| CTRI Number |
CTRI/2025/08/093151 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
16/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Durvadi Taila and Povidone in Dustha Vrana |
|
Scientific Title of Study
|
A Comparative Clinical Study of Durvadi Taila and Povidone Iodine in Dustha 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 Kritika Sharma |
| Designation |
PG Scholar |
| Affiliation |
Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital |
| Address |
OPD No !! Dept of Shalya Tantra
Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital
Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital Bhaupur Farrukhabad
Farrukhabad
UTTAR PRADESH
209602
India |
| Phone |
8770523635 |
| Fax |
|
| Email |
sharmakritika.66666@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra G Verma |
| Designation |
Professor and HOD |
| Affiliation |
Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital |
| Address |
Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital Bhaupur Farrukhabad UP
Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital Bhaupur Farrukhabad UP
Farrukhabad
UTTAR PRADESH
209602
India |
| Phone |
9036563856 |
| Fax |
|
| Email |
ravivarma3856@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kritika Sharma |
| Designation |
PG scholar |
| Affiliation |
Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital |
| Address |
OPD NO 11 Dept of Shalya Tantra
Shri Babu Singh Jai Singh Ayurvedic Medical College and Hospital Bhaupur Farrukhabad UP
Shri Babu Singh Jai Singh Ayurvedic Medical College and Hospital Bhaupur Farrukhabad UP
Farrukhabad
UTTAR PRADESH
209602
India |
| Phone |
8770523635 |
| Fax |
|
| Email |
sharmakritika.66666@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD NO 11 Department of Shalya Tantra
Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital Bhaupur Farrukhabad UP 209602 |
|
|
Primary Sponsor
|
| Name |
Dr Kritika Sharma |
| Address |
OPD NO 11 Department of Shalya Tanta
Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital Bhaupur Farrukhabad UP 209602 |
| Type of Sponsor |
Other [Private Medical College] |
|
|
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 Kritika Sharma |
Dr Kritika Sharma |
OPD NO 11 Department of Shalya Tantra
Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital Bhaupur Farrukhabad UP 209602
Farrukhabad
UTTAR PRADESH |
08770523635
sharmakritika.66666@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | bandhanakarma ब नकम | (Procedure Reference: Shusruta Samhita, Procedure details: Clean the wound and bandage with ayurvedic formulation)
(1) Medicine Name: Durvadi Taila, Reference: Shusruta Samhita, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 1 Months(2) Medicine Name: Triphala Guggula, Reference: Baisajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 1 Months | | 2 | Comparator Arm | Procedure | - | bandhanakarma ब नकम | (Procedure Reference: Articals, Procedure details: Cleaning the wound and bandaging the wound )
(1) Medicine Name: Povidone Iodine, Reference: Articals, Route: Topical, Dosage Form: Dravaka, Dose: 5(ml), Frequency: od, Duration: 1 Months(2) Medicine Name: Triphala Guggula, Reference: Baisajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 1 Months |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from dushta vrana having clinical features like pricking and tearing type of pain foul smell pus discharge burning sensation itching were selected for the study
Patients with wound size of less than 10cm 5cm 1cm
Patients of either sex between the age group of 5 years and above
Patients suffering from systemic diseases like uncontrolled diabetes mellitus tuberculosis etc will be include in the present study |
|
| ExclusionCriteria |
| Details |
Patients suffering from grave condition like malignant ulcer and other severe illeness like HIV HbsAg will be exclude
Patients suffering from Dagdhavrana pressure ulcer Arterial ulcer
Patients having pre gangrenous or gangrenous changes
Patients suffering from osteomyelitis
Vrana present on allmovable and highly movable joints
Patients suffering from diabetic foot |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Complete wound healing |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain and Discharge reduction, Wound size reduction. |
1 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/09/2025 |
| 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="3"
Days="15" |
|
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
|
Acharya Sushruta mentions "Vrana Gatra Vichurnane", and "VranayatiitiVranaha". "Gatra" means tissue (body tissue or part of body) "Vichurnane’j means destruction, break, rupture, and discontinuity (of the Body or tissue)tili Vrana is the destruction or break, rupture, or discontinuity of body tissue or part of the body.  Wound is a break in the continuity of the covering epithelium in the skin or mucus membrane12J. It may either follow molecular death of the surface epithelium or its traumatic removal.
The Prevalence As per 2018 survey of wound in the world ranges from 1.9 to 13.1% of the total population. There are very few Indian studies on the epidemiology of chronic wounds.  The prevalence of chronic wounds was reported as 4.5 per 1000 population. For the category of chronic wounds resulting from various causes, such as diabetes, vascular diseases, pressure injuries, and others, the pooled prevalence rate for these wounds is reported as 2.21 per 1000 
The history of medical science starts with the art and skill of wound healing. Treatment of the wound was probably the first medical problem faced by human beings. The frequency of injuries was more common than any other disease. Even though healing of vrana is a natural process of the body, the vrana should be protected from dosha dusti, which delay the normal healing process. Dustavrana is common condition which we see in current surgical practice which is a buming problem to the sufferer from pain, cosmetic value and health care costs. This is a challenge to the surgeon and the health care system. This has dragged the attention of medical researchers, across the world Ayurvedic classics have given detailed explanations starting from nidana till management where definition of Shalya tantra also tells about the Dustavranavinischaya. |