| CTRI Number |
CTRI/2026/02/103822 [Registered on: 13/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [external application over episiotomy wound] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to compare the wound healing effect of Yashtimadhu Ghrita pichu and Murivenna pichu over the stitch wound near vaginal opening made during normal delivery. |
|
Scientific Title of Study
|
A clinical study to compare the Episiotomy wound healing effect of Yashtimadhu Ghrita pichu and Murivenna pichu |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SONA C J |
| Designation |
PG SCHOLAR |
| Affiliation |
PNNM AYURVEDA MEDICAL COLLEGE AND HOSPITAL CHERUTHURUTHY |
| Address |
DEPARTMENT OF PRASUTITANTRA EVUM STREEROGA
PNNM AYURVEDA MEDICAL COLLEGE AND HOSPITAL
CHERUTHURUTHY
SHORNUR
THRISSUR
Thrissur
KERALA
679531
India |
| Phone |
9946674723 |
| Fax |
|
| Email |
sonacj24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SITHARA SATHEESAN |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
PNNM AYURVEDA MEDICAL COLLEGE AND HOSPITAL CHERUTHURUTHY |
| Address |
DEPARTMENT OF PRASUTITANTRA EVUM STREEROGA
PNNM AYURVEDA MEDICAL COLLEGE AND HOSPITAL
CHERUTHURUTHY
SHORNUR
THRISSUR
Thrissur
KERALA
679531
India |
| Phone |
9496115109 |
| Fax |
|
| Email |
sitharasatheesan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SONA C J |
| Designation |
PG SCHOLAR |
| Affiliation |
PNNM AYURVEDA MEDICAL COLLEGE AND HOSPITAL CHERUTHURUTHY |
| Address |
DEPARTMENT OF PRASUTITANTRA EVUM STREEROGA
PNNM AYURVEDA MEDICAL COLLEGE AND HOSPITAL
CHERUTHURUTHY
SHORNUR
THRISSUR
Thrissur
KERALA
679531
India |
| Phone |
9946674723 |
| Fax |
|
| Email |
sonacj24@gmail.com |
|
|
Source of Monetary or Material Support
|
| PNNM AYURVEDA MEDICAL COLLEGE AND HOSPITAL CHERUTHURUTHY
THRISSUR
KERALA
679531 |
|
|
Primary Sponsor
|
| Name |
SONA C J |
| Address |
PNNM AYURVEDA MEDICAL COLLEGE AND HOSPITAL CHERUTHURUTHY THRISSUR KERALA 679531 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SITHARA SATHEESAN |
PNNM AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF PRASUTITANTRA EVUM STREEROGA
PNNM AYURVEDA MEDICAL COLLEGE AND HOSPITAL
CHERUTHURUTHY
THRISSUR
KERALA
679531
Thrissur
KERALA |
9496115109
sitharasatheesan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE PNNM AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O759||Complication of labor and delivery, unspecified. Ayurveda Condition: SADYOVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | picu, पिचु | (Procedure Reference: Susrutha suthrasthana Utharasthana, Chapter 37,Sloga 27, Procedure details: Pichu made of sterile cotton and gauze to cover the episiotomy wound will be prepared and soaked in Murivenna and administered to subjects once daily)
(1) Medicine Name: Murivenna, Reference: Pharmacopeia by Govt Ayurveda College, Thiruvananthapuram, Route: Topical, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | picu, पिचु | (Procedure Reference: Susrutha suthrasthana Utharasthana, Chapter 37,Sloga 27, Procedure details: Pichu made of sterile cotton and gauze to cover the episiotomy wound will be prepared and soaked in Yashtimadhu ghrita and administered to subjects once daily )
(1) Medicine Name: Yashtimadhu ghrita, Reference: Susrutha suthrasthana, Chapter 5, sloga 42, Route: Topical, Dosage Form: Ghrita, Dose: 15(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Age group of 20 to 40 years
Both primi and multigravida who underwent vaginal delivery with episiotomy wound
Willingness to participate in the study |
|
| ExclusionCriteria |
| Details |
Women with Postpartum haemorrhage
Women who have puerperal sepsis
3rd degree and 4th degree perineal tear
Sexually transmitted diseases
Systemic diseases like Hypertension, blood coagulopathy
Gestational diabetes mellitus
Participants taking antibiotics during treatment |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Episiotomy wound healing(REEDA scale-Redness,Edema,Ecchymosis,Discharge and Approximation)
Pain reduction(VAS-Visual Analogue Scale)
|
Both assessment will be done on 5th day of vaginal delivery(pre assessment-before procedure), 8th day(intermediate assessment-before procedure), 12th day(post assessment) of vaginal delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
24/02/2026 |
| 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="6"
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
|
This is a comparative interventional clinical study to evaluate the episiotomy wound healing effect of Yashtimadhu ghrita pichu and Murivenna pichu. 38 women with episiotomy wound following vaginal delivery will be selected and divided in to 2 groups by simple random sampling using lottery method. Group A will receive Yashtimadhu ghrita pichu and group B will receive Murivenna pichu. Pain will be assessed using VAS scale and wound healing using REEDA scale. Observations will be recorded at 5th, 8th and 12th day vaginal delivery. The study duration is 18 months |