| CTRI Number |
CTRI/2020/09/028130 [Registered on: 29/09/2020] Trial Registered Prospectively |
| Last Modified On: |
26/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Clinical Study To Evaluate Effect of WH5 Gel Vs Povidone Iodine Ointment in Dushta Vrana with special reference to Non-healing Wound |
|
Scientific Title of Study
|
Randomized Clinical Study To Evaluate The Effect of WH5 Gel Vs Povidone Iodine Ointment In The Management Of "Dushta Vrana" With Special Reference To Non-healing Wound |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
P Hemantha Kumar |
| Designation |
professor and head of department |
| Affiliation |
NATIONAL INSTITUTE OF AYURVEDA, JAIPUR, RAJASTHAN |
| Address |
P.G. Department of Shalya Tantra, National Institute of Ayurveda, Jaipur.
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414056362 |
| Fax |
|
| Email |
profphknia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Katarmal Durga Harishbhai |
| Designation |
Ph.D. scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
P.G.Department of Shalya Tantra, National Institute of Ayurveda, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9783725066 |
| Fax |
|
| Email |
bhanushalidurga256@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Katarmal Durga Harishbhai |
| Designation |
Ph.D.Scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
P.G.Department of Shalya Tantra, National Institute of Ayurveda, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9783725066 |
| Fax |
|
| Email |
bhanushalidurga256@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gufic Biosciences Limited |
|
|
Primary Sponsor
|
| Name |
Gufic Biosciences Limited |
| Address |
1 to 4 Floor, S.M. House, 11 Sahakar road,Vileparle (East ), Mumbai- 400 057, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| National Institute of Ayurveda |
National Institute of Ayurveda Jaipur,Rajasthan |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Katarmal Durga Harishbhai |
OPD and IPD of Shalya Tantra Department,National Institute of Ayurveda, Jaipur |
National Institute of Ayurveda,jaipur
Jaipur
RAJASTHAN |
9783725066
bhanushalidurga256@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, NIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M256||Stiffness of joint, not elsewhereclassified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Povidone iodine ointment |
Group B - Control group- Povidone iodine ointment -local application on wound followed by dressing with gauze and bandage daily once up to trial period |
| Intervention |
wh5 gel |
Group A- Trial group - WH5 GEL -local application on wound followed by dressing with gauze and bandage daily once up to trial period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having sign and symptoms of Dushta Vrana |
|
| ExclusionCriteria |
| Details |
1.Patients with severe complications and requiring surgery
2.Wound with other disorders like HIV ,Hepatitis B etc.
3.Malignant ulcer
4.Tuberculous ulcer
5.Syphilitic ulcer
6.Leprosy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of test drug and control drug effect on wound healing |
Active treatment-2months
Follow up-2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of patient compliance to test drug snd control drug |
Active treatment- 2 months
Follow up-2 months |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
05/10/2020 |
| 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="2"
Months="0"
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
|
Trial is on non healing wound .Purpose is to compare the trial drug - WH5 gel and control drug -povidone iodine ointment . It is randomised clinical trial with total sample size 60 patients - 30 patients in each group. |