CTRI/2018/09/015690招募中2 期
Clinical Validation of a Unani Pharmacopoeial formulation â?? Habb-e-Asgand in Wajaâ??al-MafÄ?sil (Rheumatoid Arthritis)
Central Council for Research in Unani Medicine New Delhi0 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
- 招募中
- 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
- •1.Patients of either sex in the age group 18-65 years.
- •2.Patients having Wajaâ??al-MafÄ?sil (rheumatoid arthritis) as defined by the following ACR-EULAR criteria (Annexure IV):
- •3.Definite clinical synovitis (pain, swelling, tenderness) in at least 1 joint
- •4.Absence of an alternative diagnosis for the observed synovitis (arthritis)
- •5. A total score of at least 6 from the individual scores in 4 domains:
- •6.Number and site of involved joints (range 0-5)
- •7. Serological abnormalities (range 0-3)
- •8. Elevated acute-phase reactants (range 0-1)
- •9. Duration of symptoms (range 0-1)
排除标准
- •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. 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.
- •6. Screening laboratory test values, including S. Creatinine, BUN, S. Bilirubin outside the reference range, and SGOT, SGPT raised >2 times the ULN, that, in the opinion of the investigator, could pose an unacceptable risk to the participant.
- •7. History of hypersensitivity to study drug or any of its ingredients.
- •8 Pregnant and lactating women
- •9. H/o Addiction (alcohol, drugs)
研究者
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