12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures on the Improvement of Blood Flow
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Changes of Platelet function assay(PFA)
研究概览
简要总结
This study was conducted to investigate the effects of daily supplementation of Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures on the Improvement of Blood Flow.
详细描述
This study was a 12-week, randomized, double-blind, placebo-controlled human trial. 80 subjects were randomly divided into Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures group and a placebo group. It is to evaluate the changes in the displayed evaluation items when taking Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures once a day, in comparison with taking a placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who meet three or more items
- •Total cholesterol 180~239 mg/dL before a meal
- •LDL cholesterol 130~159 mg/dL before a meal
- •Glucose 100~125 mg/dL before a meal
- •systolic blood pressure(SBP) is 120~140 mmHg
- •Body mass index(BMI) is 23~30 kg/m^2
- •Waist/Hip ratio(WHR) is 0.9 over for man, 0.85 over for a woman
排除标准
- •Participants with marked impairment of platelet function and platelet coagulation
- •Participants who have anticoagulation within 4 weeks before the screening test
- •Participants with a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry system, musculoskeletal system, Inflammation, blood tumor, gastric disease, etc.
- •Participants with BMI(Body mass index) less than 18.5 kg/m^2 or more than 35 kg/m^2 at the screening test
- •Participants who take medicine or healthy functional foods for platelet function, blood circulation improvement, and hyperlipidemia within 4 weeks before the screening test
- •Participants receiving antipsychotic medication within 3 months prior to the screening test
- •Participants suspected of alcoholism(21 unit/week) or substance abuse
- •Participants who have participated in other clinical trials within 3 months prior to the screening test
- •Participants who show the following relevant results in a Laboratory test º Aspartate Transaminase(AST), Alanine Transaminase(ALT) > Reference range 3 times upper limit º Serum Creatinine > 2.0 mg/dl
- •Women who are pregnant or breastfeeding
- •Women who may become pregnant and have not used appropriate contraceptives
- •Participants who the principal investigator judged inappropriate for the participant in this study because of a laboratory test result, etc
结局指标
主要结局
Changes of Platelet function assay(PFA)
时间窗: Baseline, 12 week
The concentration of Platelet function assay(PFA) was assessed before and after the intervention
Changes of blood viscosity
时间窗: Baseline, 12 week
The concentration of blood viscosity was assessed before and after the intervention
次要结局
- Changes of systolic blood pressure(SBP), diastolic blood pressure(DBP), Pulse(screening, 0 week, 6 week, 12 week)
- Changes of indicator of lipid metabolism(Baseline, 12 week)
- Changes of blood coagulation-related indices(Baseline, 12 week)
- Changes of atherosclerosis index(Baseline, 12 week)
研究者
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital