Health Condition 1: M069- Rheumatoid arthritis, unspecified
Conditions
Interventions
Intervention1: Habb-e-Mafasil: 2 pills (500mg each) thrice daily orally to be taken with water after meals for 12 weeks
Intervention2: Zamad-e-Muhallil: Powder QS twice daily locally to be applied luk
Sponsors
Central Council for Research in Unani Medicine CCRUM New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex in the age group 18-65 years. 2. Patients having Wajaul Mafasil (RA) as defined by the following ACR-EULAR criteria: Definite clinical synovitis (pain, swelling, tenderness) in at least 1 joint 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: Number and site of involved joints (range 0-5) Serological abnormalities (range 0-3) Elevated acute-phase reactants (range 0-1) Duration of symptoms (range 0-1)
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 ULN. 7. History of hypersensitivity to study drug or any of its ingredients. 8. Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the efficacy of study drugs will be assessed on the basis of improvement in symptoms i.e. VAS (0-100 mm) for joint pain and DAS28 (0-10) for clinical disease activity.Timepoint: At every 2 weeks, i.e. at days 14, 28, 42, 56, 70 and on 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Haematological and biochemical assessment for safety assessmentTimepoint: At baseline and after 12 weeks | — |
Countries
India
Contacts
Public ContactDr Pradeep Kumar
Central Council for Research in Unani Medicine (CCRUM)
Outcome results
None listed