A Multicenter, Pragmatic Randomized, Double-blind, Placebo-controlled Trial of Xuezhikang Capsule for Treating Dyslipidemia: a Postmarketing Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,400
- 主要终点
- Blood samples were drawn were detected,including TC,TG,LDL-C and HDL-C
研究概览
简要总结
Dyslipidemia contributes greatly to the formation and progression of atherosclerosis (AS), which plays a dominant role in leading to CHD.
Xuezhikang is a partially purified extract of fermented red yeast rice (Monascus purpureus). It is composed of 13 kinds of natural statins, unsaturated fatty acids, ergosterol,amino acids, flavonoids, alkaloid, trace element, and so forth. Xuezhikang has been recommended in a guideline for China adult dyslipidemia prevention.
This study aims to evaluate the benefit and side effect of Xuezhikang, a potential alternative drug of statins, for patients with dyslipidemia, and thus provide further evidence for clinical application.
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, Care Provider)
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
- •Age: 18 years to 75 years
- •Patients with Dyslipidemia should be diagnosed according to standard western medicine diagnosis criteria
- •TCM syndrome of patients with dyslipidemia should be diagnosed according to standard TCM syndrome diagnosis criteria
- •Patients who have taken lipid lowering drugs should stop taking for at least two weeks before taking part in this study
- •Patients agree to participate in this study and signed the informed consent form
排除标准
- •Pregnant (positive pregnancy test within 7 days of starting treatment), or lactating women.
- •Patients with Homozygous Familial Hypercholesterolemia
- •Patients with known allergy to Chinese medicine or any other drug
- •Patients with acute myocardial infarction, cerebrovascular accident , severe trauma , major surgery and cancer in half a year.
- •AST or ALT level increases at least twice the upper limits of normal in patients
- •Patients who are taking part in other clinical trials that will influence the results of this study
研究组 & 干预措施
Group A
There are 1614 patients recruited in this group. Patients in this group will take 2 capsules of Xuezhikang every time, twice every day, respectively after breakfast and supper.
干预措施: Xuezhikang capsule (Drug)
结局指标
主要结局
Blood samples were drawn were detected,including TC,TG,LDL-C and HDL-C
时间窗: the detect the change from baseline to the 8th week
次要结局
- Traditional Chinese medicine syndrome scores (TCM-SS) and single TCM symptom(to detect the change at baseline, 2nd week, 4th week, 6th week, and 8th week)
研究者
Xing Liao
Professor
China Academy of Chinese Medical Sciences