Health Condition 1: M048- Other autoinflammatory syndromes
Conditions
Interventions
Intervention1: Safoof-e-Ghati, Unani compound classical formulation: this patient group will be given Unani formulation Safoof-e-Ghatiya is classical unani formulation composed of three drugs as Zanja
Sponsors
Ministry of AYUSH, Government of India
Regional Research Institute of Unani MedicineRRIUM CCRUM Srinagar
Eligibility
Inclusion criteria
Inclusion criteria: Patients of either sex in the age group 18-65 years. Patients having Waja‘al-Maf ?sil (Rheumatoid arthritis) as defined by the following ACR-EULAR criteria (Annexure IV)i.e., 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)
Exclusion criteria
Exclusion criteria: Rheumatoid arthritis with extra-articular manifestations, joint deformities, and advanced radiological lesions (e.g. joint subluxation and collapse). Obese subjects (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 prior to 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 study drug or any of its ingredients. Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relief in signs and symptoms of rheumatoid arthritisTimepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in serum biomarker levels after Unani interventionTimepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactDr Arjumand Shah
Central Council of Research in Unani Medicine, MInistry of Ayush GoI
Outcome results
None listed