KCT0004564已完成未知
Efficacy of Hwangryunhaedok-tang for patients with hyperlipidemia: a randomized, double-blind, placebo-controlled, parallel, investigator-initiated clinical trial
Dunsan Korean Medicine Hospital of Daejeon University0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •(1) adults aged 19 years or over but under 65 years at the screening visit
- •(2) 130 mg/dl = baseline LDL cholesterol levels = 250 mg/dl
- •(3) those who have voluntarily signed written informed consent approved by institutional review board, after sufficient explanation of this study
排除标准
- •(1) having a history of unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass surgery, coronary intervention or abdominal aneurysm within 3 months prior to screening
- •(2) use of statins, ezetimibe, fibric acid derivatives, proprotein convertase subtilisin/kexin type 9 inhibitors, cholestyramine, nicotinic acid, omega-3 fatty acids, systemic steroids, diuretics, amiodarone, cyclosporin that can affect lipid profile within 4 weeks prior to screening (However, use of omega-3 fatty acids 4 g or less per day and short-term use of 6 mg or less per day of dexamethasone or equivalent corticosteroids within 5 days, which would not affect lipid levels, are allowed.)
- •(3) uncontrolled hypertension with systolic blood pressure of more than 180 mmHg or diastolic blood pressure of more than 110 mmHg
- •(4) uncontrolled diabetes mellitus with HbA1c of more than 9% or fasting blood glucose of more than 160 mg/dl
- •(5) uncontrolled thyroid function (thyroid stimulating hormone (TSH) levels = 1.5 times upper limit of normal)
- •(6) triglyceride levels of more than 500 mg/dl
- •(7) severe liver or renal disease (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels = 3 times upper limit of normal or creatinine levels = 2 times upper limit of normal)
- •(8) participants with a history of alcohol abuse or drug abuse within the past year
- •(9) women who are pregnant or lactating, or women who do not agree to use effective methods of contraception during the clinical trial
- •(10) participants with genetic problems, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •(11) participants with known hypersensitivity to investigational products
- •(12) participants who had taken other investigational products within 3 months
- •(13) participants who are thought to be inappropriate for this study
研究者
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