NCT00669123已完成4 期
Fase IV Clinical Trial to Evaluate Chondroitin Sulphate Efficacy and Safety in Patients With Knee Osteoarthritis and Psoriasis
Bioiberica2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2008年4月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Huskisson Visual Analogue Scale
研究概览
简要总结
The purpouse of this study is to determine the efficacy and safety of chondroitin sulphate conventional treatment in patients with both knee osteoarthritis and plaque psoriasis.
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, 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
- •Primary knee OA according to ACR criteria;
- •OA of radiological stages 1 to 3 according to Kellgren-Lawrence;
- •VAS of pain ≥30;
- •PASI ≥ 5.
排除标准
- •Known allergy to chondroitin sulphate;
- •Other bone and articular diseases such as chondrocalcinosis, Paget's disease, rheumatoid arthritis, psoriatic arthritis, acromegaly, hemochromatosis, Wilson's disease;
- •Patients with skin conditions that could interfere in the clinical trial evaluation
研究组 & 干预措施
2
Placebo Comparator
干预措施: Placebo (Drug)
1
Experimental
Chondroitin sulphate
干预措施: Chondroitin sulphate (Drug)
结局指标
主要结局
Huskisson Visual Analogue Scale
时间窗: Monthly
Psoriasis Area and Severity Index
时间窗: Monthly
次要结局
- Lequesne Index(Monthly)
- Use of rescue medication(Monthly)
- SF-36 Health Questionaire(3 months)
- Overall Lession Severity Scale(Monthly)
- Physician's Global Assessment of improvement(Monthly)
- Histological assessment of skin biopsies(3 months)
- Dermatology Life Quality Index(Monthly)
- Tolerability(Monthly)
- Adverse events(Monthly)
研究者
研究点 (2)
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