| CTRI Number |
CTRI/2025/11/097815 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EFFECT OF SARJARASA MALAHAR IN EPISIOTOMY WOUND |
|
Scientific Title of Study
|
A CONTROLLED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF SARJARASA MALAHARA OVER KUMARI MAJJA WITH HARIDRA LEPA IN THE MANAGEMENT OF PRASUTA YONI KSHATA W.S.R TO EPISIOTOMY WOUND |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR NISHA ARUN BHARATI |
| Designation |
PG SCHOLAR |
| Affiliation |
SIDRAMAPPA DANIGOND MEMORIAL TRUSTS AYURVEDIC MEDICAL COLLEGE POST GRADUATION CENTRE |
| Address |
OPD DEPARTMENT OF PRASUTI TANTRA EVUM STREEROGA SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATION CENTRE PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE DR SIDDHANT NAGAR,TERDAL
OPD DEPARTMENT OF PRASUTI TANTRA EVUM STREEROGA SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATION CENTRE PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE DR SIDDHANT
Bagalkot
KARNATAKA
587315
India |
| Phone |
9768883545 |
| Fax |
|
| Email |
drnishabharati123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIDYAVATI PATHAK |
| Designation |
PROFESSOR |
| Affiliation |
SIDRAMAPPA DANIGOND MEMORIAL TRUSTS AYURVEDIC MEDICAL COLLEGE POST GRADUATION CENTRE |
| Address |
OPD DEPARTMENT OF PRASUTI TANTRA EVUM STREEROGA SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATION CENTRE PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE DR SIDDHANT NAGAR, TERDAL
OPD DEPARTMENT OF PRASUTI TANTRA EVUM STREEROGA SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATION CENTRE PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE DR SIDDHANT
Bagalkot
KARNATAKA
587315
India |
| Phone |
8310160682 |
| Fax |
|
| Email |
dr.vidyapattar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NISHA ARUN BHARATI |
| Designation |
PG SCHOLAR |
| Affiliation |
SIDRAMAPPA DANIGOND MEMORIAL TRUSTS AYURVEDIC MEDICAL COLLEGE POST GRADUATION CENTRE |
| Address |
OPD DEPARTMENT OF PRASUTI TANTRA EVUM STREEROGA SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATION CENTRE PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE DR SIDDHANT NAGAR,TERDAL
OPD DEPARTMENT OF PRASUTI TANTRA EVUM STREEROGA SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATION CENTRE PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE DR SIDDHANT
NAGAR,TERDAL
Bagalkot
KARNATAKA
587315
India |
| Phone |
9768883545 |
| Fax |
|
| Email |
drnishabharati123@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATION CENTRE PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE DR SIDDHANT NAGAR,TERDAL 587315 BAGALKOT KARNATAKA,INDIA |
|
|
Primary Sponsor
|
| Name |
DR NISHA ARUN BHARATI |
| Address |
SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATION CENTRE PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE DR SIDDHANT NAGAR,TERDAL 587315 BAGALKOT KARNATAKA |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR NISHA ARUN BHARATI |
SDMTs AYURVEDIC MEDICAL COLLEGE AND HOSPITAL TERDAL |
SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATION CENTRE PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE DR SIDDHANT NAGAR,TERDAL 587315
Bagalkot
KARNATAKA |
09768883545
drnishabharati123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDMTs AYURVEDIC MEDICAL COLLEGE AND PADMA AYURVEDIC HOSPITAL INSTITUTIONAL ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O700||First degree perineal laceration during delivery. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: KUMARI MAJJA WITH HARIDRA LEPA, Reference: Aacharya Priyavrat Sharma, Dravya guna vigyana Vol. 2, 5th chapter, Choukhamba Bharati Academy, Varanasi, 2 nd edition 1969, reprint 2011; page no 448,163., Route: Topical, Dosage Form: Kalka/ Paste , Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: NIL | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: SARJARASA MALAHARA, Reference: Dr Rao.G.Prabhakar text book of Bhaishajya Kalpana Vijnanam,Chaukambha Publications,New Delhi,1st Edition,11th chp Pg 326-327, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: NIL |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
•All Primi and Multi Gravida.
•Women who underwent normal Vaginal Delivery with Episiotomy.
•Subjects who are willing to sign on consent form.
|
|
| ExclusionCriteria |
| Details |
1.Subjects with 3rd and 4th degree Perineal tear. 2.Patient’s suffering from any complications like Cervical tear or post-partum Haemorrhage.
3.Subjects underwent LSCS.
4.Subjects with K/C/O Diabetes Mellitus, Hypertension etc.
5.Patient’s with K/C/O TB, STD’s etc.
6.Subjects suffering from any K/C/O Bleeding disorders.
7.Subjects with K/C/O Hematoma or Abscess in vagina.
8.Assisted labor like forceps delivery etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Trial Drug in management of Prasuta Yoni Kshata(Episiotomy wound). |
1day,7day,14day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Saftey of trial drug and Adverse Drug Reaction Aggravation in management of Prasuta Yoni Kshata(Episiotomy wound) |
1day,7day,14day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In Ayurveda there is brief mention of postpartum management i.e Sutika Chikitsa and complications. In Sutika Chikitsa there is mention of Yoni kshata which is a very common complication during childbirth. It comes under Kshataja Vrana that is sub type of Sadyo Vrana .It can be compared to Episiotomy that is indicated in 2nd stage of labour. Among 1,20,243 vaginal deliveries, episiotomy was performed in 63.4% cases. Genital tract injuries reported were 1stdegree perineal tear in 3.9%, 2nd degree perineal tear in 0.9%, 3rd and 4th degree perineal tear in 0.2%.Extension of episiotomy/ tear in 0.15%. Sarjarasa Malahara due to its Vrana Shodhan and Vrana Ropan Guna has been choosen for this study. It consists of Sarjarasa which has Madhura, Kashaya Rasa and Sheeta Guna .Tila Taila has Vrana Shodhan, Vrana Ropana Karma. Spatika due to its Kashaya Rasa has Sankochan Guna, it also has Guru, Snigdha Guna that promotes wound healing.
Sarjarasa Malahara and Kumari Majja with Haridra lepa both have wound healing properties, hence this study is designed to compare efficacy of both formulations in Prasuta Yoni Kshata. |