| CTRI Number |
CTRI/2015/08/006073 [Registered on: 04/08/2015] Trial Registered Retrospectively |
| Last Modified On: |
23/12/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
"THE CLINICAL TRIAL TO STUDY THE EFFECT OF TWO DRUGS ADRAKAKHANDA AND HARIDRAKHANDA IN THE MANAGEMENT OF SHEETPITTA (URTICARIA)" |
|
Scientific Title of Study
|
"THE CLINICAL STUDY OF ADRAKAKHANDA AND HARIDRAKHANDA IN THE MANAGEMENT OF SHEETPITTA W.S.R. URTICARIA" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MR DHARMESHKUMAR JAYANTILAL PATEL |
| Designation |
M.D.(Ayu) SCHOLAR |
| Affiliation |
GOVT AKHANDANAND AYURVED COLLEGE,AHMEDABAD |
| Address |
VITTHALNAGAR, AT&PO-KAMLI, TALUKA-UNJHA, DIST-MAHESANA, STATE-GUJARAT, INDIA.
Mahesana
GUJARAT
384140
India |
| Phone |
09925098555 |
| Fax |
|
| Email |
dr.dharmeshpatel@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ASHOK PANDYA |
| Designation |
MD (AYU) |
| Affiliation |
GOVT AKHANDANAND AYURVED COLLEGE,AHMEDABAD |
| Address |
HEAD OF DEPARTMENT, KAYACHIKITSHA DEPARTMENT, GOVT AKHANDANAND AYURVED COLLEGE, BHADRA, AHMEDABAD,
STATE-GUJARAT, INDIA.
Ahmadabad
GUJARAT
380001
India |
| Phone |
09879090959 |
| Fax |
|
| Email |
ashokpandya01@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
MR DHARMESHKUMAR JAYANTILAL PATEL |
| Designation |
M.D.(Ayu) SCHOLAR |
| Affiliation |
GOVT AKHANDANAND AYURVED COLLEGE,AHMEDABAD |
| Address |
VITTHALNAGAR, AT&PO-KAMLI, TALUKA-UNJHA, DIST-MAHESANA, STATE-GUJARAT, INDIA.
Mahesana
GUJARAT
384140
India |
| Phone |
09925098555 |
| Fax |
|
| Email |
dr.dharmeshpatel@ymail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT AKHANDANAND AYURVED COLLEGE, AHMEDABAD AND MANIBEN AYURVED HOSPITAL, AHMEDABAD |
|
|
Primary Sponsor
|
| Name |
GOVT AKHANDANAND AYURVED COLLEGE |
| Address |
GOVT AKHANDANAND AYURVED COLLEGE, BHADRA, AHMEDABAD, 380001 |
| Type of Sponsor |
Government 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 |
| MR DHARMESHKUMAR JAYANTILAL PATEL |
(1) GOVT AKHANDANAND AYURVED HOSPITAL ,AHMEDABAD (2) GOVT MANIBEN AYURVED HOSPITAL, AHMEDABAD |
(1)OPD NO-9 KAYACHIKITSHA OPD,GOVT AKHANDANAND AYURVED COLLEGE AND HOSPITAL,BHADRA, AHMEDABAD 380001
(2)OPD NO-23, GOVT MANIBEN HOSPITAL, BEHIND CIVIL HOSPITAL, ASARVA, AHMEDABAD 380016
Ahmadabad
GUJARAT |
09925098555
dr.dharmeshpatel@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, GOVT AKHANDANAND AYURVED COLLEGE, AHMEDABAD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
SHEETPITTA , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group-A Adrakakhanda |
Orally 6 gram OD for 1 month |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
The patients will be selected on the basis of classical sign and symptoms of SHEETPITTA described in ayurved classics like....
Varti Damshta Samsthana Shotha, Kandu, Toda, Vidaha, Mandala, Kshanikotpattivinash. |
|
| ExclusionCriteria |
| Details |
Disease like
Giant urticaria,
Angioedema,
Diabetes mellitus,
T.B.,
and other systemic disorder which leads fatal condition for patient. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| All the signs and symptoms of Sheetpitta will be assigned score depending upone their severity to assess the effect of the drugs at the time of Before treatment and After treatment. |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIl |
NIL |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/03/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomised, Participant blinded, parallel group, active controlled trial to compare the efficacy of Adrakakhanda in the Dose of 6 gram OD with vehicle of Usnodaka for the duration of 1 month in 17 Patients of Sheetpitta and Haridrakhanda in the Dose of 6 gram OD with vehicle of Usnodaka for the duration of 1 month in 17 Patients of Sheetpitta will be conducted in India. |