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

  • STATUS
    Recruiting
  • participants needed
    80
  • sponsor
    Chonbuk National University Hospital
Updated on 19 February 2024

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.

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 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.

Details
Condition Blood Flow
Age 19years - 80years
Treatment Placebo, Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures
Clinical Study IdentifierNCT04389125
SponsorChonbuk National University Hospital
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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 Aspartate Transaminase(AST), Alanine Transaminase(ALT) > Reference range 3 times upper limit 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
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