| CTRI Number |
CTRI/2021/12/038678 [Registered on: 16/12/2021] Trial Registered Prospectively |
| Last Modified On: |
14/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of Sariva moola lepa in Dushta Vrana i.e Infected wound. |
|
Scientific Title of Study
|
“OPEN RANDOMISED CONTROL CLINICAL TRIAL OF EFFICACY OF SARIVAMOOLA LEPA IN DUSHTAVRANA.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Prashant D Date |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College and PG Research Center,Ashta Tal Walwa Dist Sangli |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College
and PG Research Center ,Ashta, Tal Walwa,Dist-Sangli
Hon.Shri Annasaheb Dange Ayurved Medical College
and PG Research Center Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9822706975 |
| Fax |
|
| Email |
drdateprashant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Prashant D Date |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College and PG Research Center, Ashta Tal Walwa Dist Sangli |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College and PG Research Center Ashta Tal Walwa Dist Sangli
Hon Shri Annasaheb Dange Ayurved Medical College
and PG Research Center Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9822706975 |
| Fax |
|
| Email |
drdateprashant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Mansi Machhindra Chavan |
| Designation |
PG Scholar Shalyatantra |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical college And PG Reaserch center ,Ashta Tal Walwa Dist Sangli |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College
and PG Research Center Ashta Tal Walwa Dist Sangli
Hon Shri Annasaheb Dange Ayurved Medical College and PG Research Center Ashta Tal Walwa Dist Sangli Pin code 416301
Sangli
MAHARASHTRA
416301
India
Sangli
MAHARASHTRA
416301
India |
| Phone |
9503012783 |
| Fax |
|
| Email |
mansichavan0611@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate
& Research Center Ashta Tal Walwa Dist Sangli |
|
|
Primary Sponsor
|
| Name |
Hon Shri Annasaheb Dange Ayurvedic Medical college And Post Graduate Reserch Center Ashta |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate
& Research Center Ashta Tal Walwa Dist Sangli |
| Type of Sponsor |
Private 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 |
| Vd Mansi Chavan |
Dhanvantari Hospital Ashta |
Shalyatantra OPD Hon Shri Annasaheb Dange Ayurved Medical College and PG Research Center Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA |
9503012783
mansichavan0611@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Ethical commitee |
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, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Sarivamoola , Reference: Yogratnakar samhita, Route: Topical, Dosage Form: Lepa Churna, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: Intervention is Sarivamoola lepa
Comparator is Povidoine iodine solution
Both will be applied topically twice a day on dushta Vrana i.e. dushta vrana |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient of infected wound included
2.Wound size within 5cm length by 5cm breadth
3.Depth not more than 1cm
|
|
| ExclusionCriteria |
| Details |
1 Age group below 18 years and above 50 years
2 Patients with severe anemia
3 Diabetic wounds
4 Ulcers due to radiation therapy
5 HIV positive/ immunocompromised patients
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sarivamoola lepa is effective as shodhan in dushta Vrana i.e infected wound which will be applied twice daily topically |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Povidone iodine solution is effective in dushta Vrana i.e infected wound which will be applied twice daily topically |
28 days |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
30/12/2021 |
| 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 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
|
Various modern medicines are usd in treatment of Dushta Vrana like betadine, eusol etc. Administration of these formulations leads to various side effects. Ayurvedic formulations are multifunctional as they help in cleaning and healing both.Hence to overcome drawback of modern medicine, ayurvedic formulation Sarivamoola Lepa which helps in shodhan is used on Dushta Vrana. |