| CTRI Number |
CTRI/2019/02/017432 [Registered on: 05/02/2019] Trial Registered Prospectively |
| Last Modified On: |
22/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate the pain relieving effect of medicated enema and medicated purgation in the management of joint pain |
|
Scientific Title of Study
|
A comparative study to evaluate the Rujahara(analgesic) effect of virechana karma and vaitarana basti in Amavata (rheumatoid arthritis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Gupta |
| Designation |
PG scholar |
| Affiliation |
CHAUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN, KHERA DABAR, NEW DELHI |
| Address |
PG DOCTORS HOSTEL, CHOUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN,Panchkarma department room no 231 KHERA DABAR, NEW DELHI
PG DOCTORS HOSTEL, CHOUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN, Panchkarma department room no 231 KHERA DABAR, NEW DELHI
South West
DELHI
110073
India |
| Phone |
9460044624 |
| Fax |
|
| Email |
drdivya.rsg93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishakha R Wetal |
| Designation |
Associate professor |
| Affiliation |
CHOUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN, KHERA DABAR, NEW DELHI |
| Address |
CHOUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN, panchkarma department room no 231 KHERA DABAR, NEW DELHI
CHOUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN, panchkarma department room no 231 KHERA DABAR, NEW DELHI
South West
DELHI
110073
India |
| Phone |
9850804498 |
| Fax |
|
| Email |
vishakhawetal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishakha R Wetal |
| Designation |
Associate professor |
| Affiliation |
CHOUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN, KHERA DABAR, NEW DELHI |
| Address |
CHOUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN,panchkarma department room no 231 KHERA DABAR, NEW DELHI
CHOUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN,panchkarma department room no 231 KHERA DABAR, NEW DELHI
South West
DELHI
110073
India |
| Phone |
9850804498 |
| Fax |
|
| Email |
vishakhawetal@gmail.com |
|
|
Source of Monetary or Material Support
|
| chaudhary brahm prakash ayurveda charak sansthan khera dabar |
|
|
Primary Sponsor
|
| Name |
Choudhary brahm prakash charak ayurveda sansthana |
| Address |
Choudhary brahm prakash charak ayurveda sansthana,khera dabar najafgarh new delhi 110073 |
| 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 |
| divya gupta |
chaudhary brahm prakash ayurveda charak sansthana |
PG DOCTORS HOSTEL CHAUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN panchkarma department room no 231 KHERA DABAR Najafgarh NEW DELHI
110073
South West
DELHI |
7062847624
drdivya.rsg93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee-Choudhary brahm prakash ayurveda charak sansthan |
Approved |
| Institutional Ethics committee-Choudhary brahm prakash ayurveda charak sansthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Vaitarana basti |
Vaitarana basti will be administered for 8 days in the sequence of Yoga basti,450 ml daily |
| Intervention |
Virechana karma with Trivritadi churna |
Virechana karma with Trivritadi churna as per koshtha and Agni In pitta kala 1 day
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinical features of Amavata as described in Madhav Nidan.
Patients between the age group of 21 to 50 years.
Patients fulfilling the 2010 ACR-EULAR criteria for Rheumatoid Arthritis.
|
|
| ExclusionCriteria |
| Details |
Patients having severe crippling bone deformities and severely damaged joint with bed ridden patients.
Patients having any type of Arthropathy such as neoplasm of spine, Gout, Ankylosing spondylitis, Traumatic arthritis and pyogenic osteomyelitis and any other type of arthritis.
Patients having associated Cardiac disease, Tuberculosis, malignant hypertension, Impairment of Liver functions, Impairment of Renal functions, malignancy, HIV-AIDS etc.
Pregnant women and lactating mother.
Patients who develop secondary complication of RA e.g. Pleuro-pericardial diseases
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in DAS28 (disease activity score 28) |
16 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PAIN IN JOINTS(VAS)SCALE |
16 DAY |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
08/02/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a open label parallel group trial comparing the efficacy of Vaitaran basti (medicated enema) and Virechana karma in the management of Amavata (Rheumatoid Arthritis) In one group Vaitaran basti in the dose of 450 ml per day for 8 days will be given. In another group virechana karma will be given. The trial will be conducted in Chaudhary Brahm Prakash Ayurved Charak Sansthan India with primary outcome of improvement in Disease activity score and secondary outcome of improvement in Visual analouge scale . |