| CTRI Number |
CTRI/2025/04/084879 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Nimbayavadi ointment on Non healing ulcer |
|
Scientific Title of Study
|
A clinical study to evaluate the Shodhana and Ropana effect of Nimbayavadi Ointment in the management of Dushta Vrana wsr to Non healing Ulcer |
| 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 Aditi Galav |
| Designation |
PG Scholar |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan |
| Address |
PG Scholar
PG Department of Shalya Tantra
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
8696254231 |
| Fax |
|
| Email |
aditigalav1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Hari Mohan Meena |
| Designation |
Professor and HOD |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan |
| Address |
Professor and HOD
PG Department of Shalya Tantra
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9782166260 |
| Fax |
|
| Email |
harimohanmeena961@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Hari Mohan Meena |
| Designation |
Professor and HOD |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan |
| Address |
Professor and HOD
PG Department of Shalya Tantra
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9782166260 |
| Fax |
|
| Email |
harimohanmeena961@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan India PIN 313001 |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan |
| Address |
Rada ji circle Ambamata Scheme Udaipur Rajasthan PIN 313001 |
| 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 Aditi Galav |
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan |
OPD No 1
PG Department of Shalya Tantra
Associated groups of Hospitals Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan PIN 313001
Udaipur
RAJASTHAN |
8696254231
aditigalav1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R238||Other skin changes. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nimbayavadi Ointment, Reference: Sushruta Samhita, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Povidone Iodine Ointment | Comparison with Group A |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients suffering from sign and symptoms of Dushta Vrana
2) Site of Ulcer - Any part of body
3) Ulcer area between 0.1 cm2 to 10 cm2
4) Duration of disease being less than 2 years |
|
| ExclusionCriteria |
| Details |
1) Patients suffering from uncontrolled diabetes mellitus and hypertension
2) Any malignancy and tuberculosis
3) Ulcer area more than 10 cm2 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Improvement of sign and symptoms of Dushtavrana
2) Reduction in length of ulcer
3) Relief from pain |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Improvement of sign and symptoms of Dushtavrana
2) Reduction in length of ulcer
3) Recurrence of Dushtavrana |
14 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
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)
|
This is an open labelled, parallel group clinical trial study. In this comparative study, Group A 30 patients will be administered with Nimbayavadi Ointment externally applied for duration of 1 month and parallel group B 30 patients will be administered with Povidone Iodine ointment externally applied for the duration of 1 month. |