NCT02390349已完成不适用
"CuraMed" and "Curamin" in Osteoarthritis
EuroPharma, Inc.1 个研究点 分布在 1 个国家目标入组 179 人开始时间: 2015年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- Effect of Curamin and Curamed on joint pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
研究概览
简要总结
This randomized, placebo-controlled study evaluates the effects of CuraMed ® (BCM-95 ®) and Curamin ® in the treatment of osteoarthritis. One group will receive CuraMed, one group will receive Curamin and one group will receive placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of degenerative hypertrophic osteoarthritis of the knee (M17, according to International Classification of Diseases (ICD-10) of bone joints, verified by radiography (Grade 1-3 by Kellgren-Lawrence radiographic grades).
排除标准
- •subjects with inflammatory and any secondary arthritis
- •moderate and severe synovitis (grades 2 and 3)
- •tear of meniscus
- •chronic diseases of the kidneys, liver, gastrointestinal, cardiovascular, endocrine and nervous systems
- •allergic anamnesis and drug intolerance
- •pregnant or nursing
- •history of substance abuse
- •subjects taking non-steroidal anti-inflammatory drugs and analgesics within 2 weeks prior to the study
- •subjects taking glucosamine sulfate, chondroitin sulfate, intra-articular hyaluronate, systemic or intra-articular glucocorticoids within three months prior to the study
结局指标
主要结局
Effect of Curamin and Curamed on joint pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: 12 weeks
Effects of Curamin and Curamed on physical performance measures using the Osteoarthritis Research Society International (OARSI) tests of physical function
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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