesis, statistical methods
ods that are used to condense the data. They help us to compare data are extremely useful. Whether crop yield has increased because of the
collected from different sources. Grand totals, measures of central ten- use of new fertilizer or whether the new medicine is effective in elimi-
dency measures of dispersion, graphs and diagrams, coefficient of nating a particular disease are some examples of statements of hy-
correlation etc provide ample scope for comparison. If we have one pothesis and these are tested by proper statistical tools.
group of data, we can compare within it. If the rice production (in e. Scope and importance of the Medical statistics:
Tones) in Tanjore district is known, then we can compare one region Scope: Statistics is not a mere device for collecting numerical
with another region within the district. Or if the rice production (in data, but as a means of developing sound techniques for their han-
Tones) of two different districts within Tamil Nadu is known, then dling, analyzing and drawing valid inferences from them. Statistics is
also a comparative study can be made. As statistics is an aggregate of applied in every sphere of human activity social as well as physical
facts and figures, comparison is always possible and in fact compari- like Biology, Commerce, Education, Planning, Business Management,
son helps us to understand the data in a better way. Information Technology, etc. It is almost impossible to find a single
department of human activity where statistics cannot be applied. We
3. Forecasting: By the word forecasting, we mean to predict or
now discuss briefly the applications of statistics in other disciplines.
to estimate beforehand. Given the data of the last ten years connected
i. Statistics and Medicine: In Medical sciences, statistical tools
to rainfall of a particular district, it is possible to predict or forecast
are widely used. In order to test the efficiency of a new drug
the rainfall for the near future. In business also forecasting plays a
or medicine, t - test is used or to compare the efficiency of
dominant role in connection with production, sales, profits etc. The
two drugs or two medicines, ‘t’test for the two samples is
analysis of time series and regression analysis plays an important role
used. More and more applications of statistics are used in
in forecasting. clinical investigation.
 CHAPTER- IX 119 120 Research Methodology and Medical Biostatistics

ii. Statistics and Ayurveda: There is lot of scope for statistics in plots are given. In such a situation, we are interested in find-
Ayurveda, because every concept has its own parameters and ing out whether the effect of these fertilizers on the yield is
it is expressed in the form of qualitative data. To convert them significantly different or not. In other words, whether the
into some measurable data or facts to come to conclusion, samples are drawn from the same normal population or not.
where the said line of treatment is efficacious or not etc there The answer to this problem is provided by the technique of
need of statistics in Ayurveda. ANOVA and it is used to test the homogeneity of several
iii. Statistics and industry: Statistics is widely used in many in- population means.
dustries. In industries, control charts are widely used to main- vi. Statistics and Economics: Statistical methods are useful in
tain a certain quality level. In production engineering, to find measuring numerical changes in complex groups and inter-
whether the product is conforming to specifications or not, preting collective phenomenon. Nowadays the uses of statis-
statistical tools, namely inspection plans, control charts, etc., tics are abundantly made in any economic study. Both in eco-
are of extreme importance. In inspection plans we have to nomic theory and practice, statistical methods play an impor-
resort to some kind of sampling – a very important aspect of tant role. Alfred Marshall said, “Statistics are the straw only
Statistics. which I like every other economist has to make the bricks”. It
iv. Statistics and Commerce: Statistics are lifeblood of suc- may also be noted that statistical data and techniques of sta-
cessful commerce. Any businessman cannot afford to either tistical tools are immensely useful in solving many economic
by under stocking or having overstock of his goods. In the problems such as wages, prices, production, distribution of
beginning he estimates the demand for his goods and then income and wealth and so on. Statistical tools like Index num-
takes steps to adjust with his output or purchases. Thus sta- bers, time series Analysis, Estimation theory, Testing Statis-
tistics is indispensable in business and commerce. As so many tical Hypothesis are extensively used in economics.
multinational companies have invaded into our Indian vii.Statistics and Education: Statistics is widely used in educa-
economy, the size and volume of business is increasing. On tion. Research has become a common feature in all branches
one side the stiff competition is increasing whereas on the of activities. Statistics is necessary for the formulation of
other side the tastes are changing and new fashions are emerg- policies to start new course, consideration of facilities avail-
ing. In this connection, market survey plays an important role able for new courses etc. There are many people engaged in
to exhibit the present conditions and to forecast the likely research work to test the past knowledge and evolve new
changes in future. knowledge. These are possible only through statistics.
v. Statistics and Agriculture: Analysis of variance (ANOVA) viii. Statistics and Planning: Statistics is indispensable in plan-
is one of the statistical tools developed by Professor R.A. ning. In the modern world, which can be termed as the “world
Fisher, plays a prominent role in agriculture experiments. In of planning”, almost all the organizations in the government
tests of significance based on small samples, it can be shown are seeking the help of planning for efficient working, for the
that statistics is adequate to test the significant difference formulation of policy decisions and execution of the same.
between two sample means. In analysis of variance, we are In order to achieve the above goals, the statistical data relat-
concerned with the testing of equality of several population ing to production, consumption, demand, supply, prices, in-
means. For an example, five fertilizers are applied to five vestments, income expenditure etc and various advanced sta-
plots each of wheat and the yields of wheat on each of the tistical techniques for processing, analyzing and interpreting
 CHAPTER- IX 121 122 Research Methodology and Medical Biostatistics

