A randomized, parallel group, open label, controlled clinical study to evaluate the safety and efficacy of a Unani Pharmacopoeial formulation â?? Habb-e-Baryuma in Wajaâ??al-MafÄ?á¹£il (Rheumatoid Arthritis)

Central Research Institute of Unani Medicine Hyderabad0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Patients of any sex in the age group 35-55 years
•Patients having Wajaâ??al-MafÄ?á¹£il (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)The 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)

•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)
•Obese subjects (BMI >=30)
•History or clinical evidence of Gastritis/ Peptic Ulcer Disease/ Renal Impairment
•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
•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
•History of hypersensitivity to study drug or any of its ingredients
•Pregnant and lactating women
•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

发起方

Central Research Institute of Unani Medicine Hyderabad