| CTRI Number |
CTRI/2024/11/076553 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Trial To Study Effect Of Ayurvedic Lepa In Management Of Dustha Vrana With Reference to Infected Wound |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial To Study The Efficacy Of Ashwagandhadi Lepa In The Management Of Dushtavrana W.S.R To Infected Wound |
| 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 Sagar Yashvant Patil |
| Designation |
MS Shalyatantra Scholar |
| Affiliation |
Dr VJD Gramin Ayurved Mahavidyalaya |
| Address |
OPD no 18 Dr VJD Gramin Ayurved Mahavidyalaya Near Renuka Mata mandir Patur Taluka Patur District Akola State Maharashtra Country India
Dr VJD Gramin Ayurved Mahavidyalaya Near Renuka Mata mandir Patur Taluka Patur District Akola State Maharashtra Country India
Akola
MAHARASHTRA
444501
India |
| Phone |
8268579493 |
| Fax |
|
| Email |
dspatil703@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh B Belorkar |
| Designation |
Associate Professor |
| Affiliation |
Dr VJD Gramin Ayurved Mahavidyalaya |
| Address |
Dr VJD Gramin Ayurved Mahavidyalaya Near Renuka Mata mandir Patur Taluka Patur District Akola State Maharashtra Country India
Dr VJD Gramin Ayurved Mahavidyalaya Near Renuka Mata mandir Patur Taluka Patur District Akola State Maharashtra Country India
Akola
MAHARASHTRA
444501
India |
| Phone |
7972681655 |
| Fax |
|
| Email |
ganeshbelorkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganesh B Belorkar |
| Designation |
Associate Professor |
| Affiliation |
Dr VJD Gramin Ayurved Mahavidyalaya |
| Address |
Dr VJD Gramin Ayurved Mahavidyalaya Near Renuka Mata mandir Patur Taluka Patur District Akola State Maharashtra Country India
Dr VJD Gramin Ayurved Mahavidyalaya Near Renuka Mata mandir Patur Taluka Patur District Akola State Maharashtra Country India
Akola
MAHARASHTRA
444501
India |
| Phone |
7972681655 |
| Fax |
|
| Email |
ganeshbelorkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalyatantra,Dr VJD Gramin Ayurved Mahavidyalaya,Patur,Tal Patur,Dist Akola,Maharashtra, India Pin 444501 |
|
|
Primary Sponsor
|
| Name |
Department of Shalyatantra Dr VJD Gramin Ayurved Mahavidyalaya Patur |
| Address |
Dr VJD Gramin Ayurved Mahavidyalaya Near Renuka Mata mandir Patur Taluka Patur District Akola State Maharashtra Country 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 Sagar Yashvant Patil |
Dr VJD Gramin Ayurved Mahavidyalaya Patur |
Dr VJD Gramin Ayurved Mahavidyalaya Near Renuka Mata mandir Patur Taluka Patur District Akola State Maharashtra Country India
Akola
MAHARASHTRA |
8268579493
dspatil703@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr VJD Gramin Ayurved Mahavidyalaya,Patur,Akola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharagdhar Samhita Madhyamgram khand, Procedure details: All ingredients of Ashwagandhadi Lepa will be taken in equal quantity and mixed it with water)
(1) Medicine Name: Ashwagandhadi Lepa, Reference: Ashtang Hrudyam uttarstan, Route: Topical, Dosage Form: Lepa Churna, Dose: 50(g), Frequency: bd, Duration: 21 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Povidine iodine | It is best antiseptic |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient having age between 18 to 50 years.
Patients irrespective of gender, economic class, caste, religion.
Patient having sign and symptoms of Dushtavrana having area less then length 5 x 5 & max depth 5 mm will be randomly selected |
|
| ExclusionCriteria |
| Details |
Known cases of HIV, Hepatitis B, Diabetes mellitus, any systemic disease.
Patients suffering from wounds like. Tubercular Ulcers,Venous Ulcers, Leprotic Ulcer
Malignant Ulcers
Burns, etc.
• Wounds having excessive loss of Tissues i.e. wound include bone, and tendon injury,exposed bone |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in Pain,Discharge,smell of infected wound |
Decrease in Pain,Discharge,smell of infected wound |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in overall symptoms |
18 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
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2024 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Not yet recruiting |