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

Chonbuk National University

Status: Unknown

Conditions: Blood Flow

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures

Study type: Interventional

Funder types: Other

Identifiers

NCT04389125

HJ-BF-AAM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Improvement of Blood Flow group

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures

Placebo group

Placebo Comparator group

Description:

One packet once a day, after breakfast (1.5 g/day)

Treatment:

Dietary Supplement: Placebo