| CTRI Number |
CTRI/2018/04/013090 [Registered on: 06/04/2018] Trial Registered Prospectively |
| Last Modified On: |
05/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Other (Specify) [PANCHAKARMA THERAPY (VIRECHANA)] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic management of skin disease |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL TRIAL ON DANTI VIRECHANA YOGA IN THE MANAGEMENT OF VICHARCHIKA |
| Trial Acronym |
VICHARCHIKA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHAHIN PATHAN |
| Designation |
2ND YR MD SCHOLAR |
| Affiliation |
Associate Professor and HOD of Panchkarma Department. |
| Address |
PARUL INSTITUTE OF AYURVEDA PARUL UNIVERSITY LIMDA WAGHODIA VADODARA GUJARAT 391760
PARUL INSTITUTE OF AYURVEDA PARUL UNIVERSITY LIMDA WAGHODIA VADODARA GUJARAT 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9106758309 |
| Fax |
|
| Email |
rohinirakesh2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohini Salve |
| Designation |
Reader |
| Affiliation |
Associate Professor and HOD of Panchkarma Department. |
| Address |
PARUL INSTITUTE OF AYURVEDA PARUL UNIVERSITY LIMDA WAGHODIA VADODARA GUJARAT 391760
PARUL INSTITUTE OF AYURVEDA PARUL UNIVERSITY LIMDA WAGHODIA VADODARA GUJARAT 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9824337785 |
| Fax |
|
| Email |
rohinirakesh2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHAHIN PATHAN |
| Designation |
2ND YR MD SCHOLAR |
| Affiliation |
Parul Institute of Ayurveda,PARUL UNIVERSITY |
| Address |
PARUL INSTITUTE OF AYURVEDA PARUL UNIVERSITY LIMDA WAGHODIA VADODARA GUJARAT 391760
PARUL INSTITUTE OF AYURVEDA PARUL UNIVERSITY LIMDA WAGHODIA VADODARA GUJARAT 391760
GUJARAT
391760
India |
| Phone |
9106758309 |
| Fax |
|
| Email |
drspkhan241@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute Of Ayurved and Hospital |
|
|
Primary Sponsor
|
| Name |
Department Of Panchkarma |
| Address |
PARUL INSTITUTE OF AYURVEDA PARUL UNIVERSITY LIMDA WAGHODIA VADODARA GUJARAT 391760 |
| 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 |
| SHAHIN PATHAN |
PARUL INSTITUTE Of AYURVED AND HOSPITAL |
Room No.113 Panchkarma Department PARUL AYURVEDA HOSPITAL PARUL UNIVERSITY LIMDA WAGHODIA VADODARA GUJARAT 391760 OPD NO 113
Vadodara
GUJARAT |
9106758309
drspkhan241@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
suffering from vicharchika, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DANTI VIRECHANA YOGA |
3 gms OF DANTI VIRECHANA YOGA WILL BE GIVEN AFTER ATTAINING SAMYAK SNEHA LAKSHANAS OVER PATIENTS ON THE DAY OF VIRECHANA KARMA for one day through oral route.
|
| Comparator Agent |
TRIVRUT VIRECHANA YOGA |
3 gms OF TRIVRUT VIRECHANA YOGA WILL BE GIVEN AFTER ATTAINING SAMYAK SNEHA LAKSHANAS OVER PATIENTS ON THE DAY OF VIRECHANA KARMA for one day through oral route
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
DIAGNOSED AS VICHARCHIKA
PATIENTS FIT FOR VIRECHANA KARMA |
|
| ExclusionCriteria |
| Details |
LACTATING AND PREGNANT WOMEN
LESIONS WITH SECONDARY INFECTIONS
PATIENTS WHO ARE UNFIT FOR VIRECHANA KARMA
SUFFERING FROM ANY SYSTEMIC DISORDERS |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvising general condition of patients by decrease in itching, discharge and many other symptoms of vicharchika |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| along with improving the diseased condition it helps in overall purification of body with small doses of formulations used. |
relieve in symptoms accounting upto 50-60% change |
|
|
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 |
|
Date of First Enrollment (India)
|
10/04/2018 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
generally for inducing virechana karma, trivrut yoga is in practice. in clasics danti yoga is mentioned as virechaka yoga in the management of kustha. however, its utility as virechaka yoga in the management of vicharchika is not explored. therefore, there is a need to validate the utility of danti as virechaka yoga in the management of vicharchika. |