| CTRI Number |
CTRI/2025/08/093622 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Durvadi tail effect in Wound healing |
|
Scientific Title of Study
|
Comprehensive Single Arm Trial in The Management of Dustha Vrana (Wound) WSR to Culture and Sensitivity Test |
| 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 PRINCE MEENA |
| Designation |
MS SCHOLAR |
| Affiliation |
POSTGRADUATE INSTITUTE OF AYURVEDA |
| Address |
P.G.Department of Shalyatantra Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur
Jodhpur
Jodhpur RAJASTHAN 342037 India |
| Phone |
9680888691 |
| Fax |
|
| Email |
princeasari@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR SANJAY SRIVASTAVA |
| Designation |
ASSOICATE PROFESSOR |
| Affiliation |
POSTGRADUATE INSTITUTE OF AYURVEDA |
| Address |
P.G.Department of Shalyatantra Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur
Jodhpur
Jodhpur RAJASTHAN 342037 India |
| Phone |
9414410383 |
| Fax |
|
| Email |
sanjayphyayu@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR PRINCE MEENA |
| Designation |
MS SCHOLAR |
| Affiliation |
POSTGRADUATE INSTITUTE OF AYURVEDA |
| Address |
P.G.Department of Shalyatantra Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur
Jodhpur
Jodhpur RAJASTHAN 342037 India |
| Phone |
9680888691 |
| Fax |
|
| Email |
princeasari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur – 342037 (Rajasthan)
|
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved |
| Address |
Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur – 342037 (Rajasthan)
|
| 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 PRINCE MEENA |
Sanjivani hospital Post Graduate Institute of Ayurved |
OPD Room No.14, Department of Shalyatantra, Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
Jodhpur
RAJASTHAN Jodhpur RAJASTHAN |
9680888691
princeasari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Post Graduate Institute of Ayurved, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur |
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: Durvadi Tail, Reference: Chakrdatta, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 30 Days, Reference: No, Route: -, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with classical sign and symptom of DushtaVrana for example diabetic wound will be
included in the trial
Patient who will give written consent |
|
| ExclusionCriteria |
| Details |
Patient suffering from any malignancy.
Patient who is not eligible for Shodhan of Vrana according to Sushrut Samhita.
Patient suffering from tuberculosis.
Patient suffering from HIV & Hepatitis B.
Patient suffering from any major systemic disorder. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Generation of scientific evidence on the efficacy of Durvadi Taila in wound management in context of
antimicrobial properties. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcomes will provide a more comprehensive and indepth understanding of the potential
benefits, safety, and broader implications in clinical practice of Durvadi Taila and contributing to
evidence-based decision-making for wound management |
30 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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/09/2025 |
| 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="0" Months="6" 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
|
Comprehensive Single-Arm Trial to Investigate the Efficacy of Durvadi tail in the Management of DushtaVrana (Wound)WSR to Culture & Sensitivity Test in this study primary aim to rule out How effective is Durvadi Tail in promoting wound healing and preparing the wound bed for optimal healing conditions |