| CTRI Number |
CTRI/2026/03/105709 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Panchvalkala Ointment and Povidone-lodine in the Treatment of Acute Wounds. |
|
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate The Antiseptic Effect Of Panchvalkal Ointment With Povidone iodine In The Managment Of Sadhyo
Vrana WSR To Acute Wound |
| 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 Aanchal Meena |
| Designation |
MS Scholar |
| Affiliation |
Post Graduate Institute Of Ayurved |
| Address |
PG Department of Shalya Tantra Post Graduate Institute of
Ayurved Jodhpur Dr Sarvepalli Radhakrishnan Rajasthan Ayurved
University Campus Karwar Jodhpur Rajasthan India
PG Department of Shalya Tantra Post Graduate Institute of
Ayurved Jodhpur, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved
University Campus Karwar Jodhpur Rajasthan India
Jodhpur
RAJASTHAN
301001
India |
| Phone |
6375136377 |
| Fax |
|
| Email |
anchalmeena784@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishnu dutt sharma |
| Designation |
MS ,PHD Shalya Tantra |
| Affiliation |
Post Graduate Institute Of Ayurved |
| Address |
PG Department of shalya tantra Post Graduate Institute of Ayurved
DSRRAU Jodhpur 342037 Jodhpur RAJASTHAN India
Department of Shalya Tantra Post Graduate Institute of Ayurved
DSRRAU Jodhpur
PG Department of shalya tantra Post Graduate Institute of Ayurved
DSRRAU Jodhpur 342037 Jodhpur RAJASTHAN India
Department of Shalya Tantra Post Graduate Institute of Ayurved
DSRRAU Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7742042974 |
| Fax |
|
| Email |
Ayurvishnu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishnu dutt sharma |
| Designation |
MS , PHD Shalya Tantra |
| Affiliation |
Post Graduate Institute Of Ayurved |
| Address |
PG Department of shalya tantra Post Graduate Institute of Ayurved
DSRRAU Jodhpur 342037 Jodhpur RAJASTHAN India
Department of Shalya Tantra Post Graduate Institute of Ayurved
DSRRAU Jodhpur
PG Department of shalya tantra Post Graduate Institute of Ayurved
DSRRAU Jodhpur 342037 Jodhpur RAJASTHAN India
Department of Shalya Tantra Post Graduate Institute of Ayurved
DSRRAU Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7742042974 |
| Fax |
|
| Email |
Ayurvishnu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved, Jodhpur |
| Address |
PG Department of Shalya Tantra Post Graduate Institute of
Ayurved DSRRAU Jodhpur 342037 Jodhpur RAJASTHAN India |
| Type of Sponsor |
Government 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 Aanchal Meena |
Post Graduate Institute Of Ayurved |
PG Department of
Shalya Tantr Post
Graduate Institute of
Ayurved DSRRAU
Jodhpur 342037
Jodhpur RAJASTHAN
India
Jodhpur, RAJASTHAN
Jodhpur
RAJASTHAN |
6375136377
anchalmeena784@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Institute of Ayurved Institutional Ethics Comitteee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Good |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: (Chakradutta 47/7), Procedure details: 1. Clean wound with normal saline.
2. Pat dry with sterile gauze.
3. Apply ointment as per wound surface.
4. Cover with sterile non-adherent dressing if required.
5. Record time & date of each application in CRF.)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age group 20- 65 years
Patient with Acute Wounds
Controlled DMT2and Hypertension |
|
| ExclusionCriteria |
| Details |
Patient suffering from any malignancy
Patient suffering from tuberculosis
Patient suffering from HIV& Hepatitis B
Patient suffering from any major uncontrolled systemic disorder viz HTN T2DM (more than 140 mg/dl) etc. will not be selected |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the antiseptic effect of Panchavalakala ointment with Povidone-iodine in the management of Sadhyo Vrana Acute Wound |
4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the rate of wound healing in both treatment group using standard parameters
Contemporary and comprehensive study of the related problem |
4 week |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
20/03/2026 |
| 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
|
This study is an interventional open label double arm randomized clinical study A total of 70 patients meeting the inclusion and exclusion criteria will be selected and randomly allocated simple randomization into two groups.
Group A Panchvalkal Ointment
Group B Betadine Povidone iodine Ointment
The study is open label meaning both the doctor and the patient are aware of the treatment being administered |