| CTRI Number |
CTRI/2025/11/097624 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
15/11/2025 |
| 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 VRANAMRITA SHWETA MALAHARA IN DUSTA VRANA |
|
Scientific Title of Study
|
A RANDOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF VRANAMRITA SHWETA MALAHARA AND GANDHAKADYA MALAHARA IN MANAGEMENT OF DUSTA VRANA. |
| 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 VISHWAJIT NITIN PATIL |
| Designation |
PG Scholar |
| Affiliation |
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduate Centre |
| Address |
SDM Trusts Ayurvedic Medical College Danigond Post Graduate Centre And Padma Ayurvedic Hospital And Research Centre Terdal Shalya Dept
SDM Trusts Ayurvedic Medical College Danigond Post Graduate Centre And Padma
Ayurvedic Hospital And Research Centre Terdal Shalya Dept
Bagalkot
KARNATAKA
587315
India |
| Phone |
7758886080 |
| Fax |
|
| Email |
vishwajitpatil33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUJATA B WADDAR |
| Designation |
Professor |
| Affiliation |
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduate Centre |
| Address |
SDM Trusts Ayurvedic Medical College Danigond Post Graduate Centre And Padma
Ayurvedic Hospital And Research Centre Terdal Shalya Dept
SDM Trusts Ayurvedic Medical College Danigond Post Graduate Centre And Padma
Ayurvedic Hospital And Research Centre Terdal Shalya Dept
Bagalkot
KARNATAKA
587315
India |
| Phone |
8105401470 |
| Fax |
|
| Email |
sujata.bw@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VISHWAJIT NITIN PATIL |
| Designation |
PG Scholar |
| Affiliation |
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduate Centre |
| Address |
SDM Trusts Ayurvedic Medical College Danigond Post Graduate Centre And Padma
Ayurvedic Hospital And Research Centre Terdal Shalya Dept
SDM Trusts Ayurvedic Medical College Danigond Post Graduate Centre And Padma
Ayurvedic Hospital And Research Centre Terdal Shalya Dept
Bagalkot
KARNATAKA
587315
India |
| Phone |
7758886080 |
| Fax |
|
| Email |
vishwajitpatil33@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDMTs Ayurvedic Medical College and Padma Ayurvedic Hospital Institutional Ethics Committee
for Research on Human Subjects Shalya Dept 2nd Floor Room No 1 Terdal 587315 Karnataka
India |
|
|
Primary Sponsor
|
| Name |
DR VISHWAJIT NITIN PATIL |
| Address |
SDM Trusts Ayurvedic Medical College Danigond Post Graduate Centre And Padma
Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal 587315
Karnataka India |
| 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 VISHWAJIT NITIN PATIL |
Padma Ayurvedic Hospital And Research Centre |
SDM Trusts Ayurvedic Medical College Danigond Post Graduate Centre And Padma
Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal Shalya Dept
SDM Trusts Ayurvedic Medical College Danigond Post Graduate Centre And Padma
Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal Shalya Dept
Bagalkot
KARNATAKA |
07758886080
vishwajitpatil33@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM TRUST AYURVEDIC MEDICAL COLLEGE AND PADMA AYURVEDIC HOSPITAL INSTITUTIONAL ETHICS COMMITEE FOR RESEARCH ON HUMAN SUBJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T148||Other injury of unspecified body region. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vranamrita shweta malahara, Reference: -rasatantrasara and sidhprayog sangraha part a, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 31 Days, anupAna/sahapAna: No, Additional Information: no | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: GANDHAKADYA MALAHARA, Reference: rasatarangini , Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 31 Days, anupAna/sahapAna: No, Additional Information: -no |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having classical signs and symptoms of Dushtavrana.
Age group of 18 to 60 years.
Wound of Grade 0 1 2 of Wagners classification
Size of the wound up to 8x8cm.
Patients with controlled diabetes RBS BELOW 150 mg/dl will be included for the study. |
|
| ExclusionCriteria |
| Details |
Wound of 3 4 5 grade as per Wagners classification.
Patients with K/C/O HIV HBSAG TB Uncontrolled Diabetes will be Excluded.
Leprotic ulcer Tuberculosis Malignant wounds. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effect of vranamrita shweta malahara and gandhakadya malahara in dushta vrana. |
effect of vranamrita shweta malahara and gandhakadya malahara in dushta vrana. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to see the effect of vranamrita shweta malahara in dushta vrana |
0 11 21 31st day |
|
|
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)
|
28/11/2025 |
| 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 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
|
There are few Indian studies on the epidemiology of chronic wounds, one study
estimated the prevalence at 4.5/1000population. According to an Indian Community-based
Epidemiological Study of Wounds, the percentage was 4.5% in India [1].
Shalya Tantra an ancient Indian surgery deals with different kinds of Vrana and its
Management, which refers for, “Vrana Gatra Vichoornane" discontinuity of skin/other body
tissues. Wound is break in continuity of the skin/tissue, wound infection continue to represent
major medical problem in term of outcome of surgical procedure [2]. In Ayurveda infected wound
can be correlated to Dushta vrana. Chronic wound e.g. Diabetic foot ulcer, presser ulcer, venous
ulcer may be considered infectious, classical signs include Pain, delayed healing, discharge, Peri
wound edema, malodors, wound discoloration, induration, purulent exudate. Proper wound care
is necessary to prevent infection & promote healing of wound [3].
Sushruta has elaborately explained Dushta Vrana with its Lakshana and management.
A wound which refuses to heal/heals very slowly is known as Dushta Vrana. Dushta vrana can
be nearly correlated with that of infected wound [4].
Acharya Sushruta elaborately described about the treatment of Vrana in Shasti
Upakrama [5]. Lepa is one among them used in the treatment due to its direct application on the
Vrana for better absorption.
Malahara are preparation frequently used in the management of Dushta vrana, has Vrana
Ropana and Shodhana, Snehana, Lekhana action [6]. Hence in this study here an attempt is made
to explore the effect of Vranamrita Shweta Malahara [12] in the management of Dustha Vrana and
to compare its effect with Gandhakadya Malahara [13,20,21] due to its Lekhana and Twak Doshahara
properties. |