Health Condition 1: M056- Rheumatoid arthritis with involvement of other organs and systems
Conditions
Interventions
Intervention1: Ayurveda along with Placebo Methotrexate: After randomization, 109 subjects will be administered with Ayurveda formulations along with Placebo methotrexate for a period of 36 weeks, wit
Sponsors
Central Council for Research in Ayurvedic Science CCRAS
Eligibility
Inclusion criteria
Inclusion criteria: 1) Adult male or female aged between 18 and 65 years, inclusive. 2) Expected to survive more than or equal to 2 years from their inclusion in the protocol. 3) Able to give informed consent and able to read and/or understand instructions in English, Tamil, Malayalam, Kannada, Hindi, Marathi. 4) History of symptoms of RA for greater than 7 years and meets the 2010 ACR/EULAR diagnostic criteria at the time of study entry . 5) Rheumatoid Factor positivity or Anti-CCP positivity. 6). Active disease as defined by fulfillment of the following criteria at 2 visits that are at the most four weeks apart (i.e., at screening and baseline visits): At least 9 of 68 joints assessed as painful or tender on motion. 7) Functional RA classes I, II, or III according to the 1991 ACR classification criteria. Functional RA class IV patients will be permitted if they are not wheelchair or bed bound.
Exclusion criteria
Exclusion criteria: 1. History of an acute inflammatory joint disease as defined by ACR/EULAR criteria other than RA which might interfere with the evaluation of the patientâ??s RA in this study (e.g., SLE, dermatomyositis/polymyositis,reactive arthritis, ankylosing spondylosis, vasculitis). 2. Significant symptomatic osteoarthritis. 3. Acute major trauma to joints within 1 year of study entry such that the joint is fused or non-functional. 4. Previous classic, complete Ayurvedic treatment for RA in the past 6 months, or have used OTC Ayurveda products within 1 month of entry into the study. 5. Currently enrolled in another clinical trial or received an investigational drug within 3 months(or 5 halflives, whichever is longer) prior to entry in the study. 6. Treatment with intra-articular corticosteroid injections in joint within 4 weeks of study entry. 7. Treatment with leflunomide (Arava) within 4 months before intake into study. 8. Previous treatment with methotrexate (greater than 4 doses). 9. Treatment with biologic or targeted synthetic DMARDS within the periods listed below before their baseline visit. 10. Treatment with any immunosuppressive agent (e.g., Azathioprine, Cyclosporine, etc.) within one month of study entry. 11. Chronic infections or a previous infection including intestinal ova and parasites requiring antimicrobial therapy within 1 month of study entry. 12. Concomitant disorders (e.g., diabetes mellitus, hypertension) which are poorly controlled. 13. Cardiac failure (stage III or IV according to the classification of the New York Heart Association, NYHA). 14. Uric acid >11mg/dL or well documented episode of gout according to ACR criteria for gout. 15. Impaired renal function, as shown by serum creatinine 1.5 times above the ULN of the laboratory. 16. Active liver disease OR previous liver disease that has not completely resolved, as shown by serum levels of alkaline phosphatase >2 times lab ULN; SGPT (ALT) >3 times the ULN of the lab; and/or a total bilirubin level less than 2.0 mg/dl 17. Active Hepatitis B or Hepatitis C positive by ELISA; HIV positive per previous screening. 18. Active Tuberculosis (TBC). Note. Can be treated and then started on study. 19. History of cancer or lymphoproliferative disease in the past 5 years. 20. White blood cell count less than 2000/ml, platelet count less than 100, 000/ml, or hemoglobin less than 8 g/L (5.27 mmol/L). If WBC less than 2000/ml but PMN greater than 1000, subject may still be included. 21. Any condition that would, in the investigators opinion, compromise the subjects ability to absorb, tolerate, metabolize, or excrete the study medication or could cause unacceptable risk to the patient. 22. History of recent, clinically significant drug or alcohol abuse (eg, drug seeking behaviour which intereferes with family or work), in the past six months. 23. Mental condition rendering the subjects unable to understand the nature, scope and possible consequence of the study. 24. Subject unlikely to comply with protocol (e.g., non-compliance, inability to return for follow-up visits, and likelihood of not completing the study). 25. If the patient requires more than 3 g per day acetaminophen or whose NSAID intake is more than the maximum dose allowed in the package insert. 26. Pregnant. 27. Lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease activity score (DAS 28-C-Reactive protein CRP),The American college Of Rheumatology Response criteria 20%,50%,70%(ACR 20/50/70)ACRTimepoint: the Primary outcome will be assessed at 12th, 24th and 36th week. the secondary outcome will be assessed at oth week and 36th week. | — |
Secondary
| Measure | Time frame |
|---|---|
| American College of Rheumatology Response Criteria 20%,50%, 70%(A CR20/50/70)responses and its components. Immunological response to ayurvedic treatment and cytokine response at selected points during the study To assess the clinical safety(Biochemical parameter viz LFT and KFT adverse effects and ECG) Quality of life measure HAQ-DITimepoint: 8TH,16TH ,24TH AND 36TH WK | — |
Countries
India
Contacts
Public ContactDr Shubhashree M N
Central Ayurveda Research Institute (CARI),
Outcome results
None listed