KCT0001733已完成未知
Human study for investigating the effectiveness and safety of Cynanchum wilfordii on control of blood cholesterol
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 84
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
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) Subject who voluntarily agrees to participate and sign in informed consent form
- •2) Adults (20 years = Age, both male and female)
- •3) 18 kg/m2 = BMI (Body Mass Index) = 30 kg/m2
- •4) Fasting blood LDL-cholesterol level = 130 mg/dL
- •5) Fasting blood triglyceride level< 300 mg/dL
排除标准
- •1) Fasting blood LDL-cholesterol level = 190mg/dL
- •2) Subjects who had consistently consumed the drug related to lipid metabolism (ex. statin, diuretics, beta blocker.. etc.) or inflammation metabolism within 4 weeks before the first visit. The subject who have taken thiazide and beta blockers among the diuretics without change of dose during last one year and expected not to change the dosage during the study period.
- •3) Subjects who consumed the functional food or food related to lipid metabolism or inflammation within 4 weeks before the first visit (example: plantsterol, w-3 fatty acid, aloe, chitosan, onion extract. etc.)
- •4) Subjects who are controlling body weight or subjects who have changed of body weight more than 10% within 6 month before the first visit
- •5) Following diseases :
- •- myocardial infarction, stroke
- •- hypertension (Systolic Blood Pressure =140 mmHg OR Diastolic Blood Pressure =100 mmHg)
- •- Diabetes (fasting glucose level = 180 mg/dL)
- •- Liver dysfunction (AST, ALT = 2.5 X upper limit of normal range)
- •- Renal dysfunction (serum creatinine = 1.4 mg/dL)
- •- Chronic inflammatory bowel disease
- •- Autoimmune disease, hyperthyroidism, hypothyroidism or malignant tumor
- •6) Women receiving hormone therapy
- •7) Chronic smoker (= 20 cigarettes / day)
- •8) Subjects with alcoholism or subjects who consume of alcohol more than 140g per week (example: soju about 2.5 bottles/week OR 2.5 glasses/day)
- •9) Excessive exercise (= 10 hours / week)
- •10) Participation in other human study within 4 weeks before the first visit
- •11) Subjects who are sensitive to Cynanchum wilfordii
- •12) Pregnant or lactating women
- •13) Any condition that the principal investigator believes may put the subjects at undue risk
研究者
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