| CTRI Number |
CTRI/2025/09/094757 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
13/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Evaluate The Efficacy Of Ropana Effect Of Priyangvadi Churna On Shuddha Vrana. |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Trial To Evaluate The Ropana Effect By Avachurnan Of Priyangvadi Churna On Shuddha 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 Gaikwad Ruturaj Mohanrao |
| Designation |
PhD Scholar |
| Affiliation |
Yeshwant Ayurvedic College |
| Address |
Yeshwant Ayurvedic College Ap kodoli Tal panhala Dist kolhapur
Kolhapur MAHARASHTRA 416114 India |
| Phone |
9960760638 |
| Fax |
|
| Email |
ruturajmgaikwad@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr LAXMI MAROTI NARHARE |
| Designation |
Professor of Shalyatantra Department |
| Affiliation |
Yeshwant Ayurvedic College |
| Address |
Yeshwant Ayurvedic College, Ap Kodoli,Tal-Panhala, Kolhapur
Kolhapur MAHARASHTRA 416114 India |
| Phone |
9822189226 |
| Fax |
|
| Email |
drlaxminarhare@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr LAXMI MAROTI NARHARE |
| Designation |
Professor of Shalyatantra Department |
| Affiliation |
Yeshwant Ayurvedic College |
| Address |
Yeshwant Ayurvedic College, Ap Kodoli,Tal-Panhala, Kolhapur
Kolhapur MAHARASHTRA 416114 India |
| Phone |
9822189226 |
| Fax |
|
| Email |
drlaxminarhare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yeshwant Ayurved Medical college Shalyatantra Department, Kodoli, District. Kolhapur |
|
|
Primary Sponsor
|
| Name |
Dr Ruturaj Mohanrao Gaikwad |
| Address |
Yeshwant Ayurvedic College, Ap. Kodoli,Tal-Panhala, Kolhapur |
| 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 Ruturaj Mohanrao Gaikwad |
Yeshwant Ayurvedic Dharmarth Rugnalaya |
Yeshwant Ayurvedic dharmarth Rugnalaya shalyatantra male and female ward no 1 ,2 and shalyatantra opd ,Ap. Kodoli,Tal-Panhala, Kolhapur. Kolhapur MAHARASHTRA |
9960760638
ruturajmgaikwad@gmail.com |
|
|
Details of Ethics Committee
|
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L989||Disorder of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: SUDDHAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | avacUrNanam, अवचूर्णनम् | (Procedure Reference: Bhavprakash vrana ropana chikitsa adhyay, Procedure details: 1.Vrana Prakshalan(cleaning of wound) will be done with normal saline.
2.Then sufficient amount of Priyangvadi Churna will dust over the
wound
3..After that a sterile dressing pad having sufficient length will be placed
over the wound.
4.Proper dressing will be done with sterile bandage cloth.
5.This will be repeated daily for 15 days) (1) Medicine Name: Priyangvadi churna, Reference: Bhavprakash, Route: Topical, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: od, Duration: 15 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Nanocrytalline silver gel | |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients irrespective of gender, economic class, caste, religion
Patient having sign and symptoms of Shuddha Vrana having area less then length 5x 5 cm & max
depth 5 mm will be randomly selected |
|
| ExclusionCriteria |
| Details |
Known cases of HIV, Hepatitis B, any systemic disease
Dushta Vrana(Infected wounds)
Diabetic ulcers
Tubercular Ulcers
Venous Ulcers
Leprotic Ulcers
Malignant Ulcers
Burns
Wounds having excessive loss of Tissues i.e.wound include bone,and tendon injury, exposed bone |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief from symptoms and wound healing |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome will be to determine whether the interventional
drug is better than the controller drug |
15 days |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
18/10/2025 |
| 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="3" 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
|
The thesis titled “A Randomized Controlled Clinical Study to Evaluate the Ropana Effect of Priyangvadi Churna Avachurnan on Shuddha Vrana” explores the role of a traditional Ayurvedic formulation in wound healing. In Ayurveda, Vrana (wound) is considered a critical condition that requires careful management, with Ropana (healing) being one of the sixty wound-care measures described by Acharya Sushruta. While modern medicine often employs antimicrobial dressings such as silver-based preparations, Ayurvedic classics highlight natural formulations like Priyangvadi Churna for their healing and restorative properties.
This study has been designed as a randomized controlled clinical trial with a total of 120 patients diagnosed with Shuddha Vrana (clean, non-infected wounds). The participants will be divided into two equal groups: the trial group will receive Priyangvadi Churna dressing through the Avachurnan method, while the control group will be treated with nanocrystalline silver gel, a widely accepted modern wound-healing agent. Both groups will undergo daily dressing for 15 days.
Assessment parameters include wound size reduction, discharge, color changes, tenderness, and granulation tissue development. Observations will be documented every three days. The collected data will be statistically analyzed to determine the comparative effectiveness of Priyangvadi Churna.
The study aims not only to validate the traditional claims of Ayurvedic texts but also to establish scientific evidence for using Priyangvadi Churna as a cost-effective, natural, and safe alternative in wound management. If successful, this research could strengthen integrative approaches in surgery and wound care, bridging classical Ayurvedic wisdom with modern clinical practice.
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