CTRI/2020/03/024187尚未招募2 期
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 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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)
排除标准
- •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
研究者
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