such complex data are of importance. In India statistics play 120

an important role in planning, commissioning both at the cen- For example: Average normal blood pressure is mmHg, ,
80
tral and state government levels. but up to what limits it may be considered as normal on ei-
ix. Statistics and Modern applications: Recent developments ther side of average is to determined.
in the fields of computer technology and information tech- 2. To find out the difference between mean and proportions of
nology have enabled statistics to integrate their models and normal at two places or in different periods.
thus make statistics a part of decision making procedures of For example: The mean yield of plants grown in Karnataka
many organizations. There are so many software packages is less compare to the mean yield of plant grown in Himalaya.
available for solving design of experiments, forecasting simu- The average presence of active components in the sheeta
lation problems etc. SYSTAT, a software package offers mere veerya dravya is less in any temperate region compares to
scientific and technical graphing options than any other desk- mean of active components in cold region of India.
top statistics package. SYSTAT supports all types of scien-
3. To find out correlation between two variables, such as effects
tific and technical research in various diversified fields as
of Rasa (Taste madhura, amla etc) on dosha (body humors
follows;
as vata, pitta and kapha), snehana karma on vataja vikara,
1. Archeology: Evolution of skull dimensions. Atilanghana with vataja vikara, Vyavaya with Rajayakshma.
2. Epidemiology: Tuberculosis. B. In Pharmacology:
3. Statistics: Theoretical distributions. 1. To find the action of drug.
4. Manufacturing: Quality improvement. For example: After administration of drug to animals or hu-
5. Medical research: Clinical investigations. man beings, it brings certain changes the body, finding out
6. Geology: Estimation of Uranium reserves from ground change by virtue of drug or some other local factors.
water 2. To compare the action of two drugs or two line of treatments
x. Statistics and planning: Statistics is essential for planning or two successive dosage of same drug.
in the modern era. It is termed as “the age of planning”. For example: After administration of two different drugs or
xi. Statistics and war: In war the theory of decision function line of treatment or dosage of same drug to selected groups
can be a great assistance to the military and personal to plan over a time period, the efficacy is determined by comparing
“maximum destruction with minimum effort.” the effect of drug on selected parameters.
IMPORTANCE OF THE MEDICAL STATISTICS: 3. To find the relative potency of new drug with known stan-
Application and uses of biostatics as a science: dard drug.
A. In Physiology and anatomy: For example: Take a new unknown drug and evaluate the
1. To define what is normal or healthy in a population and to efficacy of this in comparison with known standard drug.
find out the limits of normality in variables such as height, C. In Medicine:
weight, pulse rate, blood pressure, lakshanas of dosha, dushya 1. To compare the efficacy of a particular drug, operation or
in samya avastaha and to differentiate it from vruddhi and line of treatment, for this – the percentage cured, relieved or
kshaya conditions. died in experiment and control group.
2. To find an association between two attributes, for example –
 CHAPTER- IX 123 124 Research Methodology and Medical Biostatistics

Mrudbhakshana and Pandu, Smoking and cancer, filariasis 3. Statistical laws are not exact: It is well known that math-
and socio-economical status. ematical and physical sciences are exact. But statistical laws are not
3. To identify signs and symptoms of a disease or syndrome. exact and statistical laws are only approximations. Statistical conclu-
For example: Je=ef#ekeâ obMeJeled Jesovee in Jeelejòeâ (Gout) and cegef<ekeâ sions are not universally true. They are true only on an average.
obMeleJed Jesovee in DeeceJeele (Rheumatoid arthritis). Dhanushakara 4. Statistics table may be misused: Statistics must be used only
(arched) body in Kupeelu visha (Strychnus poison). Cough by experts; otherwise, statistical methods are the most dangerous tools
in typhoid is by chance and fever is found in almost cases. on the hands of the inexpert. The use of statistical tools by the inexpe-
rienced and untraced persons might lead to wrong conclusions. Statis-
D. In Community Medicine and public health:
tics can be easily misused by quoting wrong figures of data. As king
1. To test usefulness of sera and vaccination in field studies.
says aptly ‘statistics are like clay of which one can make a god or devil
Example: percentage of attacks and death between vaccinated
as one pleases’.
and non vaccinated subjects is evaluated to see the signifi-
5. Statistics is only, one of the methods of studying a prob-
cance of program.
lem: statistical methods do not provide complete solution of the prob-
2. In epidemiological study: The role of causative factor is sta- lems, because problems are to be studied taking the background of the
tistically tested. Example: Deficiency of iodine and goiter, countries culture, philosophy or religion into consideration. Thus the
asyasukha and prameha, virudha ahara and kustha, statistical study should be supplemented by other evidences.
agnimandhya and atisara.
Limitations of statistics: vvv
Statistics with all its wide application in every sphere of human
activity has its own limitations. Some of them are given below.
1. Statistics is not suitable to the study of qualitative phe-
nomenon: Since statistics is basically a science and deals with a set of
numerical data, it is applicable to the study of only these subjects of
enquiry, which can be expressed in terms of quantitative measurements.
As a matter of fact, qualitative phenomenon like honesty, poverty,
beauty, intelligence etc, cannot be expressed numerically and any sta-
tistical analysis cannot be directly applied on this qualitative phenom-
enon. Nevertheless, statistical techniques may be applied indirectly
by first reducing the qualitative expressions to accurate quantitative
terms. For example, the intelligence of a group of students can be
studied on the basis of their marks in a particular examination.
2. Statistics does not study individuals: Statistics does not give
any specific importance to the individual items; in fact it deals with an
aggregate of objects. Individual items, when they are taken individu-
ally do not constitute any statistical data and do not serve any purpose
for any statistical enquiry.