Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified Health Condition 2: null- Wajaâ??al-Mafasil (Rheumatoid Arthritis)
Conditions
Interventions
Intervention1: Majun Jograj Gugal and Raughan-e-Malkangani: 1.Majun Jograj Gugal: Dose five grams twice daily orally after meals for a period of 12 weeks
2.Raughan-e-Malkangani: Dose- Quantity suffici
Sponsors
Central Council for Research in Unani Medicine New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: • Patients of either sex in the age group 18-65 years. • Patients having Wajaâ??al-Mafasil (rheumatoid arthritis) as defined by the following ACR-EULAR criteria (Annexure IV): 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, disseminated/ complicated herpes zoster (e.g., multi-dermatomal involvement, ophthalmic zoster, CNS involvement, or post-herpetic neuralgia), HIV infection or any other serious and/ or unstable illness that, in the opinion of the investigator, could constitute a risk when taking study drug or could interfere with the interpretation of data. • 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 SGOT, SGPT, ALP, S. creatinine, B. urea, and uric acid outside the reference range (raised >3 times the ULN) that, in the opinion of the investigator, could pose an unacceptable risk to the participant. • History of hypersensitivity to study drug or any of its ingredients. • Pregnant and lactating women • H/o Addiction (alcohol, drugs)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in signs and symptoms of Wajaâ??al-Mafasil (Rheumatoid Arthritis)Timepoint: 12 WEEKS | — |
Secondary
| Measure | Time frame |
|---|---|
| Haematological and biochemical assessments for safety ï?· Improvement in the feeling of well-being of the patientTimepoint: 12 WEEKS | — |
Countries
India
Contacts
Public ContactDR PRADEEP KUMAR
Central Council for Research in Unani Medicine (CCRUM)
Outcome results
None listed