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【ChiCTR1800014883】紅麴治療高血脂症的隨機對照研究

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基本信息

登记号

ChiCTR1800014883

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2018-02-12

临床申请受理号

靶点

适应症

血脂异常

试验通俗题目

紅麴治療高血脂症的隨機對照研究

试验专业题目

紅麴治療高血脂症的隨機對照研究

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

110

联系人通讯地址

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临床试验信息

试验目的

Red yeast rice (RYR) has been used as an alternative treatment for hyperlipidemia recently. According to the previous study, other compounds, besides monacolin k in RYR, may also have efficacy on serum lipid improvement. This study aims at examining the efficacy of monacolin k-rich and Gamma-Aminobutyric Acid (GABA)-rich red yeast rice (Monascus pilosus) regarding treating hyperlipidemia on a randomized control, double-blind clinical trial.

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

Randomization was done by a trial administrator who was not involved in the clinical intervention or evaluation using computer-generated random sequence after participants enrolled in this study before administrating medications.The random sequences evenly distributed all participants to three study arms.

盲法

All doctors, pharmacists, project managers, statisticians and participants in this research were blinded to the allocation sequence throughout the entire trial phase.

试验项目经费来源

Grand of Chang Gung University Center for Industry Sponsored Research and Collaborations SCRPD1A0011

试验范围

目标入组人数

实际入组人数

第一例入组时间

2011-04-01

试验终止时间

2013-10-31

是否属于一致性

入选标准

Before the exclusion were interviewed by internal medicinal physicians at Chang-Gung Memorial hospital in a preliminary screening, subjects met the criteria (LDL >100 mg/dl, TC > 200 mg/dl)　will be included.；

排除标准

Some subjects were excluded from the study due to the following factors: 1) take hormone replacement therapy or immunosuppressive agents, 2) take the lipid-regulating drugs, 3) take the drugs known to affect lipid concentrations, 4) take the drugs known to be associated with rhabdomyolysis, cardiovascular disease, severe systemic and chronic disease, malignant neoplasm, 5) pregnancy, 6) receive insulin or oral hypoglycemic agents 7) have an endocrine disease related to lipid abnormalities.；

研究者信息

研究负责人姓名

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试验机构

development department, Gunze Limited, Japan

研究负责人电话

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研究负责人邮箱

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研究负责人邮编

110

联系人通讯地址