Comparing Different Preparations and Dosages of Rosehip Powder in Patients With Painful Osteoarthritis of the Knee: An Exploratory Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Pain, Walking on flat surface - range: 0-100
研究概览
简要总结
The aim of this study is to compare three combinations of preparations in a comparative trial program on rosehip powder for knee OA. The trial is a comparative, 12-week, randomized, double-blind, active-controlled trial, designed to determine the comparative efficacy and safety of these preparations in patients with pain from knee OA.
详细描述
Complementary or alternative therapies (incl. nutraceuticals - functional ingredients sold as powders, pills, and other medicinal forms not generally associated with food) for OA are commonly used, and it is therefore important that health care providers are aware of the evidence supporting the claims. One proposed nutraceutical which has shown promising results in OA patients, is the hip powder of Rosa canina.
The findings from a previous meta-analysis of rosehip powder from Rosa canina for symptomatic treatment of OA was a small but potentially relevant reduction of pain and a statistically significant reduction in use of analgesics.
The present study is undertaken to compare two different products, one of which is tested in two different doses, in a non-inferiority design.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 years of age and have clinical evidence (diagnosed according to the American College of Rheumatology [ACR] criteria) and radiographic evidence of OA.
- •Eligible patients have a self-reported pain level corresponding to at least 40 mm on a 100 mm VAS when screened
排除标准
- •Patients will not be considered eligible if they are considered morbidly obese -having a body mass index (BMI) above 40 kg/m2, concurrent medical or arthritic conditions that could confound evaluation of the index joint, or coexisting disease that could preclude successful completion of the trial.
- •Patients who already take a rosehip powder as a dietary supplement; have inability to speak Danish fluently; or have a mental state impeding compliance with the program will not be considered eligible for inclusion.
结局指标
主要结局
Pain, Walking on flat surface - range: 0-100
时间窗: week 12
Knee injury and Osteoarthritis Outcome Score (KOOS) subscale item
次要结局
- Pain - range: 0-100(week 12)
- Symptoms - range: 0-100(week 12)
- VAS Disability - 0-100(week 12)
- VAS patient global assessment of disease status - 0-100(week 12)
- VAS physician global assessment of disease status - 0-100(week 12)
- Physical component summary - range: 0-100(week 12)
- Mental component summary - range: 0-100(week 12)
- Function in daily living - range: 0-100(week 12)
- Knee related Quality of life - range: 0-100(week 12)
- VAS Pain - 0-100(week 12)
研究者
Henning Bliddal
Professor
Frederiksberg University Hospital