PROFORMA

DEPARTMENT OF PRASUTI TANTRA

FACULTY OF AYURVEDA
INSTITUTE OF MEDICAL SCIENCES
BANARAS HINDU UNIVERSITY VARANASI 221005

TOPIC – "Role of Palashakshara in management of Garbhashaya grivagata vrana

(cervical erosion)

Date ofregistration:
Date ofCompletion:

Name ofMDscholar: Dr. Pragati Saxena

S.NO. :

Drop out fromtrial:

Reason for drop out from the study (if any):

OPD No./MRD No:

Ward/Bed No. :
Name of the Patient:
Husband's/Father’sName:
Age: Yrs.
Religion: Hindu Muslim Christian Others
Habitat: Urban Semi-urban Rural

Address & Phone No: …………………………………………………….

EducationalStatus: Illiterate Primary Higher
Occupation: Housewife Working Student
Husband’s/Father’sOccupation: Unemployed Service Business

Socio –economicStatus: Upper Middle Lower

Chief Complaints withDuration:
1. Yonisrava (Vaginal discharge)
2. Katishool (Low backache)
3. Udarshula (Pelvic pain)
4. Antararituraktasrava (Intermenstrual bleeding)
5. Maithunaasahiushnuta (Dyspareunia)
6. Maithunapaschatraktasrava (Post coital bleeding)

Associated Complaints ifany:

History of Present Illness:

History of Past Illness:

MedicalHistory:

SurgicalHistory:

Blood Transfusion History:

Drug History & any Allergy History:

Family History:

Personal History:

Psychologicalstatus:Normal Anxious Depressed

DietaryHabits: Atiruksha Atisnigdha

SamanyaVegetarian

NonVegetarian

RasaSevana(In excess) :Madhur Amla Lavana

Katu Tikta Kashaya

Appetite: Good Average Poor

DigestivePower: Good Average Poor

Addiction: Yes No

If Yes, Type of Addiction:

Smoking Tobacco Alcohol Others

BowelHabits: Regular Irregular Constipated

LooseStool times/day

Micturition: Normal Sleep: Condition:Good

Burning
Hygienic
Decreased Painful Altered Increased Poor
Average

Gynecological and obstetrical History-

Menstrual History:
L.M.P : Age ofMenarche :

Menstruation Present Menstrual history Past Menstrual history

Duration (days)
Interval (days)
Amount(scanty/moderate
excessive)
Regular/Irregular
Color
Stain incloth remains
after washing

MarriedLife: Years
ActiveMarried Life Years

Other vaginal discharge:

History of Contraception :Safe method/Intra Uterine Contraceptive Devices (IUCD) /
Barrier method
Obstetric History:
Gravida:
Parity :
Abortion:Spontaneous Medical termination of Pregnancy(MTP)

Still Birth :
IUD:
Live Birth:
Mode of Delivery of Previous Pregnancies:
Last Delivery:

Astavidha Pariksha:

Nadi
 Mutra
Mala
Jihva
Sabda
Sparsh
Drik
Aakriti
Dashvidha Pariksha :

1. Prakriti:

Deha Prakriti– Vatika Paitika Kaphaja

Vata-Paitika Vata-Kaphaja Pitta-

KaphajaSannipataja

ManasPrakriti– Satvika Rajasika Tamasika

2. Vikriti
3. Saara Rasa Rakta Mamsa
MedaAsthi Majja Shukra

4. Samhanana Krisha Madhyama Sthoola

5. Pramana Pravara Madhyama Avara
6. Satmya Pravara Madhyama Avara
7. Sattva Pravara Madhyama Avara
8. Aharashakti

AbhyavharanaShakti Pravara Madhyama Avara

JaranaShakti Pravara Madhyama Avara
9. Vyayamashakti Pravara Madhyama Avara

10. Vaya (20 – 40yrs)

Patients Condition at the Time of Registration:

General Condition: Good Average Poor

Nutritional status : Undernourished Moderate nourished well nourished

Height: cm
Weight: kg
 Built: Obese Average Thin
Pallor: Absent Present
Icterus: Absent Present
Oedema: Absent Present

+ + Tongue: + Pink Pale Bluish

+ + + Moist Dry Coated

+ Uncoated / Clean

+ Clubbing: Present Absent

Cyanosis: Present Absent

Lymphadenopathy: Present Absent

Temperature (0F):
Pulse (Per Minute):

Respiratory Rate (Per Minute):

Blood Pressure (mm of Hg):
Systemic Examination:

Central Nervous System:

Respiratory System:
Cardiovascular System:
Gastro – Intestinal System:

Genitourinary System:

Per abdominal examination:

