The Efficacy and Safety of Curcuma Domestica Extracts and Ibuprofen for Therapy of Patients With Knee Osteoarthritis, the Randomized Double-blinded Controlled Trial, Multicenter Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 367
- 试验地点
- 6
- 主要终点
- Change in mean WOMAC pain subscale
研究概览
简要总结
Osteoarthritis of knee is common degenerative musculoskeletal diseases. Non-steroidal antiinflammatory drugs (NSAIDs) are used to decrease pain symptom but someone can not tolerate its gastrointestinal adverse effects. In vitro studies showed that curcumin had an inhibitory effect on substances playing an important role in inflammatory pathway. The mechanisms by which curcumin prevents inflammation are postulated through inhibition of many cytokines, for example, lipo-oxygenase, cyclo-oxygenase, and phospholipase. Therefore, if curcumin is effective as NSAIDs with less side effects, it can be an alternative treatment for those OA knee patients.
详细描述
Curcumin was demonstrated to be safe and had anti-inflammatory activity in six studies in humans. It may exert its anti-inflammatory activity by inhibition of a number of different molecules that play a role in inflammation.
Our experience in a study of 100 subjects revealed a trend towards a greater effect in OA patients receiving Curcuma domestica extracts. However, studies with adequate sample and dosage of Ibuprofen are recommended to demonstrate the efficacy of C.domestica extracts in alleviating knee pain and improving knee functions.
The objective of the study was to determine the efficacy and safety of C.domestica extracts in pain reduction and functional improvement in patients with knee osteoarthritis.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary osteoarthritis
- •Knee pain score more than or equal to 5 point (NRS 0-10)
- •Age >= 50 years, not > 75 years
- •Knee crepitus
- •Knee stiffness less than 30 minutes
- •Urine pregnancy test negative in case of not being menopausal period
排除标准
- •History of GI ulcer or melena
- •Having hepatic or bile duct diseases(SGOT ≥ 37 u/L, SGPT ≥ 40 u/L)
- •Having renal disease or abnormal renal functions (serum creatinine ≥ 1.5 mg/dl)
- •Asthma or gout
- •Allergy to ibuprofen or curcumin
- •History of intraarticular knee injection within 6 months
- •Post knee arthroplasty
- •History of intermittent claudication
- •Unable to walk, for example hemiplegia, severe lung/heart diseases
- •Knee x-ray found chondrocalcinosis
- •On anticoagulant
研究组 & 干预措施
curcuma domestica
1,500 mg/day (oral) divided into 3 times for 28 days
干预措施: Curcuma domestica extracts (Drug)
Ibuprofen
1,200 mg/day (oral) divided into 3 times for 28 days
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Change in mean WOMAC pain subscale
时间窗: 12 months
次要结局
- Adverse events(12 months)
- Quality of life: SF-36(12 months)
- Change in WOMAC score(12 months)
研究者
Vilai Kuptniratsaikul
Associate Professor
Mahidol University