A Double-blind, Randomized, Parallel Group, Phase III Comparative Study of Turmeric Extract and Placebo to Patients With Mild to Moderate Arthrosis of the Knee and or Hip.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- ADL (Activity of daily living)
研究概览
简要总结
The aim of this study is to test if an extract of Turmeric can alleviate symptoms of osteoarthritis in volunteers with osteoarthritis of the hip and or knee.
详细描述
The included volunteers, who are devided into two groups either placebo or turmeric extract, will be tested using WOMAC questionnaires focussing on pain, stiffness and daily activity. In addition different aspects of quality of life will be evaluated and the consumption of rescue medication will be recorded in patients personal diary.
The treatment period is 3 month with the posibility to continue for an additional 3 month.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers
- •40 years of age or more
- •Osteoarthritis of the hip and or the knee
- •Suffering from pain in the hip and or knee -
排除标准
- •If volunteers are on a waiting list for hip or knee surgery
- •If the volunteers are involved in an other clinical trial
- •If the volunteers are taking other herbal remedies, which canhav influende on # Osteoarthritis.
- •Abusers of alcohol and drugs
- •Volunteers not easy to cope with
结局指标
主要结局
ADL (Activity of daily living)
时间窗: 6 month
Difference in WOMAC ADL on a 100 mm VAS scale (high levels worse)
Pain
时间窗: 6 month
Difference in WOMAC pain on a 100 mm VAS scale (high levels worse)
Rescue medication
时间窗: 6 month
Consumption of rescue medication from diaries (mg)
次要结局
- Stiffness of joints(6 month)
- The volunteer evaluation of Global Disease Severity (PGAD)(6 month)
研究者
Kaj Winther Hansen
professor, MD, DMsCi
University of Copenhagen