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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-30

Study Completion Date

2021-05-30

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.

Conditions

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Blood Flow

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

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)

Group Type EXPERIMENTAL

Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures

Intervention Type DIETARY_SUPPLEMENT

One packet once a day, after breakfast, for 12 week

Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo for 12 week

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo-Wan Chae

Principal Investigator, Clinical Trial Center for Functional Foods

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Soo Wan Chae, Ph.D., M.D.

Role: CONTACT

82-63-259-3040

Facility Contacts

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Soo-Wan Chae, MD., PhD

Role: primary

82-63-259-3040

Other Identifiers

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HJ-BF-AAM

Identifier Type: -

Identifier Source: org_study_id

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