1. Inspection
2. Palpation:

3. Auscultation
4. Percussion
 External Genitalia appearance: Normal Inflammed

Oedema With lesions

If any previouslesionpresent: Episiotomyscar Perineal tear

INVESTIGATIONS
Routine investigation
1.CBC
2.Blood Sugar:
3.HIV 1 & 2:
4.HBsAg:
5.VDRL:
6.Urine Routine & Microscopy:
Special Investigation:

1. PAP smear

2. HVS

3. Vaginal and cervical pH

TREATMENT

Follow ups
Total
Duration of Without medication
Drug Dose Route Time of study
administration including 1st 2nd follow
follow ups follow up (21st
up (14th day)
day)
Palashaksha As per Per 1st sitting- Early 21 days
ra requirement vaginal morning oncea
application day on Day 0
followed by
Ghritakumar 2nd sitting- Early
ipichudhara morning once a
n day on Day 7th
 FOLLOWUP
Assessment criteria On 1st sitting On 2nd sitting Without treatment
Subjective and Objective criteria Day 0 Day 7th 1st 2nd
Follow Follow
up day up day
14th 21st
 Yonisrava(Vaginal discharge)

 Katishoola(Low back pain)

 Udarshula(chronic Pelvic pain)
 Maithunaasahiushnuta(Dyspareunia)

 Maithunapashchatraktasrava(Post coital
bleeding)

 Antra-rituraktasrava(Intermenstrual
bleeding)

 Area of erosion

 Appearance of erosion

 Cervical motion tenderness

Assessment criteria On 1st sitting On 2nd sitting Without treatment

Subjective and Objective criteria Day 0 Day 7th 1st 2nd
Follow Follow
up day up day
14th 21st
Vranaropana (wound healing) property

Vedana (Pain)
Daha(burning sensation)
Kandu(itching)
Srava (Discharge)
Gandha (smell)
Akruti(Floor and Granulation tissue)
Vranaropana (wound healing) property
Lab investigation Before After
treatment treatment
0 day 28th day
PAP smear
HVS-CS
Cervical and vaginal
pH
Criteria for scoring:-
On the basis of subjective criteria:-

Gradin Scorin Yonisrava(Vagi Katishoola(Lo Udarshula(Pel Maithunasahiushnuta(Dyspareu

g g nal discharge) w backache) vic pain) nia)

Normal 0 Normal No backache No abdominal Absence of Dyspareunia

physiological pain
without spotting
undergarments
and certain
moistening from
vulva and vagina

Mild 1 Moderate Intermittent Mild pain Pain during forceful coitus

discharge and backache, throughout the
causing spotting relieved by day but relieved
1-2 inch in rest by rest
undergarments,
once or twice
daily.

Moderat 2 Undergarments Backache Pain interfering Patient tries to avoid marital

e are undeniably during efforts physical relation due to pain during coitus
soiled and and forward activity and not
require changing bending, relieved by rest
and washing one relieved by
times daily. rest

Severe 3 Undergarments Constant pain, Pain interfering Severe pain even on light touch
are undeniably relieved by physical
soiled and taking activity and
require changing analgesics relieved by
and washing 2-3 taking
times daily. analgesics

Scoring Maithunapashchatraktasrava(Pos Antra-

t coital bleeding) rituraktasrava(Intermenstrual
bleeding)

0 Absent Absent

1 Present Present

On the basis of objective criteria:-

Area of erosion- Upper lip-50%, Lower lip 50%, Right lateral lip 25%, Left lateral lip 25%

0 0-25%
1 26-50%
2 51-75%
3 >75%

Appearance of erosion-

0 White colour/ Normal tissue/ No discharge

1 Pink/ Granulation tissue complete/ Slight discharge
2 Red/ No granulation/ Moderate discharge
3 Deep red/ No granulation/ Cervix embedded in discharge

Cervical motion tenderness-

0 Absent
1 On compression and rubbing with swabs
2 Without compression
3 Severe

Vranaropana(Wound healing) properties:

Vedana (pain)-

Grading Symptoms
0 No pain
1 Pain during movement but tolerable
2 Pain during movement which affects the movement
3 Pain even during rest but not disturbing the sleep
4 Continuous feeling of pain disturbing the sleep

Daha(burning sensation)-

Grading Symptoms
0 No burning
1 Little, localised burning
2 Moderate localized burning
3 More localized burning
4 Continuous burning

Kandu(itching)-

Grading Symptoms
0 No itching
1 Slight itching
2 Moderate itching
3 More than moderate itching
4 Continuous itching

Srava(Discharge)-

Grading Symptoms
0 No discharge
1 Gauze slight moist
 2 Gauze completely wet
3 Moist completely within 24hrs

Gandha(smell)-

Grading Symptoms
0 No smell
1 Minimum bad smell
2 Moderate bad smell
3 Unpleasant
4 Foul smell

Akruti(Floor and granulation tissue)-

Grading Symptoms
0 Smooth, regular floor and with healthy granulation tissue
1 Smooth regular floor, slight discharge, with absence of slough
2 Smooth, irregular slight discharge, less granulation tissue and presence of slough
3 Rough floor and presence of slough with moderate quantity of discharge
4 Rough, irregular floor with more slough and profuse discharge.

