KCT0006842已完成未知
The clinical effects of Gyejibongnyeong-hwan (Guizhi Fuling Wan) on patients with hyperlipidemia: a study protocol for a multicenter, double-blind, two-armed parallel, investigator-initiated, exploratory randomized controlled trial
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 90
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
- •(2) Eligible subjects through screening tests and whose lipid profile result after 4 weeks of lifestyle modification correspond to one or more of the following:
- •? Total cholesterol 200 mg /dl or more,
- •? Triglyceride 150 - 499 mg/dL,
- •? LDL-cholesterol 130 - 250 mg/dL,
- •? HDL-cholesterol less than 40 mg/dL
- •(But even if the subject corresponds to more than one, LDL-cholesterol should not exceed 250 mg/dL, and triglyceride should not exceed 499 mg/dL).
- •(3) Those who have voluntarily signed written informed consent after sufficient explanation of this study
排除标准
- •(1) Subjects who have a history of hypersensitivity or allergies to the components of study medication
- •(2) Subjects who have a history of unstable angina, myocardial infarction, atherosclerotic ischemic stroke, transient ischemic attack, cerebrovascular disease, coronary artery disease, coronary artery bypass graft, percutaneous coronary intervention, peripheral arterial disease, carotid artery disease (significant carotid artery stenosis) or abdominal aneurysm; any malignant tumor within five years before screening; drug or alcohol abuse; gastrointestinal surgery or drug absorption disorders due to gastrointestinal disorders.
- •(3) Subject with unstable hypertension (SBP = 180mmHg or DBP = 110mmHg); diabetes (whether taking diabetes medication or fasting blood glucose > 160 mg/dL ); AST or ALT = 2 x UNL; eGFR < 30mL/min or Creatinine = 2 x UNL; Creatine kinase (CK) > 2 x UNL or a history of myopathy or rhabdomyolysis; thyroidal disease; pancreatitis
- •(4) Subjects who have administered a concomitant drug during the clinical trial period or who are judged to be unavoidable to administer a concomitant drug
- •(5) Subjects who use drugs and food that can affect lipid profile within 4 weeks prior to the screening (statins, fibrates, bile acid sequestrants, niacin, anti-obesity drugs, steroids for systemic action, fish oil, omega-3, cholestin products, fiber-based laxatives, phytosterol margarine, etc.)
- •(6) Subjects who have participated in other clinical trials within the last 3 months
- •(7) Female subjects who are pregnant or lactating
- •(8) Female subjects who plan to conceive
- •(9) Subjects who the investigator considers to be inappropriate to participate in this trial.
研究者
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