| CTRI Number |
CTRI/2024/12/077612 [Registered on: 03/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/11/2024 |
| 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 Formulation in the treatment of Dushta Vrana ( infected wound) |
|
Scientific Title of Study
|
RANDOMISED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF
SAPTAPARNA OINTMENT AND PATHA OINTMENT IN THE MANAGEMENT OF
DUSHTAVRAN |
| 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 Parikshit Prabhuling Korke |
| 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 |
07350424346 |
| Fax |
|
| Email |
parikshitkorke39@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamalakar Gajare |
| Designation |
MS PhD Professor |
| 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 |
07350424346 |
| Fax |
|
| Email |
drgajarekv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamalakar Gajare |
| Designation |
MS PhD Professor |
| Affiliation |
MAMs SUMATIBHAI SHAH AYURVED COLLEGE HADAPSAR PUNE |
| Address |
OPD No.3 Shalyatantra Department First Floor Sneguruji Arogya Kendra Malwadi Hadapsar Pune
MAHARASHTRA
411028
India |
| Phone |
07350424346 |
| Fax |
|
| Email |
drgajarekv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sane Guruji Aarogya Kendra Hadapsar Pune 411028 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Sane guruji Aarogya Kendra Malwadi Hadapsar pune |
| Address |
Department of Shalyatantra Opd No 3 Sane Guruji Aarogya kendra Malwadi 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 Parikshit Prabhuling Korke |
Sane Guruji Aarogya Kendra Malwadi Hadapsar Pune |
OPD No.3 Shalyatantra Department First Floor Sneguruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA |
9834207887
parikshitkorke39@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE MAMs Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T758||Other specified effects of external causes. Ayurveda Condition: DUSHT, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: saptaparna ointment , Reference: Bhavprakash Nighantu, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(mg), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: Saptaparna is a vranashodhak drug | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pathadi Ointment, Reference: Bhavprakash Nighantu, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(mg), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: Patha is the vranashodhak Drug |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
infected wound due to trauma and accident with foul smell and pus discharge
post operative all infected wound
Diabetes Mellitus |
|
| ExclusionCriteria |
| Details |
Gangrenous wound
Neoplastic Ulcer
Burn
Arterial ulcer
Liver Failure
Vericose ulcer |
|
|
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 |
| To study the efficacy of Saptaparna ointment in the Management of Dushta vrana |
15 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe the duration required for achieving shuddha Vrana Avashta
To see the adverse effect of saptaparna ointment dressing during the 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)
|
15/12/2024 |
| 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
|
Infected wound is one of the major contributor to morbidity and mortality. There is infection of wound is dificult to define and no clear rules can be given to distinguish it. from conamination and colonisation as the both of drugs that is sapataparna and patha having great qualities to heal the as of their gunas are explained in samhitas. |