CTRI/2020/03/024187
Not yet recruiting
Phase 2
A Randomized, Active-Controlled, Assessor-Blinded, Parallel Group Clinical Study to evaluate the safety and efficacy of Qurs-e-Mafasil in the Management of Wajaâ??al-MafÄ?á¹£il (Rheumatoid Arthritis) - RCT RA
ational Research Institute of Unani Medicine for Skin Disorders Hyderabad0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: M959- Acquired deformity of musculoskeletal system, unspecified
- Sponsor
- ational Research Institute of Unani Medicine for Skin Disorders Hyderabad
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients of any sex in the age group 35\-55 years
- •Patients diagnosed with Wajaâ??al\-MafÄ?á¹£il (Rheumatoid arthritis) on the basis of 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\)Achievement of a total score of 6 or greater(of a possible 10\) 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
- •Patients aged \<35 years or \>55 years
- •Rheumatoid arthritis with extra\-articular manifestations, joint deformities, and advanced radiological lesions (e.g. joint subluxation and collapse)
- •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
- •Currently receiving or have intra\-articular treatment (e.g. corticosteroids, or NSAIDS within 2 weeks of study entry and DMARDs or IFN therapy within 4 wks prior to study entry or are anticipated to require IFN therapy during study
- •History or clinical evidence of Gastritis/ Peptic Ulcer Disease/ Renal Impairment
- •History of hypersensitivity to study drug or any of its ingredients
- •Pregnant or Lactating Women
- •Hypertensive and Obese Subjects (BMI\>\=30\)
- •H/o Addiction (alcohol, drugs)
- •Significant Pulmonary/Cardiovascular/Hepato\-renal Dysfunction
Outcomes
Primary Outcomes
Not specified
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