Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
Conditions
Interventions
Intervention1: Nushkha for Ghatiya: The Unani formulation will be given in powder form 7 gm per day for 8 weeks
Intervention2: UNIM 301: The Unani formulation will be given in 500 gm capsule as 2 caps
Sponsors
Central Council of Research in Unani Medicine
Eligibility
Inclusion criteria
Inclusion criteria: Patients of either sex in the age group 18-65 years. ACR-EULAR criteria with moderate disease activity only. 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 atleast 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 0-3)
Exclusion criteria
Exclusion criteria: Rheumatoid arthritis with extra-articular manifestations, joint deformities, and advanced radiological lesions (e.g., Joint subluxation and collapse). Obese patients BMI 30. 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. History or clinical evidence of any serious systemic illness, DM, TB, HIV infection, etc 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 before study entry or are anticipated to require IFN therapy during the study. Screening laboratory test values, including S. Creatinine, BUN, S. Bilirubin outside the reference range, and SGOT, SGPT raised 2.5 times the ULN. History of hypersensitivity to the study drug or any of its ingredients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome was the change from baseline to week 8 in the signs and symptoms of rheumatoid arthritis based on the Disease Activity Score (DAS) after treatment. Secondary outcomes included the change in the biomarker levels at 8 weeks of treatment.Timepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in serum biomarker levels after Unani intervention and in comparison to healthy participantsTimepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactDr Arsheed Iqbal
CCRUM-Regional Research Institute of Unani Medicine Srinagar
Outcome results
None listed