Clinical Efficacy of Glucosamine Plus Diacerein Versus Mono-therapy of Glucosamine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- pain visual analog scores
研究概览
简要总结
The purpose of this study is to compare pain scores, WOMAC total and subscores, actual and change of joint space width and the rate of gastrointestinal side effects at 4, 8, 12, and 24 weeks between dual-therapy of diacerein and glucosamine versus a mono-therapy of glucosamine in OA patients
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of primary osteoarthritis
- •Mild deformity Clinical (having no varus or valgus deformity, no crepitus) ? Physical examination grade 0 assessed by stress test Radiographic assessment (Kellgrane-lawrance type II-III), a minimum baseline medial tibiofemoral JSW of _2 mm.
- •Willing to participate and provide written informed consent
排除标准
- •Non-secondary osteoarthritis Rheumatoid arthritis, inflammatory arthritis (e.g. SLE, Gout), post traumatic osteoarthritis, those who received intra-articular treatment of the signal joint with any product (corticosteroids in the previous 2 months, or glycosaminoglycans/hyaluronic acid in the previous 6 months) or had undergone joint lavage andarthroscopic procedures in the previous 6 months.
- •No contraindication of using diacerein and glucosamine
- •Non-current or ex-users of oral SYSADOA (e.g., glucosamine sulphate, chondroitin sulphate, diacerein, piascledine), anti-depressants, tranquillisers, antacids or antibiotics known hypersensitivity to diacerein, to similar compounds, to the excipients or to paracetamol
研究组 & 干预措施
Glucosamine sulfate & Diacerein
Glucosamine sulfate (sachet) 1500 mg and Diacerein 50 mg tablet by mouth once daily for 24 weeks
干预措施: Glucosamine sulfate (Drug)
Glucosamine sulfate & Diacerein
Glucosamine sulfate (sachet) 1500 mg and Diacerein 50 mg tablet by mouth once daily for 24 weeks
干预措施: Diacerein (Drug)
Glucosamine sulfate & Placebo
Glucosamine sulfate 1500 mg and Placebo (for Diacerein) 50 mg by mouth once daily for 24 weeks
干预措施: Glucosamine sulfate (Drug)
Glucosamine sulfate & Placebo
Glucosamine sulfate 1500 mg and Placebo (for Diacerein) 50 mg by mouth once daily for 24 weeks
干预措施: Placebo (for Diacerein) (Drug)
结局指标
主要结局
pain visual analog scores
时间窗: 24 weeks
次要结局
- Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scores(24 weeks)
- actual and change of joint space width(24 weeks)
- Rate of gastrointestinal side effects(24 weeks)
研究者
Jatupon Kongtharvonskul
Section for Clinical Epidemiology and Biostatistics, Faculty of Medicine Ramathibodi Hospital, Bangkok, Thailand
Ramathibodi Hospital