| CTRI Number |
CTRI/2022/07/044160 [Registered on: 20/07/2022] Trial Registered Prospectively |
| Last Modified On: |
19/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Randomized Clinical Trial To assess the effecacy of Aragwadhadi taila in comparison with betadine liquid in management of Dushta vrana |
|
Scientific Title of Study
|
RANDOMIZED CLINICAL TRIAL TO ASSESS THE EFFICACY OF ARAGWADHADI TAILA IN COMPARISON WITH BETADINE LIQUID IN THE MANAGEMENT OF DUSHTA VRANA. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR AMRUTA ARVIND NARKAR |
| Designation |
M S SCHOLAR SHALYA TANTRA |
| Affiliation |
DR D Y PATIL DEEMED TO BE UNIVERSITY |
| Address |
OPD NO 3 DEPARTMENT OF SHALYATANTRA DR D Y PATIL AYURVED COLLEGE AND RESEARCH CENTRE PIMPRI PUNE SANTA TUKARAM NAGAR PIMPRI COLONY PIMPRI CHINCHAWAD.
OPD NO 3 DEPARTMENT OF SHALYATANTRA DR D Y PATIL AYURVED COLLEGE AND RESEARCH CENTRE PIMPRI PUNE SANTA TUKARAM NAGAR PIMPRI COLONY PIMPRI CHINCHAWAD.
Pune
MAHARASHTRA
411018
India |
| Phone |
9967111390 |
| Fax |
|
| Email |
narkaramruta13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANJAY BABAR |
| Designation |
PROFESSOR |
| Affiliation |
DR D Y PATIL DEEMED TO BE UNIVERSITY |
| Address |
OPD NO 3 DEPARTMENT OF SHALYATANTRA DR D Y PATIL AYURVED COLLEGE AND RESEARCH CENTRE PIMPRI PUNE SANTA TUKARAM NAGAR PIMPRI COLONY PIMPRI CHINCHAWAD.
OPD NO 3 DEPARTMENT OF SHALYATANTRA DR D Y PATIL AYURVED COLLEGE AND RESEARCH CENTRE PIMPRI PUNE SANTA TUKARAM NAGAR PIMPRI COLONY PIMPRI CHINCHAWAD.
Pune
MAHARASHTRA
411018
India |
| Phone |
9011035602 |
| Fax |
|
| Email |
sanjaybabar14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR AMRUTA ARVIND NARKAR |
| Designation |
M S SCHOLAR SHALYA TANTRA |
| Affiliation |
DR D Y PATIL DEEMED TO BE UNIVERSITY |
| Address |
OPD NO 3 DEPARTMENT OF SHALYATANTRA DR D Y PATIL AYURVED COLLEGE AND RESEARCH CENTRE PIMPRI PUNE SANTA TUKARAM NAGAR PIMPRI COLONY PIMPRI CHINCHAWAD.
OPD NO 3 DEPARTMENT OF SHALYATANTRA DR D Y PATIL AYURVED COLLEGE AND RESEARCH CENTRE PIMPRI PUNE SANTA TUKARAM NAGAR PIMPRI COLONY PIMPRI CHINCHAWAD.
Pune
MAHARASHTRA
411018
India |
| Phone |
9967111390 |
| Fax |
|
| Email |
narkaramruta13@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE DEEMED TO BE UNIVERSITY |
|
|
Primary Sponsor
|
| Name |
DR AMRUTA ARVIND NARKAR |
| Address |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE DEEMED TO BE UNIVERSITY |
| 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 AMRUTA ARVIND NARKAR |
DR AMRUTA ARVIND NARKAR |
OPD NO.3 Graud Floor, DEPARTMENT OF SHALYATANTRA DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI Pune 18, SANT TUKARAM NAGAR PIMPRI COLONY PIMPRI CHINCHWAD
Pune
MAHARASHTRA |
9967111390
narkaramruta13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Commitee Meeting |
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
|
| Type |
Name |
Details |
| Intervention |
ARAGWADHADI TAILA |
30 patients will be selected and treated with aragwadhadi taila as per required.
duration of study 15 days
Dose:As Per requirement
Route : Local Application
Duration :15 Days |
| Comparator Agent |
BETADINE LIQUID |
30 patients will be selected and treated with betadine liquid as per required.
duration of study 15 days
Dose: As per requirement.
Route: Local Application
Duration:15 Days |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having sign and symptoms of Dushta Vrana i.e.infected wound.
2.Dushta Vrana size up to 5×5cms (LxB)
3.Patients of either sex will be selected.
4.The patients of age group 19 - 70 years
|
|
| ExclusionCriteria |
| Details |
1.Anaemic patient Hb < 10 gm
2.Malnourished patient (as per age, height and weight proportion)
3.Bleeding disorders (increased B.T and C.T)
4.Patient with septicemia
5.The patients suffering from systemic disease such as AIDS, Tuberculosis, Uncontrolled Diabetes mellitus, Hepatitis-B, Malignancy, Vericose ulcer, Deep vein thrombosis, Neurogenic ulcer, Leukemia, etc.
6.Any congenital diseases or abnormalities.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Dushta vrana (infected wound) has been explained as a stage of vrana in many classical texts. Also, Dushta vrana (infected wound) has been mentioned as a type of vrana (wound).
2)To evaluate the eshtablish safer, cost-effective aragwadhadi taila in the management of dushta vrana (infected wound) |
15 Days of study (0,5,10,15 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Aragwadhadi Taila is effective management of dushta vrana |
15 days of study (0,5,10,15) |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
25/07/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/07/2022 |
| 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
|
aim of the study will be to give ayurvedic treatment to diseased patient to improve his / her condition and we can give his / her cheap, safe side effect free management. The trial will be conducted on 60 patients for follow up of 0,5,10,15 days and doses of drug as per required once a day for 15 days with 4 follow up (0,5,10,15 days ) |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
aim of the study will be to give ayurvedic treatment to diseased patient to improve his / her condition and we can give his / her cheap, safe side effect free management. The trial will be conducted on 60 patients for follow up of 0,5,10,15 days and doses of drug as per required once a day for 15 days with 4 follow up (0,5,10,15 days ) |