Effect of Garlic Extracts on Changes in Blood Flow Velocity in the Carotid Artery: Randomized, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change of peak systolic blood flow velocity in the internal carotid arteries
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of Garlic extracts for improving of blood flow velocity in the carotid artery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults 19 years of age or older as of the screening date
- •Those with no history of treatment for hypertension within the last 3 months
- •A person who voluntarily decides to participate and agrees in writing to abide by the precautions after hearing and fully understanding the detailed explanation of this study
排除标准
- •Those with systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher
- •Those who have had a stroke, myocardial infarction, percutaneous coronary angioplasty or surgery for coronary angioplasty within the past 6 months
- •Persons with acute and severe cardiovascular diseases such as heart failure, myocardial infarction, and stroke
- •Those with acute/chronic inflammation such as cancer, rheumatic disease, autoimmune disease, gastrointestinal disease, etc.
- •Those who have a history of gastrointestinal diseases (eg Crohn's disease) or gastrointestinal surgery (except simple appendicectomy or hernia surgery) that may affect the absorption of the product for human application testing
- •Persons who have taken prohibited concomitant drugs within the last 3 months
- •Persons with a history of clinically significant hypersensitivity reactions to drugs and health functional foods
- •Those who have received antipsychotic drug treatment within 2 months before the screening test
- •Persons with a history of drug or alcohol abuse
- •Pregnant or lactating women
- •When women of childbearing potential of childbearing potential do not accept the implementation of appropriate contraceptive methods (except for women who have undergone sterilization)
- •Subjects who have participated in health functional food related research or clinical trials within the last 3 months
- •In case the principal investigator judges that it is not appropriate to participate in this study
结局指标
主要结局
Change of peak systolic blood flow velocity in the internal carotid arteries
时间窗: Change of peak systolic blood flow velocity before and after 60 minutes garlic extract intake basis in the experimental group
Doppler ultrasonography is used for measurement.
Change of peak systolic blood flow velocity in the common carotid arteries
时间窗: Change of peak systolic blood flow velocity before and after 60 minutes garlic extract intake basis in the experimental group
Doppler ultrasonography is used for measurement.
Change of end-diastolic blood flow velocity in the internal carotid arteries
时间窗: Change of end-diastolic blood flow velocity before and after 60 minutes garlic extract intake basis in the experimental group
Doppler ultrasonography is used for measurement.
Change of end-diastolic blood flow velocity in the common carotid arteries
时间窗: Change of end-diastolic blood flow velocity before and after 60 minutes garlic extract intake basis in the experimental group
Doppler ultrasonography is used for measurement.
Change of diastolic and systolic blood pressure
时间窗: Change of diastolic and systolic blood pressure before and after 60 minutes garlic extract intake basis in the experimental group
The blood pressure device is measured by IntelliVue MP50® from Philips. When measuring blood pressure, the study subjects should sit comfortably for at least 5 minutes and then take the measurements. The unit is mmHg and is expressed as an integer.
次要结局
未报告次要终点
研究者
Yong-il Shin
Professor
Pusan National University Yangsan Hospital