The Effect of Puerarin Tablets in Treating Metabolism Syndrome in Patients With Chronic Rheumatic Diseases
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change from baseline in homeostasis model assessment (HOMA-IR)
研究概览
简要总结
To evaluate the Effect of Puerarin tablets versus statins in treating metabolism syndrome in patients with chronic rheumatic diseases
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
- 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 with rheumatic disease
- •patients with metabolic Syndrome
- •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
puerarin tablet 50 mg
Patients were orally administrated with 50 mg puerarin tablet three times a day for 24 weeks. Furthermore, patients receive stable treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, bone metabolism regulators and gastric mucosal protective agents on as-needed basis.
干预措施: puerarin tablet 50 mg (Drug)
Atorvastatin tablet 20 mg
Patients were orally administrated with 20 mg Atorvastatin tablet once a day for 24 weeks. Furthermore, patients receive stable treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, bone metabolism regulators and gastric mucosal protective agents on as-needed basis.
干预措施: Atorvastatin tablet 20 mg (Drug)
结局指标
主要结局
Change from baseline in homeostasis model assessment (HOMA-IR)
时间窗: At 0 week, 12 weeks, 24 weeks and 48 weeks
次要结局
- interleukin-1 (IL-1)(at 0 week, 12 weeks, 24 weeks, 48 weeks)
- Fasting serum low-density lipoprotein cholesterol (LDL-C)(at 0 week, 12 weeks, 24 weeks, 48 weeks)
- Fasting serum high-density lipoprotein cholesterol (HDL-C)(at 0 week, 12 weeks, 24 weeks, 48 weeks)
- erythrocyte sedimentation rate (ESR)(at 0 week, 12 weeks, 24 weeks, 48 weeks)
- C reactive protein (CRP)(at 0 week, 12 weeks, 24 weeks, 48 weeks)
- Fasting serum total cholesterol (TC)(at 0 week, 12 weeks, 24 weeks, 48 weeks)
- Fasting serum triglycerides (TGs)(at 0 week, 12 weeks, 24 weeks, 48 weeks)
- tumor necrosis factor (TNFα)(at 0 week, 12 weeks, 24 weeks, 48 weeks)
- interleukin-8 (IL-8)(at 0 week, 12 weeks, 24 weeks, 48 weeks)
- interleukin-6 (IL-6)(at 0 week, 12 weeks, 24 weeks, 48 weeks)
- Fasting serum insulin(at 0 week, 12 weeks, 24 weeks, 48 weeks)
- Fasting serum glucose(at 0 week, 12 weeks, 24 weeks, 48 weeks)
- Kidney function(at 0 week, 12 weeks, 24 weeks, 48 weeks)
- Liver function(at 0 week, 12 weeks, 24 weeks, 48 weeks)
- blood cell count(at 0 week, 12 weeks, 24 weeks, 48 weeks)
研究者
Yang Min
Ph.D
Chengdu PLA General Hospital