Evolution of Pain at Three Months by Oral Resveratrol in Primary Knee Osteoarthritis: a Multicenter, Double-blind, Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 5
- 主要终点
- Mean change from baseline in knee pain in the previous 48 hours
研究概览
简要总结
The purpose of this study is to determine whether resveratrol is effective in the treatment of painful knee osteoarthritis.
详细描述
Osteoarthritis (OA) is the first cause of handicap in individuals over 40 years-old in France. OA physiopathology is driven in part by local joint inflammation responsible for pain and joint destruction. Experimental studies have shown that resveratrol, a molecule antagonist to the aryl hydrocarbon receptor, has anti-inflammatory and chondroprotective properties in vitro and in vivo. The investigators hypothesize that oral resveratrol, in a new formulation improving its bioavailability, could reduce knee pain at 3 months as compared with placebo in people with knee OA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Age ≥ 40 years-old
- •Knee osteoarthritis fulfilling 1986 American College of Rheumatology (ACR) criteria
- •Pain on numeric rating scale ≥ 40/100
- •Symptom duration ≥ 1 month
- •Kellgren and Lawrence X-Ray score 1, 2 or 3
- •Written consent obtained
- •Health insurance cover
排除标准
- •History of symptomatic crystal or inflammatory arthritis
- •Knee surgery ≤ 1 year
- •Knee trauma ≤ 2 months
- •Knee intra-articular injections of corticosteroids and/or hyaluronic acid ≤ 2 months
- •Neurologic disorders involving the lower limbs
- •Patient not understanding and not speaking french
- •Participation in another biomedical research
- •Contraindication to resveratrol or hypersensitivity to any of its constituents
- •Current use of intramuscular, intravenous or oral corticosteroids
- •Uncontrolled diseases that may require intramuscular, intravenous or oral corticosteroids
- •Current use of anticoagulants
研究组 & 干预措施
Oral resveratrol
Resveratrol will be administered orally, at the dose of 40 mg (2 caplets) twice a day for one week, then at the dose of 20 mg (1 caplet) twice a day, for a total duration of 6 months.
干预措施: oral resveratrol (Drug)
Oral Placebo
Placebo will be administered orally : 2 caplets twice a day for one week, then 1 caplet twice a day, for a total duration of 6 months.
干预措施: oral placebo (Drug)
结局指标
主要结局
Mean change from baseline in knee pain in the previous 48 hours
时间窗: at 3 months
Using a self-administered 11-point pain numeric rating scale, with 0 = no pain and 100 = maximal pain
次要结局
- Mean change from baseline in specific activity limitation(at 6 months)
- Mean change from baseline in knee pain in the previous 48 hours(at 6 months)
- Proportion of OARSI-OMERACT responders(at 6 months)
- Number of intra-articular injections of corticosteroids or hyaluronic acid since last contact(at 6 months)
- Self-reported consumption of non-steroidal anti-inflammatory drugs since last contact(at 6 months)
- Mean change from baseline in patient's global assessment(at 6 months)
- Self-reported consumption of analgesics (non-opioid, weak and strong opioids) since last contact(at 6 months)
- Proportion of OARSI-OMERACT responders(at 3 months)
- Mean change from baseline in specific activity limitation(at 3 months)
- Mean change from baseline in patient's global assessment(at 3 months)
- Number of intra-articular injections of corticosteroids or hyaluronic acid since last contact(at 3 months)
- Self-reported consumption of analgesics (non-opioid, weak and strong opioids) since last contact(at 3 months)
- Self-reported consumption of non-steroidal anti-inflammatory drugs since last contact(at 3 months)