NCT02257047Unknown不适用
Red Yeast Rice and Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis
Chengdu PLA General Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes from baseline in Carotid intima-media thickness at 24 weeks
研究概览
简要总结
To evaluate the effect of red yeast rice on subclinical atherosclerosis in patients with rheumatoid arthritis
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with a definite diagnose of rheumatoid arthritis(RA) were included if they met the classification criteria for RA established by the American Rheumatism Association (ACR) and European League Against Rheumatism (EULAR) in 2010
- •aged from 18 to 75 years
- •without conflict to the written, informed consent signed prior to the enrollment
- •no severe hepatic or renal disorders
- •no known carotid artery stenosis
- •no coagulation disorders
- •no hypertension
排除标准
- •being in pregnancy, lactation period or under a pregnancy plan
- •being allergic to the test drug
- •not compatible for the trial medication
- •without full legal capacity
研究组 & 干预措施
RYR
Experimental
Patients under the treatment of red yeast rice
干预措施: RYR (Dietary Supplement)
Control
Sham Comparator
Patients under the treatment of tea
干预措施: Tea (Dietary Supplement)
结局指标
主要结局
Changes from baseline in Carotid intima-media thickness at 24 weeks
时间窗: At 0 week, 12 weeks, 24 weeks
次要结局
未报告次要终点
研究者
Yang Min
Ph.D
Chengdu PLA General Hospital
研究点 (1)
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