| CTRI Number |
CTRI/2020/01/022732 [Registered on: 13/01/2020] Trial Registered Prospectively |
| Last Modified On: |
05/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
PRAPOUNDARIKADYA GHRITA IN DUSTA VRANA |
|
Scientific Title of Study
|
A CLINICAL STUDY TO ASSESS THE EFFECTOF PRAPOUNDARIKADYA GHRITA IN THE MANAGEMENT OF DUSTA 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 MUHIT KHAN |
| Designation |
PG SCHOLAR |
| Affiliation |
PARUL INSTITUTE OF AYURVED |
| Address |
PARUL AYURVED HOSPITAL SHALYA TANTRA DEPARTMENT OPD NO.116 P.O. LIMDA PARUL UNIVERSITY VADODARA
GUJARAT
391760
PARUL AYURVED HOSPITAL SHALYA TANTRA DEPARTMENT OPD NO.116 P.O. LIMDA PARUL UNIVERSITY VADODARA
GUJARAT
391760
Vadodara
GUJARAT
391760
India |
| Phone |
9319053483 |
| Fax |
|
| Email |
khan.muhit181@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR HEMANT TOSHIKHANE |
| Designation |
PROFESSOR |
| Affiliation |
PARUL INSTITUTE OF AYURVED |
| Address |
PARUL AYURVED HOSPITAL SHALYA TANTRA DEPARTMENT OPD NO.116 P.O. LIMDA PARUL UNIVERSITY VADODARA
GUJARAT
391760
PARUL AYURVED HOSPITAL SHALYA TANTRA DEPARTMENT OPD NO.116 P.O. LIMDA PARUL UNIVERSITY VADODARA
GUJARAT
391760
Vadodara
GUJARAT
391760
India |
| Phone |
8469496525 |
| Fax |
|
| Email |
drhemantt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MUHIT KHAN |
| Designation |
PG SCHOLAR |
| Affiliation |
PARUL INSTITUTE OF AYURVED |
| Address |
PARUL AYURVED HOSPITAL SHALYA TANTRA DEPARTMENT OPD NO.116 P.O. LIMDA PARUL UNIVERSITY VADODARA
GUJARAT
391760
PARUL AYURVED HOSPITAL SHALYA TANTRA DEPARTMENT OPD NO.116 P.O. LIMDA PARUL UNIVERSITY VADODARA
GUJARAT
391760
Vadodara
GUJARAT
391760
India |
| Phone |
9319053483 |
| Fax |
|
| Email |
khan.muhit181@gmail.com |
|
|
Source of Monetary or Material Support
|
| PARUL AYURVED HOSPITAL SHALYA TANTRA DEPARTMENT OPD NO.116 P.O. LIMDA PARUL UNIVERSITY VADODARA
GUJARAT
391760 |
|
|
Primary Sponsor
|
| Name |
PARUL INSTITUTE OF AYURVED |
| Address |
PARUL AYURVED HOSPITAL P.O. LIMDA PARUL UNIVERSITY VADODARA |
| 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 |
| DR MUHIT KHAN |
PARUL AYURVED HOSPITAL |
PARUL AYURVED HOSPITAL SHALYA TANTRA DEPARTMENT OPD NO.116 P.O. LIMDA PARUL UNIVERSITY VADODARA
GUJARAT
391760
Vadodara
GUJARAT |
9319053483
khan.muhit181@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTINOAL ETHICS COMMITTEE FOR HUMAN RESEARCH, PARUL INSTITUTE OF AYURVED, PARUL UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APLICCABLE |
NOT APLICCABLE |
| Intervention |
PRAPOUNDARIKADYA GHRITA |
PRAPOUNDARIKADYA GHRITA WILL BE APPLY ON DUSTA VRANA
DOSE-AS PER THE VRANA SIZE AND SITE |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of Dushta vrana will be randomly selected irrespective of sex, religion, occupation and socio-economic status.
2.Patients aged between 20 – 70 years.
3.Patients suffering from Dushta vrana and Lakshana’s as per classics.
4.Vrana with the history of one month or more.
|
|
| ExclusionCriteria |
| Details |
1.PATIENTS BELOW 20 YEARS AND ABOVE 70 YEARS OF AGE.
2.PATIENTS WITH DISORDERS LIKE MALIGNANCY, SYPHILIS, TUBERCULOSIS, LEPROSY, etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| OUTCOME WILL BE ASSES ON EVERY 1 WEEK |
ASSESMENT EVERY 1 WEEK,
TOTAL TREATMENT DURATION 4 WEEK |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "31"
Final Enrollment numbers achieved (India)="31" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/01/2020 |
| Date of Study Completion (India) |
23/04/2021 |
| Date of First Enrollment (Global) |
15/01/2020 |
| Date of Study Completion (Global) |
23/04/2021 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
PURPOSE OF TRAIL TO ASSESS THE FAST HEALLING PROPERTY AND EFFECT OF PRAPOUNDARIKADYA GHRITA IN DUSTA VRANA. NULL HYPOTHESIS :-PRAPOUNDARIKADYA GHRITA is not effective in the management of Dusta Vrana. ALTERNATE HYPOTHESIS :-PRAPOUNDARIKADYA GHRITA is effective in the management of Dusta Vrana.
|