| CTRI Number |
CTRI/2021/10/037287 [Registered on: 12/10/2021] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A STUDY OF DURVADYA TAILA (OIL) FOR LOCAL APPLICATION IN THE TREATMENT OF SADYO VRANA (TRAUMATIC WOUND) |
|
Scientific Title of Study
|
SINGLE ARM CLINICAL STUDY OF DURVADYA TAILA LOCAL APPLICATION IN THE MANAGEMENT OF SADYO VRANA (TRAUMATIC WOUND) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR GANESH DNYANDEO KARCHE |
| Designation |
MS SCHOLAR SHALYA TANTRA |
| Affiliation |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 411018 |
| Address |
OPD NO-3 SHALYA TANTRA DEPARTMENT DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 411018
OPD NO-3 SHALYA TANTRA DEPARTMENT DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9765300600 |
| Fax |
|
| Email |
ganeshkarche5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANJAY CHANDRAKANT BABAR |
| Designation |
PROFESSOR AND HOD SHALYA TANTRA |
| Affiliation |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 411018 |
| Address |
OPD NO-3 SHALYA TANTRA DEPARTMENT DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 411018
OPD NO-3 SHALYA TANTRA DEPARTMENT DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9011035602 |
| Fax |
|
| Email |
sanjaybabar14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SANJAY CHANDRAKANT BABAR |
| Designation |
PROFESSOR AND HOD SHALYA TANTRA |
| Affiliation |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 411018 |
| Address |
OPD NO-3 SHALYA TANTRA DEPARTMENT DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 411018
OPD NO-3 SHALYA TANTRA DEPARTMENT DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9011035602 |
| Fax |
|
| Email |
sanjaybabar14@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 411018
DEEMED TO BE UNIVERSITY |
|
|
Primary Sponsor
|
| Name |
DR GANESH DNYANDEO KARCHE |
| Address |
OPD NO-3 SHALYA TANTRA
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 411018 |
| Type of Sponsor |
Other [SELF] |
|
|
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 GANESH DNYANDEO KARCHE |
OPD NO-3 SHALYA TANTRA DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 411018 |
OPD NO-3 SHALYA TANTRA
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 411018
Pune
MAHARASHTRA |
9765300600
ganeshkarche5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T149||Unspecified injury. Ayurveda Condition: SADYOVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: DURVADYA TAILA , Reference: CHAKRADATTA 79, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: DURVADYA TAILA WILL BE GIVEN FOR 15 DAYS FOR LOCAL APPLICATION TWICE A DAY FOLLOW UP WILL BE TAKEN ON 7TH AND 15TH DAY |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) PATIENTS HAVING TRAUMATIC WOUND HAPPENED WITHIN 48 HR
2) WOUND HAVING MAXIMUM AREA NOT EXCEEDING 5CM X 5CM
3) PATIENTS WILL BE TAKEN WITH IRRESPECTIVE OF GENDER
4) PATIENT OF AGE GROUP 18 TO 70 YEARS |
|
| ExclusionCriteria |
| Details |
1) INFECTED/PUS DISCHARGING WOUND
2) UNCONTROLLED DIABETIC MELLITUS
3) SUTURED WOUND
4) WOUND OF VISCERAL AND SPINAL INJURIES |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO STUDY THE EFFECT OF DURVADYA TAILA IN REDUCTION OF WOUND SIZE |
DURVADYA TAILA WILL BE GIVEN ON 0th,7th DAY FOR LOCAL APPLICATION ONCE A DAY
FOLLOW UPS WILL BE ON 7th AND 15th DAY
TOTAL DURATION OF STUDY WILL BE 15 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO STUDY THE ADVERSE EFFECT OF DURVADYA TAILA |
DURVADYA TAILA WILL BE GIVEN ON 0th,7th DAY FOR LOCAL APPLICATION ONCE A DAY
FOLLOW UPS WILL BE ON 7th AND 15th DAY
TOTAL DURATION OF STUDY WILL BE 15 DAYS |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
14/11/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/11/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
THE AIM OF STUDY IS TO SEE THE EFFECTIVENESS OF DURVADYA TAILA LOCAL APPLICATION IN THE MANAGEMENT OF SADYO VRANA (TRAUMATIC WOUND) .THE STUDY WILL BE CONDUCTED WITH 30 PATIENTS SHOWING SIGNS ANS SYMPTOMS OF SADYO VRANA DE WILL BE APPLY DURVADYA TAILA LOCALY ONCE A DAY FOR SEVEN DAYS AND FOLLOW WILL BE DONE ON 7TH AND 15TH DAY AND CONCLUSION WILL BE DRAWN ON THE BASIS OF PROPER STATISTICAL METHODS . |