| CTRI Number |
CTRI/2024/10/075805 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Observational study to find out the result of various Ayurveda treatment methods used for the managment of Rheumatoid Arthritis. |
|
Scientific Title of Study
|
An Observational study to explore the outcome of multimodal Ayurveda treatment in the management of Rheumatoid Arthritis a Prospective Cohort study. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naveen Kumar |
| Designation |
MD Scholar,Department of Kayachkitsa |
| Affiliation |
All India Institute of Ayurveda |
| Address |
618(Seminar Hall) Department Of Kayachikitsa ,All India Institute Of
Ayurveda Gautampuri Sarita vihar New Delhi South Delhi
India Gautampuri Sarita vihar New Delhi South Delhi
India South DELHI 110076 India |
| Phone |
9971656859 |
| Fax |
|
| Email |
yadavnaveen9971@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr VG Huddar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
621 Department Of Kayachikitsa All India Institute Of Ayurveda
Gautampuri Sarita vihar New Delhi South DELHI India Gautampuri Sarita vihar New Delhi South DELHI India South DELHI 110076 India |
| Phone |
9986697942 |
| Fax |
|
| Email |
drvghuddar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr VG Huddar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
621 Department Of Kayachikitsa All India Institute Of Ayurveda
Gautampuri Sarita vihar New Delhi South DELHI India Gautampuri Sarita vihar New Delhi South DELHI India South DELHI 110076 India |
| Phone |
9986697942 |
| Fax |
|
| Email |
drvghuddar@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda, Mathura Road, Gautam Puri Sarita Vihar, Delhi - 110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
Gautampuri Sarita Vihar New Delhi 110076 |
| 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 Naveen Kumar |
All India Institute of Ayurveda |
OPD no 3 andRoom no 61 6th floor ,Department of Kayachikitsa ,Gautampuri
Sarita vihar New Delhi
South DELHI 110076
India South DELHI |
9971656859
yadavnaveen9971@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) All India Institute of Ayurveda New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M069||Rheumatoid arthritis, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
The patient fulfilling Diagnostic Criteria 2010 ACR (American College of Rheumatology) /EULAR (European League Against Rheumatism) criteria for RA (min. 6/10).
Raised level in one of the following biochemical Investigations RA Factor,CRP,Anti CCP,ESR , Serum Uric Acid.
Patients having classical signs and symptoms of Amavatah & Vatarakta. |
|
| ExclusionCriteria |
| Details |
Patients having severe illness CAD ,respiratory failure, stroke etc.
Patients suffering from pre-existing systemic illnesses- CAD, uncontrolled diabetes mellitus and Hypertension , CKD, Cirrhosis, malignancies- that may jeopardise the treatment outcomes.
Patients taking DMARDs and Biologicals during the intervention period.
Patients having co-existing Autoimmune conditions – SLE, Spondyloarthropathy,
scleroderma .
Pregnant women and lactating mother.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Observing, analyse and documenting Change in CRP , ESR , RA Factor , NLR ,Uric Acid levels along with change in other objective parameters DAS28 SCORE,CDAI.
Observe the Change in Clinical symptomatology of the RA patients.
|
Day 0
Day 15
Day 30
Day 45
Day 60
Day 120
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Observing Change in Qualty of Life of RA affected individuals. |
Day 0
Day 15
Day 30
Day 45
Day 60
Day 120 |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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)
|
10/11/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Rheumatoid Arthritis is a multi-system Polyarthritis connective tissue disorder causing inflammation and erosion of symmetrical smaller and larger joints characterised by pain and stiffness of synovial joints.The worldwide prevalence of the disease is approximately 1%.The disease most often affects the ages between 30 and 50 but recent studies suggests that the disease can begin in any age group.The prevalence of Rheumatoid Arthritis in India is 0.5- 3.8% in women and 0.15 - 1.35 % in men, the ratio of occurrence is 3:1.Ayurveda has mentioned classical signs and symptoms similar to RA along with various treatment principles and procedures using Panchkarma therapies and various formulations .These methods should be observed appropriately and employed in the present time to decrease the burden of disease and prevent related complications of this dreadful disease using holistic approach.Hence this study is planned to observe and document the treatment given by the Physicians in All India Institute of Ayurveda.Observation of change in subjective and objective parameters in the current clinical practise will be documented .This study provide scope for further research areas by paving a way to develop treatment protocols to tackle this dreadful Autoimmune disorder. |