| CTRI Number |
CTRI/2016/04/006808 [Registered on: 08/04/2016] Trial Registered Retrospectively |
| Last Modified On: |
24/03/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A CLINICAL TRIAL TO STUDY THE EFFECTS OF TIKTAKSHIRA BASTI (MEDICATED MILK ENEMA) AND TIKTAKSHIRA PANA (MEDICATED MILK ORALLY) IN PATIENTS WITH SANDHIVATA OSTEOARTHRITIS KNEE. |
|
Scientific Title of Study
|
A CLINICAL STUDY OF TIKTAKSHIRA BASTI IN THE MANAGEMENT OF SANDHIGATA VATA WSR TO OSTEOARTHRITIS KNEE |
| Trial Acronym |
RACE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAM B SHUKLA |
| Designation |
LECTURER M.D. AURVEDA |
| Affiliation |
GOVT. AKHANDANAND AYURVED MAHAVIDHYALAYA AHMEDABAD |
| Address |
6 ISHVARPARK SOCIETY
BHAIRAVNATH CHARRASTA
MANINAGAR
AHMEDABAD
Ahmadabad
GUJARAT
380028
India |
| Phone |
9925505758 |
| Fax |
|
| Email |
ram.ayu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RAM B SHUKLA |
| Designation |
LECTURER M.D. AURVEDA |
| Affiliation |
GOVT. AKHANDANAND AYURVED MAHAVIDHYALAYA AHMEDABAD |
| Address |
6 ISHVARPARK SOCIETY
BHAIRAVNATH CHARRASTA
MANINAGAR
AHMEDABAD
Ahmadabad
GUJARAT
380028
India |
| Phone |
9925505758 |
| Fax |
|
| Email |
ram.ayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RAM B SHUKLA |
| Designation |
LECTURER M.D. AURVEDA |
| Affiliation |
GOVT. AKHANDANAND AYURVED MAHAVIDHYALAYA AHMEDABAD |
| Address |
6 ISHVARPARK SOCIETY
BHAIRAVNATH CHARRASTA
MANINAGAR
AHMEDABAD
Ahmadabad
GUJARAT
380028
India |
| Phone |
9925505758 |
| Fax |
|
| Email |
ram.ayu@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVT AKHANDANAND AYURVED COLLEGE AHMEDABAD |
|
|
Primary Sponsor
|
| Name |
GOVT AKHANDANAND AYURVED COLLEGE AHMEDABAD |
| Address |
GOVT. AKHANDANAND AYURVED COLLEGE,BHADRA, LAL DARAVAJA 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 |
| RAM B SHUKLA |
GOVT. AKHANDANAND AYURVED COLLEGE, AHMEDABAD & GOVT MANIBEN AYURVED HOSPITAL AHMEDABAD |
GOVT. AKHANDANAND AYURVED COLLEGE,BHADRA, AHMEDABAD,GUJARAT
Ahmadabad
GUJARAT |
9925505758
ram.ayu@gmail.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 |
SANDHIVATA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP A TIKTAKSHIRA BASTI
|
GROUP A 45 DAYS (15 DAYS TIKTAKSHIRA BASTI AND 30 DAYS TIKTAKSHIRA PANA)
DOSE OF BASTI:320 ML
ROUTE OF ADMINISTRATION: THROUGH RECTUM
TOTAL DURATION : 45 DAYS
|
| Comparator Agent |
GROUP B TIKTAKSHIRA PANA |
GROUP B 45 DAYS TIKTAKSHIRA PANA
GROUP A 45 DAYS (15 DAYS TIKTAKSHIRA BASTI AND 30 DAYS TIKTAKSHIRA PANA)
DOSE:80 ML
ROUTE OF ADMINISTRATION: ORALLY
TOTAL DURATION : 45 DAYS
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with the classical signs and symptoms of Sandhivata (OA). |
|
| ExclusionCriteria |
| Details |
Patients suffering from uncontrolled diabetes, Psoriatic arthritis, Vatarakta, Amavata, Systemic Lupus Erythematosus (SLE), Bone TB and other serious systemic disorders will be excluded. |
|
|
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 |
Clinical improvement in sign & symptoms of disease, By observing ESR, X-ray findings etc… before & after treatment and compared accordingly, By making standard scale like pain score and improvement in quality of life.
|
45 DAYS |
|
|
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)
|
28/04/2014 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a rendomised, participant blinded, parallel group, active controlled trial to syudy thr roll of Tiktakshira Basti in the management of Sandhivata (Osteoarthritis knee).. There are 2 groups. A and B.In group A Tiktakshira basti will be given in 320 ml fixed dose to 15 patients. In group Tiktakshira Pana will be given in 80 ml fixed dose to 15 patients. |