Efficacy and Safety of Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures on the Improvement of Blood Flow

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Blood Flow

Intervention / Treatment
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* Dietary Supplement: Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who meet three or more items Smoker 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Improvement of Blood Flow group<br>One packet once a day, after breakfast (1.5 g/day, 1.5 g/day as an Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures) | Dietary Supplement: Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures<br>* One packet once a day, after breakfast, for 12 week<br>|
| Placebo Comparator: Placebo group<br>One packet once a day, after breakfast (1.5 g/day) | Dietary Supplement: Placebo<br>* Placebo for 12 week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Platelet function assay(PFA) | The concentration of Platelet function assay(PFA) was assessed before and after the intervention | Baseline, 12 week | 
| Changes of blood viscosity | The concentration of blood viscosity was assessed before and after the intervention | Baseline, 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of systolic blood pressure(SBP), diastolic blood pressure(DBP), Pulse | systolic blood pressure(SBP), diastolic blood pressure(DBP), Pulse were measured in study screening, visit 1(0 week), visit 2(6 weeks) and visit 3(12 weeks). | screening, 0 week, 6 week, 12 week | 
| Changes of blood coagulation-related indices | Blood coagulation-related indices(e.g. Plasminogen activator inhibitor-1, Serotonin, Thromboxane B2, activated partial thromboplastin time) were measured in study visit 1(0 week) and visit 3(12 weeks). | Baseline, 12 week | 
| Changes of indicator of lipid metabolism | Lipid metabolism(e.g. Total cholesterol, Triglyceride, Low Density Lipoprotein-cholesterol, High Density Lipoprotein-cholesterol, Non High Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 weeks). | Baseline, 12 week | 
| Changes of atherosclerosis index | Atherosclerosis index(e.g. Total cholesterol/High Density Lipoprotein-cholesterol, Low Density Lipoprotein-cholesterol/High Density Lipoprotein-cholesterol, Triglyceride/High Density Lipoprotein-cholesterol, (Total cholesterol-High Density Lipoprotein-cholesterol)/High Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 weeks). | Baseline, 12 week |