An Open label, Clinical Validation study to Evaluate the Efficacy and Safety of Unani Pharmacopieal Formulations Majoon-e-Azaraqi and Roghan-e-Surkh in Waja-ul-Mafasil (Rheumatoid Arthritis)

Central Council for Research in Unani Medicine CCRUM New Delhi0 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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•1. Subjects of either sex in the age group 18-65 years.
•2. Subjectshaving total score of >=6/10 in ACR-EULAR criteria for diagnosis of Wajaâ??al-Mafasil (Rheumatoid Arthritis)

•1. Rheumatoid arthritis with extra-articular manifestations, joint deformities, and advanced radiological lesions (e.g. joint subluxation and collapse).
•2. Obese subjects (BMI >=30)
•3. 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.
•4. 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.
•5. Screening laboratory test values, including SGOT, SGPT, ALP, S. creatinine, B. urea, and S. 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.
•6. History of hypersensitivity to study drug or any of its ingredients.
•7. Pregnant and lactating women
•8. H/o Addiction (alcohol, drugs)

发起方

Central Council for Research in Unani Medicine CCRUM New Delhi