CTRI/2024/07/070640尚未招募2 期
A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Safety and Efficacy of a combination of oral and topical Unani Formulations in the Management of Waja‘ al-Maf ?s?il (Osteoarthritis Knee) - NI
ational Research Institute of Unani Medicine for Skin Disorders0 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
- •1.Patients of any sex aged between 40to 65years
- •2.Clinical and Radiographic Knee Osteoarthritis as per the following
- •American College of Rheumatology (ACR) criteria:
- •a. Knee Pain
- •b. Osteophytes on Knee Radiograph, and
- •c. At least 1 of the following 3 criteria:
- •i. Age =40 years
- •ii. Morning Stiffness lasting =30 minutes
- •iii. Crepitus on Active Knee Motion
- •3.Knee OA of Kellgren-Lawrence Grade 1 to 3
- •4.Participants who are able and willing to comply with the protocol and to sign IEC approved ICF
排除标准
- •1.Knee OA of Kellgren-Lawrence grade IV
- •2. Secondary OA, Inflammatory joint diseases (e.g. RA, psoriatic arthritis, gout), or any other type of arthritis
- •3.Patients on long-term steroid treatment
- •4.H/o having received intra-articular knee injection (corticosteroids or hyaluronan), or any investigational drug in the previous one month
- •5.Pregnant or Lactating Women
- •6.Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction
- •7.Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies
研究者
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