Status of investigative parameters:-

Changes in PAP smear test-

Scoring Grading PAP smear (before and after treatment)

0 Absent Non-inflammatory
1 Present Inflammatory

HVS- Culture and sensitivity test (Nugent scoring system)–

Scoring Lactobacillus Gardenerellamorphotyp Curved bacteria
morphotype per e per field (mobiluncus)
field per field
0 >30 0 0
1 5-30 <1 1-5
2 1-4 1-4 >5
3 <1 5-30 5-30
4 0 >30 >30

Cervical and Vaginal pH-

Scorin Grading
g
  0 4 to <5
  1 5 to <6
  2 6 to 7
  3 More than 7

Criteria for assessment of total effect of treatment-

S.N. Total effect of treatment Relief in sign and symptoms

1. No change < 25%

2. Improvement 26-50%

3. Markedly improvement 51-75%

4. Cured 76-100%

RESULT : Cured/ Improved/Partially improved/Unchanged

Signatureofstudent Signature of supervisor

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 CONSENT TO PARTICIPATE IN RESEARCH STUDY
A) Patient information sheet

The purpose of this consent form is to help you with the information, in taking
decision whether to participate in this research study.
Study title:
“Role of Palashakshara in the management of Garbhashayagrivagatavrana
(cervical erosion).”
Study purpose:
You are invited to participate in this research study because
Garbhashayagrivagatavrana (cervical erosion) is so common and causes so
many problems in day to day life. The purpose of this study is to prevent and
minimize the sign and symptoms of Garbhashayagrivagatavrana (cervical
erosion) by using the Palashakshara.
Study Procedure:
The study will be conducted on patients of outdoor of the Ayurvedic wing of Sir
Sunderlal Hospital, IMS, BHU in the Department of PrasutiTantra, diagnosed
with Garbhashayagrivagatavrana based on assessment criteria parameters.
Study benefits:
Using this drug (Palasha), which will be provided during research study might
help you to get rid of sign and symptoms of Garbhashayagrivagatavrana
(cervical erosion) and prevents the further complications and reccuranceof
disease.
Study risk:
Your participation in this study involves no additional risks, as these herbal
drugs have no side effects as described in our ayurvedic literature.
Confidentiality:
We will protect your confidentiality by having all research data collection forms
only identified by unique number and not by name or hospital code or address
or phone number. All research data will be kept in a secured room to which only
research staff members will haveaccess. The data of this research study may be
used for publication.  Any publication or presentation of the results of this
research will only give data on groups of patients so that not a single patient can
be identified individually by the member of the Institutional Review Board. The
board may have access to our records so that they can fulfil their role in
monitoring the safety and ethics of the study. 
Participation is voluntary:
Your participation in this study is completely voluntary. You can refuse to
participate or withdraw from the study at any time and this decision will never
affect your medical cases at S.S Hospital, BHU., now or in future. If you choose
to withdraw, the doctor may ask you to provide a reason for leaving the study.
After signing this form you cannot do any legal action against Human Rights. If
you do not come to one of the scheduled study visit, the doctor may try to
contact you directly or the people you indicated.
Question:
If you have any question, you are free to ask. We will try our best to answer
them. As a research subject, you can call the Institutional Review Board at
Banaras Hindu University. 

Signature of Patient Signature of Student

 B) Statement of consent

I have discussed this study with Dr. PragatiSaxena to my satisfaction. I have understood that
my participation is voluntary and that I can withdraw from the study at any time without
prejudice. I have read the above consent and I agree to enter this research study. I am
familiar with the fact that after signing this consent form, I cannot go for any legal action
against Human Rights.
I have been informed that if I believe that I have some problem as a result of participation in
this research study, I may contact the principal investigator, Dr. Anuradha Roy.
I can review the matter and identify the medical resources which may be available to me.

Participant’s Signature: Date:…/…/201..

Resident’s Medical Officer’s Signature: Date:…/…/201..
Supervisor’s Signature: Date:…/…/201..
Recruitment of participants for this study has been approved by the Banaras Hindu
University, Institutional Review Board.