KCT0003434已完成未知
A Randomized, Double-blind, Placebo-controlled Intervention Study to evaluate the Efficacy and Safety of Barley Sprout” Extraction BS-1 in Healthy Volunteer with high cholesterol
Kyung Hee University Hospital0 个研究点目标入组 78 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
- 78
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 79?(Year)（—）
- 性别
- All
入选标准
- •1) Men and women aged 20 to under 79
- •2) 200 mg/dl = Total cholesterol= 239 mg/dl
- •3) 130 mg/dl = LDL cholesterol = 159 mg/dl
- •4) Subjects who agree to participate in this study and have given their written informed consent
排除标准
- •1) Currently taking drugs for the control of hyperlipidemia or the improvement of blood circulation
- •2) HDL cholesterol = 40mg/dl
- •3) 200 mg/dl = TG(Triglyceride)
- •4) Subjects who experienced adverse reactions such as allergies when taking sprouts barley products
- •5) Subjects who have a history of renal failure, liver disease (hepatitis, liver cirrhosis, liver cancer), psychiatric disorders such as dementia, major depression, generalized anxiety disorder
- •6) History or presence of clinically significant medical condition such as stroke, heart disease (heart failure, angina, myocardial infarction), malignant disease, narrow angle glaucoma, resistant hypertension, lung disease, systolic blood pressure greater than 180 mmHg in hypertension
- •7) Subjects who have clinical manifestation associated renal or hepatic disorders (serum creatinine > 2.0 mg/dL, liver function test: ALT, AST > 2.5 times of the upper limit of normal range)
- •8)Subjects who show the following results;
- •- Fasting blood glucose 160 mg/dL, despite of taking oral antidiabetic agents
- •- Platelet 150,000/mm3, WBC 3,000/mm3, Hemoglobin 9.5 g/dL for men or 9.0 g/dL for women
- •9) History or presence of any clinically significant medical condition such as hypertension, diabetes or smokers, (When two or more are applicable)
- •10) Use of the medications or products such as oral steroid, hormones within 12 weeks prior to the scheduled study drug administration. Subjects who have been taking medication or functional food, known to interfere with the absorption, metabolism and elimination of study drug (test food) or Subjects who participated in any other clinical trial within 3 months prior to the scheduled study drug administration
- •11) Subjects who have undergone surgical procedures within 6 months prior to the scheduled study drug administration or who have are taking medications (treatment for acupuncture or blood circulation improvement or health food,drug that may cause abuse) within 1 months prior to the scheduled study drug administration
- •12) Pregnant and lactating women
- •13) Subjects who do not follow informed-consent rules, or who are judged by the investigator to be inappropriate for inclusion in the study
研究者
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