CTRI/2021/11/038235已完成2 期
Evaluation of efficacy and safety of AHPL/AYTOP/0314 liniment in subjects suffering from Osteoarthritis of Knee(s) - A randomized, open labelled, multi-centric, interventional, comparative, prospective, clinical study
Ari Healthcare Pvt Ltd0 个研究点目标入组 67 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
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) OA confirmed by radiographs and diagnosed according to ACR diagnostic Criteria (clinical and radiological) for the osteoarthritis of the knee(s)
- •2) Subjects with knee joint pain greater than 40 mm (VAS) on weight bearing activities
- •3) Subjects willing to participate in clinical trial and who have read understood and signed informed consent form
- •4) Subjects willing to make all required study visits.
排除标准
- •1) Subjects diagnosed with or suffering from rheumatoid arthritis, gout, pseudo gout, inflammatory arthritis, Pagets disease of bone, chronic pain syndrome, fibromyalgia, or any other major joint disorder.
- •2) Subjects with the history of surgery, including arthroscopy, or major trauma to the study joint in the previous six months before the screening visit.
- •3) Subjects requiring knee arthroplasty within 6 months of screening or anticipating any need for a surgical procedure on the index joint during the study. 4) Subjects with signs of clinically important active inflammation of the study knee joint including redness, warmth and/or a large, bulging effusion with the loss of normal contour at the screening and or baseline visits.
- •5) Subject who used systemic corticosteroids within 2 months of screening, or intra-articular visco-supplementation within the past 3 months.
- •6) Subject with the use of any other investigational drug within 1 month prior to randomization.
- •7) Subjects having history of uncontrolled diabetes mellitus, uncontrolled hypertension, tuberculosis, cancer, HIV or ischemic heart diseases.
- •8) Subjects with known active and serious medical or surgical diseases
- •9) Pregnant or lactating women, or women of childbearing age not using a reliable method of contraception, or women of not child-bearing potential if not permanently sterilized or if not in post-menopausal status from at least two years.
- •10) Subjects with known hypersensitivity to ingredients used in study drugs.
- •11) Subjects with significant abnormal laboratory parameters
研究者
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