| CTRI Number |
CTRI/2025/05/087940 [Registered on: 30/05/2025] Trial Registered Prospectively |
| Last Modified On: |
29/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study To Test The Healing Effect Of Darvyadighrita When Applied To Episiotomy Wounds After Childbirth |
|
Scientific Title of Study
|
An Open Randomized Controlled Clinical Study To Evaluate The Vranaropak Effect Of Darvyadighrita Local Application On Vitapchedan With Special Reference 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 |
Anjali Bhaskarrao Savade |
| Designation |
PG scholar |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion Mumbai |
| Address |
Floor No.3 Department of Prasutitantra and Stree rog APMs Ayurved Mahavidyalaya near sion railway station Sion East Mumbai 400022
Floor No.3 Department of Prasutitantra and Stree rog APMs Ayurved Mahavidyalaya near sion railway station Sion East Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9970167582 |
| Fax |
|
| Email |
anjalisavade88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anjali Bhaskarrao Savade |
| Designation |
PG scholar |
| Affiliation |
APMS Ayurved Mahavidyalaya Sion |
| Address |
Floor No.3 Department of Prasutitantra and Stree rog APMs Ayurved Mahavidyalaya near sion railway station Sion East Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9970167582 |
| Fax |
|
| Email |
anjalisavade88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujata Shrikant Jagtap |
| Designation |
HOD And Professor |
| Affiliation |
APMS Ayurved Mahavidyalaya Sion |
| Address |
Department of Prasutitantra even Streeroga 3rd floor APMs
Ayurved Mahavidyalaya near
Sion railway station sion East
Mumbai
APMs Ayurved Mahavidyalaya near sion railway station Sion Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9820556568 |
| Fax |
|
| Email |
sujatashrikantjagtap@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Seth RV Ayurved Hospital |
| Address |
APMs Ayurved Mahavidyalaya Near sion railway station sion Mumbai |
| Type of Sponsor |
Other [Charitable Ayurvedic Hospital ] |
|
|
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 Anjali Bhaskarrao Savade |
Seth R.V. Ayurvedic Hospital |
APMs Ayurved Mahavidyalaya near sion railway station Sion East Mumbai
Mumbai
MAHARASHTRA |
9970167582
anjalisavade88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sion Ayurved College IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O860||Infection of obstetric surgical wound. Ayurveda Condition: VITAPA-MARMAVIDDHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Darvyadighrita, Reference: Gadnigraha adhyay no39 shloka 60 61, Route: Topical, Dosage Form: Ghrita, Dose: 3(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Povidine iodine 5% Solution, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 3(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Primiparous women with normal vaginal delivery with episiotomy
Multiparous women with normal vaginal delivery with episiotomy
1st and 2nd degree perineal tear
Age group 19 to 40years
Patient irrespective of Religion
Cast
Socio economic status
Occupation
Laboratory investigations for inclusion criteria
CBC
BSLR
HIV
HBSAG
VDRL
Urine routine
Patients with informed written consent prior to delivery |
|
| ExclusionCriteria |
| Details |
Women with Systemic disorders like Diabetes Mellitus Hypertension Pulmonary
tuberculosis
Patients having perineal hematoma or abscess
Patients with serology positive for HIV VDRL HBsAg HCV
Normal delivery with intrapartum complications like PPH Manual removal of placenta 3rd
and 4th degree perineal tear
Severe Anaemic patients less than 7gm per dl Hb |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vranaropan |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Vranavedana (Pain)
Vranagandha (Foul smell)
Vranashotha (Inflammation)
Vranastrava (Discharge) |
7 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
11/06/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Pregnancy and childbirth are critical phases that greatly influence a womans physical and mental health especially during the postpartum period known in Ayurveda as Sutikakaal. This period demands specialized care to aid recovery after the physical strain of vaginal delivery. In modern obstetrics an episiotomy a surgical incision made during labor facilitates childbirth but often results in wounds that can cause pain swelling and discomfort impacting daily activities. While classical Ayurvedic texts do not directly mention episiotomy they extensively describe wound types Vrana and their treatments. Darvyadighrita a traditional Ayurvedic formulation possesses properties such as wound healing Vranaropak pain relief Vedanasthapak anti-inflammatory Shothagna and antimicrobial effects. This study explores its effectiveness in promoting faster healing of episiotomy wounds aiming to reduce postpartum discomfort and improve early maternal well-being. |