| CTRI Number |
CTRI/2025/10/096606 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of healing effect of Putikadi Lepa and Jatyadi Taila in Dushta Vrana |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate Healing Effect Of Putikadi Lepa And Jatyadi Taila In Dushta Vrana |
| Trial Acronym |
Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Avnish Pathak |
| Designation |
Professor and HOD |
| Affiliation |
Faculty of Indian Medical System SGT University |
| Address |
Prof and HOD Dept of Shalya Tantra Faculty of Indian Medical System SGT University Gurugram Haryana India
Gurgaon
HARYANA
122505
India |
| Phone |
9886593705 |
| Fax |
|
| Email |
avnish_fims@sgtuniversity.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avnish Pathak |
| Designation |
Professor and HOD |
| Affiliation |
Faculty of Indian Medical System SGT University |
| Address |
Prof and HOD Dept of Shalya Tantra Faculty of Indian Medical System SGT University Gurugram Haryana India
Gurgaon
HARYANA
122505
India |
| Phone |
9886593705 |
| Fax |
|
| Email |
avnish_fims@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priti Yadav |
| Designation |
PhD Scholar |
| Affiliation |
FIMS, SGT University, Gurugram |
| Address |
Department of Shalya Tantra
FIMS SGT University Gurugram
HARYANA
122505
India |
| Phone |
9871217225 |
| Fax |
|
| Email |
dr.priti.yadav01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ishan Ayurvedic Medical College and Research Centre Greater Noida UP |
|
|
Primary Sponsor
|
| Name |
self |
| Address |
Ishan Ayurvedic Medical College and Research Centre Greater Noida UP |
| Type of Sponsor |
Research institution |
|
|
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 Priti Yadav |
Ishan Ayurvedic Hospital Greater Noida |
Room No 14
Dept of Shalya Tantra
Ishan Ayurvedic Medical College and Research Centre Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9871217225
dr.priti.yadav01@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:L979||Non-pressure chronic ulcer of unspecified part of lower leg. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jatyadi taila, Reference: Sharangadhar samhita, Route: Topical, Dosage Form: Taila, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: no | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Putikadi Lepa, Reference: Sushruta Samhita, Route: Topical, Dosage Form: Lepa Churna, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Lepa quantity will depend on the site |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having clinical features of Dushta Vrana and patients with controlled Diabetes Mellitus will be included |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Putikadi lepa will be effective in healing of dushta vrana |
the work is yet to be started |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/11/2025 |
| 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
|
This study is randomized, interventional and comparative type which consists of two parallel group to evaluate healing effect of Putikadi Lepa and Jatyadi Taila in Dushta Vrana. |