| CTRI Number |
CTRI/2020/08/027219 [Registered on: 18/08/2020] Trial Registered Prospectively |
| Last Modified On: |
17/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Nimbadi Gel and Nimbadi Taila in Dushta Vrana
|
|
Scientific Title of Study
|
A Comparative Clinical Evaluation of Nimbadi Gel and Nimbadi Taila w.s.r. to Dushta Vrana |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P Hemantha Kumar |
| Designation |
Professor and Head |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
PG Department of Shalya Tantra National Institute of Ayurveda Department of Shalya Tantra Jaipur Rajasthan
National Institute of Ayurveda campus Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414056362 |
| Fax |
|
| Email |
profphknia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Hemantha Kumar |
| Designation |
Professor and Head |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
PG Department of Shalya Tantra National Institute of Ayurveda Jaipur Rajasthan
National Institute of Ayurveda campus Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414056362 |
| Fax |
|
| Email |
profphknia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Hemantha Kumar |
| Designation |
Professor and Head |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
PG Department of Shalya Tantra National Institute of Ayurveda Jaipur Rajasthan
National Institute of Ayurveda campus Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414056362 |
| Fax |
|
| Email |
profphknia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalya Tantra National Institute of Ayurveda, Madhav vilas palace Amer Road Jaipur Rajasthan 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda Jaipur Rajasthan 302002 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Indrabir Mishra |
National Institute of Ayurveda Jaipur |
Shalya Department opd Room no 151 Jaipur Rajasthan
Jaipur
RAJASTHAN |
8770376486
imveer03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L984||Non-pressure chronic ulcer of skin, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nimbadi Gel |
No of patients: 15 Patient, will be treated with local application of Nimbadi Gel on Dushta Vrana,dose according to vrana size, two times per day, up to 4 weeks |
| Comparator Agent |
Nimbadi Taila |
No of patients: 15 Patient will be treated with local application of Nimbadi Taila on Dushta Vrana, dose according to vrana size, two times per day, up to 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 patients aged between 16-60 years
2 patients should fulfil the diagnostic criteria based on sign and symptoms of dushta vrana
|
|
| ExclusionCriteria |
| Details |
1 Patients more than 60 years and less than 16 years of age
2 Patient who has suffering from any wound which is related to systemic diseases like – Tubercular wound, Leprotic wound, Syphilitic wound etc.
3 Wound related to burn
4 Any malignant wound
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cured 90% relief in sign and symptoms and no recurrence during follow up
Marked improvement 76-90%
Moderate improvement 51-75%
Mild improvement 26- 50%
No improvement or less then 25%
|
after 4 week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Aggravation of symptoms |
after 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/08/2020 |
| 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="6"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Shalya Tantra is one of important branch of Ayurveda. Vrana is a very common clinical entity present with various signs and symptoms and create a great problem in surgical practice. Dushta Vrana is atypical non-healing ulcer which refuses to heal. In present study, local application of anubhoot yogas, Nimbadi Gel and Nimbadi Taila on Vrana for the management has been planned. Ingredients of Nimbadi Gel and Nimbadi Taila are same. In present study, 30 patients will be selected from OPD and IPD of PG Department of Shalya Tantra, National Institute of Ayurveda, Jaipur and patient randomly divided into 2 groups of 15 patients each, on the basis of inclusion and exclusion criteria. The patient will be treated with local application of Nimbadi Gel on Dushta Vrana in Group A and with Nimbadi Taila in Group B, up to 4 weeks, then compare the effect between Nimbadi Gel and Nimbadi Taila. |