| CTRI Number |
CTRI/2017/02/007771 [Registered on: 03/02/2017] Trial Registered Retrospectively |
| Last Modified On: |
02/02/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of khadirastak kwatha and somraji taila (external application) in the treatment of vicharchika (dry eczema) |
|
Scientific Title of Study
|
A CLINICAL STUDY OF KHADIRASTAK KWATHA AND SOMRAJI TAILA (EXTERNAL APPLICATION) IN THE MANAGMENT OF VICHARCHIKA(DRY ECZEMA) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhay K Sharma |
| Designation |
M.D.(Ayurved) Scholar |
| Affiliation |
Government Akhandanand Ayurved College and Hospital Ahmedabad |
| Address |
Kayachikitsa Department Government Akhandanad Ayurved College and Hospital
Not applicable
Ahmadabad
GUJARAT
380001
India |
| Phone |
9889309780 |
| Fax |
|
| Email |
abhaysharma8585@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashok S Pandya |
| Designation |
M D Professor and HOD |
| Affiliation |
Government Akhandanand Ayurved College and Hospital Ahmedabad |
| Address |
Kayachikitsa Department Government Akhandanad Ayurved College and Hospital
Not applicable
Ahmadabad
GUJARAT
380001
India |
| Phone |
8690866863 |
| Fax |
|
| Email |
rt8arti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhay K Sharma |
| Designation |
M.D.(Ayurved) Scholar |
| Affiliation |
Government Akhandanand Ayurved College and Hospital Ahmedabad |
| Address |
Kayachikitsa Department Government Akhandanad Ayurved College and Hospital
Ahmadabad
GUJARAT
380001
India |
| Phone |
9889309780 |
| Fax |
|
| Email |
abhaysharma8585@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room number 9 kayachikitsa department government akhandanand ayurved college and hospital bhadra and room number 23 post graduate department of shri maniben ayurved hospital asarva ahmedabad gujarat |
|
|
Primary Sponsor
|
| Name |
Government Akhandanand Ayurved college and Hospital |
| Address |
Near bhadra court lal darwaja 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 |
| Dr Abhay k sharma |
Government Akhandanad Ayurved College and Hospital. |
Room number 9 kayachikitsa department lal darwaja bhadra ahmedabad 380001
Ahmadabad
GUJARAT |
9889309780
abhaysharma8585@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVT AKHANDANAND AYURVED COLLEGE AND HOSPITAL AHMEDABAD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
VICHARCHIKA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
khadirastak kwath |
Group A 15 patients of group A will be treated with khadirastak kwath in a dose of 40 ml BD for one and half month |
| Comparator Agent |
somraji taila |
Group B patients of this group will be treated with Somraji taila as an external applicant in a dose 1ml per 1cm square of leison along w with khadirastak kwath in a dose of 40ml BD for one and half month |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having classical sign and symptoms of vicharchika like Kandu Pidika Shyavavarna etc of duration less than 6 months |
|
| ExclusionCriteria |
| Details |
Patients not full filling the age criteria.
patients having serious illnesses like AIDS HTN Diabetes Tuberculosis etc.
vicharchika as complication of other skin diseases. |
|
|
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 vicharchika will be assigned score depending upon their severity to assess the effect of the drug at the time of before treatment and after treatment. |
1.5 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
19/07/2016 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
"None yet" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomised, Participants blinded, Parallel group, Active controlled trial to evaluate the efficacy of Khadriastak Kwatha as internal medicine in a dose of 40ml BD for 6 weeks in 15 patients of vicharchika of group A and To evaluate the efficacy of Khadirastak kwath in a dose of 40 ml BD with Somraji Taila as external applicants in a leison size dependent dose for 6 weeks in 15 patients of Vicharchika of group B. |