NCT02269046Unknown不适用
A Multi-center, Randomized, Stratified, Active-controlled Trial to Evaluate the Effects of Acupuncture and Moxibustion for Hyperlipidemias
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine3 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2014年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 210
- 试验地点
- 3
- 主要终点
- low-density lipoprotein cholesterol (LDL-C)
研究概览
简要总结
The purpose of this study is to evaluate the effect of 12 weeks of acupuncture and moxibustion compared with active control, on absolute and percent change from baseline in low-density lipoprotein cholesterol (LDL-C) among those with hyperlipidemia.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject signed the informed consent
- •Male or female ≥18 to ≤75 years of age
- •Fasting TG ≤400 mg/dL
- •Fasting LDL-C as determined by central laboratory on admission and meeting the following LDL-C values based on risk factor status:
- •0-1 Risk Factor Group: LDL-C ≥160 mg/dL
- •2+ Risk Factor Group: LDL-C ≥130 mg/dL
- •CHD or CHD risk equivalents: LDL-C ≥100 mg/dL
- •Major Risk factors: （1）Cigarette smoking;（2）Hypertension (BP ≥140/90 mmHg or on anti-hypertensive medication);（3）Low HDL cholesterol (HDL-C <40 mg/dL);（4）Family history of premature CHD (CHD in male first degree relative <55 years; CHD in female first degree relative <65 years);（5）Age (men ≥45 years; women ≥55 years)
- •CHD and CHD equivalents:（1）Other clinical forms of atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease);（2）Diabetes;（3）Multiple risk factors that confer a 10-year risk for CHD >20%
排除标准
- •CHD or CHD risk equivalent and not receiving statin therapy, with LDL-C at screening ≤99 mg/dL
- •NYHA II, III or IV heart failure, or last known left ventricular ejection fraction <30%
- •Uncontrolled cardiac arrhythmia, atrial fibrillation with rapid ventricular response, or not controlled supraventricular tachycardia in the past 3 months prior to randomization
- •Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
- •Planned cardiac surgery or revascularization
- •Type 1 diabetes or newly diagnosed type 2 diabetes or poorly controlled type 2 diabetes
- •Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) >160 mmHg or diastolic BP (DBP) >100 mmHg
- •Subjects taken red yeast rice, niacin >200 mg/d, or omega-3 fatty acids >1000 mg/d or prescription lipid-regulating drugs other than statins or ezetimibe, such as fibrates and derivatives, or bile-acid sequestering resins in the last 6 weeks prior to LDL-C screening
- •Subjects taken systemic cyclosporine, systemic steroids, vitamin A derivatives and retinol derivatives for the treatment of dermatologic conditions in the last 3 months prior to LDL-C screening
- •Hyperthyroidism or hypothyroidism
- •Moderate to severe renal dysfunction
- •Active liver disease or hepatic dysfunction
- •CK >3 times the ULN at screening or at end of lipid stabilization period, confirmed by a repeat measurement at least 1 week apart
- •Known active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction in the judgment of the investigator
- •Deep vein thrombosis or pulmonary embolism within 3 months prior to randomization
- •Current therapeutic anticoagulation with vitamin K antagonist, heparin, low-molecular weight heparin, direct thrombin inhibitor
- •Currently enrolled in another investigational device or drug study
- •Female subject during pregnant or breast feeding period
- •History of malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma)
- •Known sensitivity to any of the products to be administered during dosing
- •Subjects couldn't provide the written informed consent and/or comply with all required study procedures
研究组 & 干预措施
Acupuncture and moxibustion
Experimental
- therapeutic lifestyle change
- Group I:Juque (RN14), Tianshu (ST25, bilateral), Fenglong (ST40, bilateral), Zusanli (ST 36, bilateral), Sanyinjiao (SP6, bilateral)
- Group II: Pishu (BL20, bilateral), Xinshu (BL15, bilateral), Ganshu (BL18, bilateral), Shenshu (BL23, bilateral)
- Group I and II will change alternatively every other week .
- Once per day five days per week.
干预措施: acupuncture and moxibustion (Other)
Acupuncture and moxibustion
Experimental
- therapeutic lifestyle change
- Group I:Juque (RN14), Tianshu (ST25, bilateral), Fenglong (ST40, bilateral), Zusanli (ST 36, bilateral), Sanyinjiao (SP6, bilateral)
- Group II: Pishu (BL20, bilateral), Xinshu (BL15, bilateral), Ganshu (BL18, bilateral), Shenshu (BL23, bilateral)
- Group I and II will change alternatively every other week .
- Once per day five days per week.
干预措施: Therapeutic Lifestyle Change (Other)
Simvastatin
Active Comparator
- therapeutic lifestyle change
- simvastatin
- oral administration with 10mg per day
- seven days per week for 12 weeks.
干预措施: Simvastatin (Drug)
Simvastatin
Active Comparator
- therapeutic lifestyle change
- simvastatin
- oral administration with 10mg per day
- seven days per week for 12 weeks.
干预措施: Therapeutic Lifestyle Change (Other)
waiting list
Other
- therapeutic lifestyle change
干预措施: Therapeutic Lifestyle Change (Other)
结局指标
主要结局
low-density lipoprotein cholesterol (LDL-C)
时间窗: 12 weeks
To evaluate the effect of 12 weeks of acupuncture compared with active control, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) among those with hyperlipidemia.
次要结局
- high-density lipoprotein cholesterol (HDL-C)(12 weeks)
- total cholesterol (TC)(12 weeks)
- triglyceride(TG)(12 weeks)
- the rate of subjects achieving LDL-C goal(12 weeks)
研究者
研究点 (3)
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