Efficacy and Safety of Angelica Gigas N. Extract on Improvement of Blood Triglyceride

NCT ID: NCT03079648

Last Updated: 2019-12-19

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

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-02

Study Completion Date

2018-04-06

Brief Summary

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This study was conducted to investigate the effects of daily supplementation of Angelica gigas N. extract on improvement of Blood Triglyceride.

Detailed Description

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This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Twenty subjects were randomly divided into Angelica gigas N. extract or a placebo group. Fasting triglyceride profiles before and after the intervention.

Conditions

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Hyperlipidemias

Keywords

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Angelica gigas N. extract Hyperlipidemia Clinical Trial

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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Angelica gigas N. extract

capsules (2cap/d, 1,000mg/d) for 12 weeks.

Group Type EXPERIMENTAL

Angelica gigas N. extract

Intervention Type DIETARY_SUPPLEMENT

capsules (2cap/d, 1,000mg/d) for 12 weeks.

Placebo

Placebo for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo for 12 weeks

Interventions

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Angelica gigas N. extract

capsules (2cap/d, 1,000mg/d) for 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Age 19-80 years with Triglyceride 130-200 mg/dL

Exclusion Criteria

* Lipid lowering agent within past 6 months
* Severe cardiovascular disease(Mvocardial infarction, Stroke, etc)
* Renal disease(Heredity hyperlipidemia, Acute/Chronic renal failure, Nephrotic syndrome, etc)
* Cancer, Respiratory organ disease(Asthma, Chronic obstructive pulmonary disease)
* Autoimmune disease
* Diabetes mellitus
* Allergic or hypersensitive to any of the ingredients in the test products
* History of disease that could interfere with the test products or impede their absorption
* Under antipsychotic drugs therapy within past 2 months
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test by show the following results

* aspartate aminotransferase, alanine aminotransferase \> Reference range upper limit treble
* Serum Creatinine \> 2.0 mg/dl
* Pregnancy or breast feeding
* Not Contraception(except: Surgery for female infertility)
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

Countries

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South Korea

Other Identifiers

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WBP-HL-AG1

Identifier Type: -

Identifier Source: org_study_id