| CTRI Number |
CTRI/2025/03/082449 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Wound healing] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the effect of Yastimadhu ghrita on episiotomy wound healing in women undergoing normal delivery. |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Effect of Yashtimadhu Ghrita on Episiotomy wound healing |
| 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 PREM CHAUDHARY |
| Designation |
P.G. Scholar |
| Affiliation |
Post Graduate Institute of Ayurveda Dr S R Rajasthan Ayurveda University Jodhpur Rajasthan |
| Address |
P.G. Department of Prasuti Tantra evum Stri Roga Post Graduate Institute of Ayurveda Dr S R Rajasthan Ayurveda University Jodhpur Rajasthan
P.G. Department of Prasuti Tantra evum Stri Roga Post Graduate Institute of Ayurveda Dr S R Rajasthan Ayurveda University Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
07742827531 |
| Fax |
|
| Email |
priyankabeniwal2109@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Neelima |
| Designation |
Professor & HOD |
| Affiliation |
Post Graduate Institute of Ayurveda Dr S R Rajasthan Ayurveda University Jodhpur Rajasthan |
| Address |
P.G. Department of Prasuti Tantra evum Stri Roga Post Graduate Institute of Ayurveda Dr S R Rajasthan Ayurveda University Jodhpur Rajasthan
P.G. Department of Prasuti Tantra evum Stri Roga Post Graduate Institute of Ayurveda Dr S R Rajasthan Ayurveda University Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9610350131 |
| Fax |
|
| Email |
aspneelima@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PREM CHAUDHARY |
| Designation |
P.G. Scholar |
| Affiliation |
Post Graduate Institute of Ayurveda Dr S R Rajasthan Ayurveda University Jodhpur Rajasthan |
| Address |
P.G. Department of Prasuti Tantra evum Stri Roga Post Graduate Institute of Ayurveda Dr S R Rajasthan Ayurveda University Jodhpur Rajasthan
P.G. Department of Prasuti Tantra evum Stri Roga Post Graduate Institute of Ayurveda Dr S R Rajasthan Ayurveda University Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
07742827531 |
| Fax |
|
| Email |
priyankabeniwal2109@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurveda Dr S R Rajasthan Ayurveda University Karwad Jodhpur Rajasthan 342037 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurveda Jodhpur Rajasthan |
| Address |
Pg Department of Prasuti Tantra evam Stri RogaPost Graduate Institute of Ayurveda Dr S R Rajasthan Ayurveda University Karwad Jodhpur Rajasthan 342037 |
| Type of Sponsor |
Research institution and 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 prem choudhary |
Post Graduate Institute of Ayurveda Dr S R Rajasthan Ayurveda University Karwad Jodhpur |
pg department of prasuti tantra evam stri roga pgia Dsrrau jodpur nagur road karwad 342037
Jodhpur
RAJASTHAN |
7742827531
priyankadeniwal2109@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee Post Graduate institute of Ayurveda, Jodhpur |
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: VRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: yastimadhu ghrita , Reference: vangsen varnashoth chikitsa 54/82, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 30(g), Frequency: qid, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 14 Days, Reference: No, Route: -, Dosage Form: Kalka/ Paste , Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Patient aged between 18-35 years.
Patients who underwent normal vaginal delivery with episiotomy. |
|
| ExclusionCriteria |
| Details |
Patient with severe anaemia[ less than 8g/dl
Patient with third degree perineal tear.
Patient with known case of allergic reaction.
Patients having positive VDRL,HIV, HBsAG. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce inflammation of Episiotomy wound and healing. |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in associated features like pain, sensation |
14 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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
|
Number of patients - 30
Type of study- Open
Drug- YASTIMADHU GHRITA
Dose- 30gm for 14 days
Route- Local Application
Duration of drug trial- 14 days
FOLLOW UP; The Follow up will be done:- 1st Follow up - 7th day from the beginning of the treatment 2nd Follow up -14th day from the beginning of the treatment |