A comparative Clinical Study to evaluate the safety and efficacy of a unani formulation in the Management of Wajaâ??al-MafÄ?á¹£il (Rheumatoid Arthritis)
- Conditions
- Health Condition 1: M959- Acquired deformity of musculoskeletal system, unspecified
- Registration Number
- CTRI/2020/03/024187
- Lead Sponsor
- ational Research Institute of Unani Medicine for Skin Disorders Hyderabad
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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)
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
Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies
Patient not willing to attend treatment schedule regularly
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical assessment will be done at 0, 1, 2, 3 and 4 weeks and the response to treatment will be assessed using the following parameters: <br/ ><br>1) Visual Analogue Scale (VAS) <br/ ><br>2) Disease Activity Score in 28 joints (DAS28)27Timepoint: Clinical assessment will be done at 0, 1, 2, 3 and 4 weeks and the response to treatment will be assessed using the following parameters: <br/ ><br>1) Visual Analogue Scale (VAS) <br/ ><br>2) Disease Activity Score in 28 joints (DAS28)27
- Secondary Outcome Measures
Name Time Method ab investigation and X-rayTimepoint: 0,2, 4 weeks