| CTRI Number |
CTRI/2026/02/103893 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of Karpoora Ghrita in Prasuta yoni Kshata(Episiotomy Wound) |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Study To Evaluate The Efficacy Of Karpoora Ghrita In The Management Of Prasuta Yoni Kshata(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 Phad Anushka Balasaheb |
| Designation |
PG Scholar |
| Affiliation |
SDMTs AMC Post Graduation Centre Terdal |
| Address |
SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATE CENTRE AND PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE
SIDDHANT NAGAR TERDAL
Bagalkot
KARNATAKA
587315
India |
| Phone |
9689993404 |
| Fax |
|
| Email |
anushka.phad123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parashuram K Rawal |
| Designation |
Professor and HOD Department of Striroga Evum Prasutitanta |
| Affiliation |
SDMTs AMC Post Graduation Centre Terdal |
| Address |
SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATE CENTRE AND PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE
SIDDHANT NAGAR TERDAL
Bagalkot
KARNATAKA
587315
India |
| Phone |
9880976151 |
| Fax |
|
| Email |
chaitanya.rawal5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Phad Anushka Balasaheb |
| Designation |
PG Scholar |
| Affiliation |
SDMTs AMC Post Graduation Centre Terdal |
| Address |
SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATE CENTRE AND PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE
SIDDHANT NAGAR TERDAL
Bagalkot
KARNATAKA
587315
India |
| Phone |
9689993404 |
| Fax |
|
| Email |
anushka.phad123@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Terdal bagalkot |
|
|
Primary Sponsor
|
| Name |
Dr Phad Anushka Balasaheb |
| Address |
SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Hospital Terdal |
| 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 Phad Anushka Balasaheb |
Padma Ayurvedic Hospital And Research Centre |
SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATE CENTRE AND PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE
SIDDHANT NAGAR TERDAL
Bagalkot
KARNATAKA |
09689993404
anushka.phad123@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:O718||Other specified obstetric trauma. Ayurveda Condition: SADYOVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Karpoora Ghrita, Reference: Chakradatta Samhita, Route: Topical, Dosage Form: Ghrita, Dose: 00(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Bahya Karma (Local Application) | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatadhouta Ghrita, Reference: Kaideva Nighantu, Route: Topical, Dosage Form: Ghrita, Dose: 00(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Bahya Karma (Local Application ) |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1 The subjects of age group within 21-35 years.
2 All primiparous women.
3 Singleton full term pregnancy who underwent normal vaginal delivery.
4 Subjects Underwent medio lateral episiotomy.
5 Subjects who are willing to sign on consent form. |
|
| ExclusionCriteria |
| Details |
1 Subjects with 3rd and 4th degree Perineal tear. subjects suffering from any complications like Cervical tear.
2 Subjects underwent LSCS .
3 Subjects with known Case of Diabetes Mellitus, Hypertension ,TB, STD’s,Anemia,Cancers,Bleeding disorders.
4 Immuno Suppressive therapy .
5 Subjects with known case of Hematoma or Abscess in vagina.
6 Assisted labor like forceps delivery, Instrumental delivery .
7 Complicated delivery(Abruptio placentae, Placenta Privia, Placenta accreta )
8 Postpartum hemorrhage .
9 Multipara with previous history of episiotomy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Trial Drug on Healing Of Prasuta Yoni Kshata( Epiosiotomy Wound) |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of trial drug and Adverse Drug Reaction on Episiotomy wound |
7 Days |
|
|
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)
|
11/03/2026 |
| 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="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
|
Episiotomy is a surgically planned incision made on the perineum and posterior vaginal wall during the second stage of labour to enlarge the vaginal opening and facilitate safe delivery of the foetus. Introduced in the early 1920s, it is one of the most common obstetric procedures performed to prevent severe perineal tears and ease delivery. However, it may lead to complications such as pain, infection, redness, swelling, fever, delayed wound healing, and occasionally perineal abscess, causing discomfort and delayed recovery in the mother. In Ayurveda, episiotomy wound can be correlated with Kshataja Vrana, a type of Sadhyo Vrana. Management includes Seevena Karma (suturing) followed by local application of Taila, Ghrita, and Lepa for proper wound healing, pain relief, and reduction of inflammation. Karpoor Ghrita, described in Shastra Kshata Chikitsa, possesses Vranashodhana (wound cleansing), Vranaropana (wound healing), Vedanashamaka (analgesic), and Shothahara (anti-inflammatory) properties. Similarly, Shatadhouta Ghrita is known for its wound healing and soothing effects. Therefore, this study is designed to evaluate the efficacy of Karpoor Ghrita in the management of Prasuta Yoni Kshata (episiotomy wound) to promote faster healing and reduce pain and complications. |