Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
Conditions
Interventions
Intervention1: cap 301: cap 301 500mg orally three times a day for 6 weeks
Control Intervention1: nil: nil
Sponsors
central council for research in unani medicine
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of either sex in the age group 18-65 years. 2.Patients having Waja‘al-Maf ?sil (Rheumatoid arthritis) as defined by the following ACR-EULAR criteria 1) Definite clinical synovitis (pain, swelling, tenderness) in at least 1 joint 2) Absence of an alternative diagnosis for the observed synovitis (arthritis) 3) A total score of at least 6 from the individual scores in 4 domains: a. Number and site of involved joints (range 0-5) b. Serological abnormalities (range 0-3) c. Elevated acute-phase reactants (range 0-1) d. Duration of symptoms (range 0-1) 3. Anti-CCP positive patients.
Exclusion criteria
Exclusion criteria: 1.Rheumatoid arthritis with extra-articular manifestations, joint deformities, and advanced radiological lesions (e.g. joint subluxation and collapse). 2.Obese subjects (BMI =30) 3.History or clinical evidence of any systemic inflammatory condition other than RA such as, juvenile chronic arthritis, spondyloarthropathy, IBD, psoriatic arthritis, active vasculitis, or gout that may interfere with evaluation. 4.History or clinical evidence of any serious systemic illness, DM, TB, HIV infection etc 5.Are currently receiving or have received intra-articular treatment (e.g., corticosteroids or hyaluronic acid), oral or parenteral corticosteroids, or NSAIDs within 2 weeks of study entry and DMARDs or IFN therapy within 4 weeks prior to study entry or are anticipated to require IFN therapy during the study. 6.Screening laboratory test values, including S. Creatinine, BUN, S. Bilirubin outside the reference range, and SGOT, SGPT raised >2.5 times the U.L.N. 7.History of hypersensitivity to study drug or any of its ingredients. 8.Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| improvement in Disease Activity Score in 28 Joints (DAS28) Timepoint: improvement in Disease Activity Score in 28 Joints (DAS28) at baseline,2nd week,4th week,6th week | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of Response to Treatment (EULAR Response Criteria based on DAS28Timepoint: day 1 & 45th day | — |
Countries
India
Contacts
Public ContactDr Huma
Regional research institute of unani medicine
Outcome results
None listed