| CTRI Number |
CTRI/2025/02/080323 [Registered on: 11/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Patolyadi Lepa in Infected wound (Dushta Vrana).
|
|
Scientific Title of Study
|
Randomized Controlled Clinical trial to study the effect of Patolyadi Lepa in the management of Dushta Vrana w. s. r. to infected 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 Vaishnavi Shivprasad Golwa |
| Designation |
M. S. Scholar Shalyatantra samanya department |
| Affiliation |
Shree Saptashrungi Ayurvedic Mahavidyalaya |
| Address |
Department of Shalyatantra Samanya, Shree Saptashrungi Ayurved
Mahavidyalaya,Kamal nagar Hirawadi, Panchavati, Nashik,
Maharashtra 422003 India
Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
7028867684 |
| Fax |
|
| Email |
dr.vaishnavigolwa99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Ahire |
| Designation |
Professor |
| Affiliation |
Shree Saptashrungi Ayurvedic Mahavidyalaya |
| Address |
Department of Shalyatantra Samanya,Shree Saptashrungi Ayurved
Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik,
Maharashtra 422003 India
Nashik
MAHARASHTRA
422003
India |
| Phone |
9623843106 |
| Fax |
|
| Email |
ramesh.v.ahire@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh Ahire |
| Designation |
Professor |
| Affiliation |
Shree Saptashrungi Ayurvedic Mahavidyalaya |
| Address |
Department of Shalyatantra Samanya,Shree Saptashrungi Ayurved
Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik,
Maharashtra 422003 India
Nashik
MAHARASHTRA
422003
India |
| Phone |
9623843106 |
| Fax |
|
| Email |
ramesh.v.ahire@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shalyatanta department,OPD no. 1,Shree Saptashrungi Ayurved Mahavidyalaya And Hospital ,
KamalNagar , Hirawadi , Panchvati, Nashik Maharashtra 422003 |
|
|
Primary Sponsor
|
| Name |
Department of Shalyatantra Shree Saptashrungi Ayurved Mahavidyalaya |
| Address |
Department of Shalyatantra Samanya,OPD no. 1,Shree Saptashrungi Ayurved
Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik,422003
Maharashtra India |
| Type of Sponsor |
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 Vaishnavi Shivprasad Golwa |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital |
Department Of
Shalyatanta,OPD no.
1,Kamal
Nagar , Hirawadi ,
Panchavati , Nashik 422003
Nashik
MAHARASHTRA |
7028867684
dr.vaishnavigolwa99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree Saptashrungi Ayurved Mahavidyalaya Nashik Panchavati Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Patolyadi Lepa, Reference: Bhaishajyaratnawali, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 05(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 05 Days, anupAna/sahapAna: No, Additional Information: No additional information. | | 2 | Comparator Arm (Non Ayurveda) | | - | Betadine Ointment | Local application of Betadine ointment at the site of infected wound with the help of gauze piece and dressing done 2 times per day for the 5 days. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients having lakshanas of Dushta Vrana.
2) Patients aged between 18 to,70 years, irrespective of gender, socioeconomic status. 3) Wounds which are present to extremities only.
4) Dimension of wound up to 36 sq.cm. |
|
| ExclusionCriteria |
| Details |
1)Patient positive with HIV, HBsAG.
2)Patient suffering from Osteomyelitis, Malignancy.
3)Patient below age group under 18 and above 70.
4)Patients with other skin lesions around the area of wound.
5)Patients suffering from any serious systemic diseases.
6)Wound size more than 36 sq.cm. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce the sign and symptoms of Infected wound (Dushta Vrana). |
5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce recurrence & further infection. |
10 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
18/02/2025 |
| Date of Study Completion (India) |
12/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Cost friendly. Easily available. Patient make at their home also. Easy to apply on wound.
|