Status:
UNKNOWN
Efficacy and Safety of Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures on the Improvement of Blood Flow
Lead Sponsor:
Chonbuk National University Hospital
Conditions:
Blood Flow
Eligibility:
All Genders
19-80 years
Phase:
NA
Brief Summary
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
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 g...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04389125
Start Date
January 30 2020
End Date
May 30 2021
Last Update
May 15 2020
Active Locations (1)
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1
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea, 54907