| CTRI Number |
CTRI/2023/07/054977 [Registered on: 10/07/2023] Trial Registered Prospectively |
| Last Modified On: |
07/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of panchwalkal kwath and katphaladi avachurna on diabetic ulcer |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of Panchwalkal kwath and Katphaladi avachurna in the management of dusta vrana W.S.R to Diabetic 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 Mukesh Kumar Sharma |
| Designation |
PG Scholar |
| Affiliation |
Madan Mohan Malaviya Government Ayurved college Udaipur |
| Address |
PG Scholar
Shalya tantra Department
Madan Mohan Malaviya Government Ayurved College Udaipur
PIN 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
8769491286 |
| Fax |
|
| Email |
dr.m.k.sharma9191@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hari Mohan Meena |
| Designation |
Professor |
| Affiliation |
Madan Mohan Malaviya Government Ayurved college Udaipur |
| Address |
Professor
Shalya tantra Department
Madan Mohan Malaviya Government Ayurved College Udaipur
PIN 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
9782166260 |
| Fax |
|
| Email |
dr_harimohan@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hari Mohan Meena |
| Designation |
Professor |
| Affiliation |
Madan Mohan Malaviya Government Ayurved college Udaipur |
| Address |
Professor
Shalya tantra Department
Madan Mohan Malaviya Government Ayurved College Udaipur
PIN 313001
RAJASTHAN
313001
India |
| Phone |
9782166260 |
| Fax |
|
| Email |
dr_harimohan@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malaviya Government Ayurved College Udaipur |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malaviya Government Ayurved College Udaipur |
| Address |
Madan Mohan Malaviya Government Ayurved College Udaipur
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 Mukesh Kumar Sharma |
Madan Mohan Malaviya Government Ayurved College Udaipur |
OPD No 1
PG Department of Shalya tantra
Associated group of hospitals
Madan Mohan Malaviya Government Ayurved college Udaipur
PIN 313001
Udaipur
RAJASTHAN |
8769491286
dr.m.k.sharma9191@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,M.M.M. Govt.Ayurved College,Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E116||Type 2 diabetes mellitus with other specified complications. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Betadine ointment | It will be administered topically,at the dosage of 3gm,od for the duration of 1 months | | 2 | Intervention Arm | Procedure | - | avacUrNanam, अवचूरà¥à¤£à¤¨à¤®à¥ | (Procedure Reference: Susrurtha samhitha, Procedure details: churna will be applied over ulcer for 24 hrs and changed daily.)
(1) Medicine Name: Panchwalkal kwath, Reference: Sharangdhara samhitha, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 20(g), Frequency: od, Duration: 1 Months(2) Medicine Name: Katphaladi avachurna, Reference: Vangsena, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Duration: 1 Months |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)patients suffering from signs and symptoms of dusta vrana
2)wagner grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
1)below 20 yrs and above 70 yrs
2)wagner grade greater than 2
3)patients suffering from HIV,syphilitic ulcers and tubercular ulcers. |
|
|
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 in signs & symptoms of diabetic ulcer
2)wound area,exudate quantity,pain & odor will be analysed after treatment. |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Improvement in signs & symptoms of diabetic ulcer
2)wound area,exudate quantity,pain & odor will be analysed after treatment. |
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/07/2023 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a multiple arm,parallel group,active control group study.In this study group A 15 patients will be administered with betadine ointment and group B 15 patients will be administered with panchwalkal kwath and katphaladi avachurna. |