| CTRI Number |
CTRI/2020/11/028890 [Registered on: 04/11/2020] Trial Registered Prospectively |
| Last Modified On: |
29/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Non-healing ulcer and its management through Ayurveda |
|
Scientific Title of Study
|
A clinical study on Jalaukavcharana followed with Karanjadi Ghrit dressing for the management of dusta varna w.s.r. to Non-Healing Ulcer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dashrath Singh Bhati |
| Designation |
PG Scholar |
| Affiliation |
DSRRAU, Jodhpur |
| Address |
PG Department Of Shalya Tantra DSRRAU Campus,Nagaur road, Karwar,Jodhpur
Rajasthan
PG Department Of Shalya Tantra DSRRAU Campus,Nagaur road, Karwar,Jodhpur
Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7734952322 |
| Fax |
|
| Email |
dashrathbhati1989@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishnu Dutt Sharma |
| Designation |
Assistant Professor |
| Affiliation |
DSRRAU, Jodhpur |
| Address |
PG Department Of Shalya Tantra DSRRAU Campus,Nagaur road, Karwar,Jodhpur
Rajasthan
PG Department Of Shalya Tantra DSRRAU Campus,Nagaur road, Karwar,Jodhpur
Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7742042974 |
| Fax |
|
| Email |
ayurvishnu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dashrath Singh Bhati |
| Designation |
PG scholar |
| Affiliation |
DSRRAU, Jodhpur |
| Address |
PG Department Of Shalya Tantra DSRRAU Campus,Nagaur road, Karwar,Jodhpur
Rajasthan
PG Department Of Shalya Tantra DSRRAU Campus,Nagaur road, Karwar,Jodhpur
Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7734952322 |
| Fax |
|
| Email |
dashrathbhati1989@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur |
|
|
Primary Sponsor
|
| Name |
Dr Sarvepalli Radhakrisanan Rajasthan Ayurved University Jodhpur |
| Address |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Nagaur road, Karwar, Jodhpur, Rajasthan 342037
|
| 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 Vishnu Dutt Sharma |
Dr. Sarvepaali Radhakrishanan Rajasthan Ayurved University, University Hospital of Ayurveda |
OPD
No.-7,P.G.Department
of Shalya Tantra,
DSRRAU Karwar,
Nagaur road, Jodhpur Rajasthan
Jodhpur
RAJASTHAN |
7742042974
ayurvishnu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee DSRRAU Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Jalaukavcharana followed with Karanjadi Ghrit |
After examination and preparation of the patient, the dushta vrana is cleaned
with normal saline after that the jaulaka will applied on the dushta vrana as per
the guidelines of shushrut mentioned in Shu. Sutra. Adhyay 13. The jauloka will be
applied with the same procedure after seven days.
On next day after cleaning the site of dushta vrana with normal saline, local
application of karanjadi ghrit will be applied on wound plane in thin layer , then it
will be covered by sterile gauze piece and put a cotton pad with suitable bandage.
This process will be repeated for next six days before applying the jauloka on
seventh day.jauloka will be repeated for 4 times on every 7th day.The total duration of trial is one month. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient who will give written consent
2.Patient suffering from dushta vrana or patient having clinical features
of dushta vrana .
3.Any post operative non healing ulcer which are irrespective to any
specific as well as non specific procedure. |
|
| ExclusionCriteria |
| Details |
1.Patient suffering from any malignancy.
2.Patient suffering from HIV, & Hepatitis B.
3.Patient suffering from any major systemic disorder.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in subjective and objective parameters |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the efficacy of treatment |
1 month |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
11/11/2020 |
| 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="0"
Months="6"
Days="0" |
|
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
|
This study is a single group randomized trial. Present study is planned to evaluate the efficacy of Jalaukavcharna and Karanjadi Ghrit in the management of Dushta Vrana or non-healing ulcer. In single group 60 clinically diagnosed and registered patients of Dushta Vrana or non-healing ulcer will be taken. The Dushta Vrana will be cleaned with normal saline after that Jalauka will be applied on Dushta Vrana .the Jalauka will be applied after 7 days with the same procedure. one next day after cleaning the site of Dushta Vrana with normal saline , local application of Karanjadi Ghrit will be applied on wound plane in thin layer, then it will be covered by sterile gauze piece and put a cotton pad with suitable bandage. this process will be repeated for next 6 days before applying the Jalauka on 7th day. Jalauka will be repeated on every 7th day for 4 times. total duration of trial is 1 month. |