| CTRI Number |
CTRI/2022/06/043080 [Registered on: 08/06/2022] Trial Registered Prospectively |
| Last Modified On: |
07/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of Vranashodhak Lepa For the Management Of Infected wound |
|
Scientific Title of Study
|
Randomized Open Controlled Clinical Study On The Role Of Vranashodhak Lepa In The Management Of Dushtavrana with special Reference To Infected Wound |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prtibha Uttareshwar Surawase |
| Designation |
PG Scholar |
| Affiliation |
Dr SUYOG PATIL |
| Address |
Yashwant Ayurved College,Kodoli,Tal.Panhala,Dist.Kolhapur
Yashwant Ayurved College,Kodoli,Tal.Panhala,Dist.Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
07028921994 |
| Fax |
|
| Email |
pratusurwase96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suyog Patil |
| Designation |
Associate Professor, Yashwant Ayurvedic College PGT and RC Kodoli |
| Affiliation |
Yashwant Ayurvedic College PGT and RC Kodoli |
| Address |
OPD no 4,Shalyatantra Department, Yashwant Ayurved College PGT and RC Kodoli,Tal.Panhala,Dist.Kolhapur
OPD no 4,Shalyatantra Department, Yashwant Ayurvedic College PGT and RC Kodoli, Tal Panhala, Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
07028921994 |
| Fax |
|
| Email |
drsuyog0222@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pratibha uttareshwar surawase |
| Designation |
PG Scholar |
| Affiliation |
Dr Suyog Patil |
| Address |
Yashwant Ayurved College Kodoli Dist Kolhapur
At post Kodoli Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7028921994 |
| Fax |
|
| Email |
pratusurwase96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Prtibha Surawase |
| Shalyatantra Department Yashwant Ayurved College and Hospital Kodoli Tal Panhala Dist Kolhapur 416114 |
|
|
Primary Sponsor
|
| Name |
Dr Prtibha Surawase |
| Address |
At post Kodoli Taluka Panhala Dist Kolhapur 416114 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Suyog Patil |
At post Kodoli Taluka Panhala Dist Kolhapur416114 |
| Prtibha Surawase |
At post Kodoli Taluka Panhala Dist kolhapur 416114 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prtibha Surwase |
Yashwant Ayurved College PGT and RC Kodoli |
Department of shalyatantra, 3rd floor
Kolhapur
MAHARASHTRA |
7028921994
pratusurwase96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Yashwant Ayurvedic College Kodoli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: DUSHTAVRANAH, (2) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, (3) ICD-10 Condition:L768||Other intraoperative and postprocedural complications of skin and subcutaneous tissue. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Povidone iodine ointment |
Local application of povidone iodine of thickness 0.5cm on alternate day for 20 days |
| Intervention |
Vranashodhak Lepa |
Local application of vranashodhak lepa of thickness 1cm on alternate day for 20 days |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Wounds with slough and foul smell
Size of wound-lenght and breathe 2to10cm
Depth upto 1cm
Controlled Diabetic Wounds |
|
| ExclusionCriteria |
| Details |
Wounds with excessive loss of tissues
Tuberculous ulcers
Venous ulcers
Malignant ulcers
Burns
Known case of HIV and HBsAg positive patients |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Slough
Smell
Pain
Swelling |
For 10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Size of wound
Granulation tissue |
For next 10 days |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
09/06/2022 |
| 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 Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pratusurwase96@gmail.com].
- For how long will this data be available start date provided 15-03-2021 and end date provided 25-12-2022?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The Thesis is Randomised Open Controlled Clinical Study on the Role of Vranashodhak Lepa in the Management Of Dushtavrana with special Reference to Infected Wound Control group drug is povidone iodine ointment |