Efficacy and Safety of Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures on the Improvement of Blood Flow
NCT ID: NCT04389125
Last Updated: 2020-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2020-01-30
2021-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Improvement of Blood Flow group
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)
Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures
One packet once a day, after breakfast, for 12 week
Placebo group
One packet once a day, after breakfast (1.5 g/day)
Placebo
Placebo for 12 week
Interventions
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Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures
One packet once a day, after breakfast, for 12 week
Placebo
Placebo for 12 week
Eligibility Criteria
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Inclusion Criteria
* 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 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
19 Years
80 Years
ALL
Yes
Sponsors
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Chonbuk National University Hospital
OTHER
Responsible Party
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Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Locations
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Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HJ-BF-AAM
Identifier Type: -
Identifier Source: org_study_id
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