NCT05349253已完成不适用
Effect of Garlic Extracts on Changes in Cerebral Blood Flow: Randomized, Double-blind, Placebo-controlled Study
适应症
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 Cerebral blood flow
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 cerebral blood flow.
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 Cerebral blood flow
时间窗: Change of Cerebral blood flow before and after 60 minutes garlic extract intake basis in the experimental group
Regional cerebral blood flow is checked using Single Photon Emission Computed Tomography(SPECT)
次要结局
未报告次要终点
研究者
Yong-il Shin
Professor
Pusan National University Yangsan Hospital
研究点 (2)
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