| CTRI Number |
CTRI/2018/02/012115 [Registered on: 23/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
22/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Ayurveda
Other (Specify) [BIOPURIFICATIONAL] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Management of Rheumatoid arthritis through Panchakarma therapy |
|
Scientific Title of Study
|
Virechana karma along with Vaitarana Basti followed by Maha Bhallataka Avaleha in the managementof Amavata w.s.r. to Rheumatoid Arthritis - A Comparative Rondomized Controlled Study |
| Trial Acronym |
CRCS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| No.PGT/7/-A/Ethics/2016-17/3055 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Anup B Thakar |
| Designation |
Head Department of Panchakarma Director of IPGRand RA jamnagar |
| Affiliation |
head of Panchakarma Department |
| Address |
Directors chamber Institute for Post Graduate Teaching And Research in Ayurveda Gujarat Ayurveda University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
02882551212 |
| Email |
anup_thakar@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shiho oikawa |
| Designation |
MD scholar Department of Panchakarma |
| Affiliation |
MD scholar |
| Address |
OPD Room Number 22. Hopital of Institute for Post Graduate Teaching And Research in Ayurveda Gujarat Ayurveda University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9737517756 |
| Fax |
02882551212 |
| Email |
banzai_oikawas@yahoo.co.jp |
|
Details of Contact Person
Public Query
|
| Name |
Shiho oikawa |
| Designation |
MD scholar Department of Panchakarma |
| Affiliation |
MD scholar of Panchakarma Department |
| Address |
OPD Room Number 22. Hopital of Institute for Post Graduate Teaching And Research in Ayurveda Gujarat Ayurveda University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9737517756 |
| Fax |
02882551212 |
| Email |
banzai_oikawas@yahoo.co.jp |
|
|
Source of Monetary or Material Support
|
| department of genetics university of Delhi, South Campus. Benito Juarez Road. New Delhi-110021 |
| IPGT&RA GAU jamnagar GUJARAT AYURVED UNIVERSITY jamnagar 361008 |
|
|
Primary Sponsor
|
| Name |
Institute for Post Graduate Teaching and Research in Ayurved jamnagar |
| Address |
Institute for Post Graduate Teaching and Research in Ayurved Gujarat Ayurved University Jamnagar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Prof Anup B Thakar |
IPGT AND RA Jamnagar |
Department of Panchakarma OPD number 22. Institute for Post Grraduate Teaching and Research in Ayurved Jamnagar
Jamnagar
GUJARAT |
9427776660
anup_thakar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
PATIENTS WHO ARE SUFFERING FROM SYMPTOMS OF AMAVATA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DAS28, Anti-CCP, RA,ACR-EULAR criteria |
Not applicable |
| Intervention |
internal medicaion |
maha bhallataka avaleha, aswagnahda, simhanada guggulu for 12weeks |
| Intervention |
methotorexate |
Methotrexate 7.5mg weekly, supplemented by folic acid 1mg tab for the rest of 5 days orally for 12 weeks. |
| Intervention |
panchakarma internal medicaiton |
Virechana. Vaitaranabasti, Internal medication as maha bhallataka avaleha, aswagandha, simhanada guggulu for 12weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient who is born and grown up in India
2. Willing and able to perticipate in the study
3. Patient having sign and symptoms of Amavata
4. Patinet who has Rheumatoid Arthritis with fullfill Diagnostic criteria(RF, ANTI CCP, ESR)
5. Chronicity less than 7 years
PATIENTS FIT FOR PANCHAKARMA THERAPY
6. PATIENTS WHO IS POSITIVE IN ACR/EULAR TEST AND ACR SCORE |
|
| ExclusionCriteria |
| Details |
(1)Patients having severe systemic illness such as: Cardiac failure.
(2)Patients below 18 year and above 60 years
(3)Pregnant/lactating women
(4)Chronicity more than 7 and more years
(5)Active or chronic hepatitis
(6)Patient born and grownup in other than India
(7)Patient not fit for Panchakarma therapy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in the DAS28-CRP or DAS-ESR
2.Change in the SF-36
3.Change in the Ayurvedic Parameters for Amavata and Agni.
|
84 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluate the efficacy of differenet varieties of ayurvedic treatment in the management of amavata(rheumatoid arthritis) |
RA Factore
Anti-CCP
DAS 28 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
16/02/2018 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
PAPER WILL PUBLISHED AFTER CMPLETING STUDY |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
TO ASSESS THE CLINICAL EFFICACY OF SHODHANA KARMA (VIRECHANA KARMA FOLLOWED BY VAITARANA BASTI ) AND MAHA BHALLATAKA AVALEHA IN THE MANAGEMENT OF AMAVATA (RHEUMATOID ARTHRITIS), AND ALSO SAFETY OF AYURVEDA TREATMENT IN THE DIGESTIVE SYSTEM . HYPOTHESIS ARE SHODHANA THERAPY IS FACILITATE THE EFFICACY OF SHAMANA THERAPY. |