| CTRI Number |
CTRI/2024/10/075877 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study to see the effect of some Ayurvedic Formulations In The Management Of Dushta Vrana(Infected Wound) |
|
Scientific Title of Study
|
Randomised Controlled Clinical Study To Evaluate The Efficacy Of sariva Ointment And Eusol In The Management Of Dushta Vrana |
| 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 Sumit Dayanand Gaikwad |
| Designation |
Ms Scolar Shalyatantra(Ayurveda) |
| Affiliation |
MAMs SUMATIBHAI SHAH AYURVED COLLEGE HADAPSAR PUNE |
| Address |
OPD No.3 Shalyatantra Department First Floor Sneguruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
7350424346 |
| Fax |
|
| Email |
sumitgaikwad1234.sg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi A Kale |
| Designation |
MD PhD Associate Professor |
| Affiliation |
MAMs Sumatibhai Shah Ayurved MAhavidyalaya Malwadi Hadapsar Pune |
| Address |
OPD No3 Shalyatantra Department First Floor Sneguruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9822244893 |
| Fax |
|
| Email |
drrakale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi A Kale |
| Designation |
MD PhD Associate Professor |
| Affiliation |
MAMs Sumatibhai Shah Ayurved MAhavidyalaya Malwadi Hadapsar Pune |
| Address |
OPD No3 Shalyatantra Department First Floor Sneguruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9822244893 |
| Fax |
|
| Email |
drrakale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sane Guruji Aarogya Kendra Malwadi Hadapsar Pune 411028
Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Sane guruji Aarogya Kendra Malwadi Hadapsar pune |
| Address |
opd no 3 shalyatantra department sane guruji Aarogya kendra hadapsar pune 411028 Maharashtra 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 Sumit Dayanand Gaikwad |
Sane Guruji Aarogya Kendra |
OPD No3 Shalyatantra Department First Floor Sneguruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA |
7350424346
sumitgaikwad1234.sg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE COMMIT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T75||Other and unspecified effects of other external causes. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sariva Ointment, Reference: Eusol, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: In Yog Ratnakar Sariva mula has been explained as sarva vrana shodhak | | 2 | Comparator Arm (Non Ayurveda) | | - | Eusol | Eusol Topical Dosage Drava Dose(NA),Frequency:OD,Bhaishajya kal:Adhobhakta,Duration:15 days,Anupan:No,Eusol is a desloughing agent |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diabetic wound
irrespective of gender
Bed sores
Post surgical infected wounds
wound size from 2-2 up to 10-10 com |
|
| ExclusionCriteria |
| Details |
Gangrenous wounds
Neoplastic ulcers
other associated disorders
Liver Failure
Burn
Immunosupressed patient. |
|
|
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 |
Study efficacy of Sariva Ointment in the Management of Dushta vrana(Infected Wound)
in terms of reducing signs and symptoms of Dushta Vrana(Infected wound) |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compare the efficacy of sariva ointment & Eusol in the Management of Dushta Vrana(Infected Wound)
To evaluate effect of sariva ointment in terms of reduction in vrana strava vrana gandha vedana
To evaluate the adverse effect of sariva ointmnet dressing during treatment |
15 days |
|
|
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 |
|
Date of First Enrollment (India)
|
05/11/2024 |
| 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 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
|
Wound is inseparable part of surgery.it contributes almost 95% of surgery. It is obivious that focus of research is more on wound healing as prevalence of infection of wound is15.03 per1000. Ayurveda Acharyas has given many treatments for the management of of vrana . they told different therapies for shodhan and ropan of vrana. it also add another plant medicine in the management of dushta vrana if it works effectively. |