Efficacy and Safety of Angelica Gigas N. Extract on Improvement of Hyperglycemia

NCT ID: NCT03258229

Last Updated: 2019-08-22

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-09

Study Completion Date

2017-12-07

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 Hyperglycemia .

Detailed Description

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This study was a 8 weeks, randomized, double-blind, placebo-controlled 2×2 cross-over design human trial. Twenty subjects were randomly divided into Angelica gigas N. extract or a placebo group. Fasting and postprandial glucose profiles during oral glucose tolerance test (OGTT) were assessed before and after the intervention.

Conditions

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Hyperglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

2×2 cross-over Assignment
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 8 weeks.

Group Type EXPERIMENTAL

Angelica gigas N. extract

Intervention Type DIETARY_SUPPLEMENT

capsules(2cap/d, 1,000mg/d) for 8 weeks.

Placebo

Placebo for 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo for 8 weeks

Interventions

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Angelica gigas N. extract

capsules(2cap/d, 1,000mg/d) for 8 weeks.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Age 20-80 years with fasting glucose 100-125 mg/dL or 2 hour postprandial glucose 140-199 mg/dl

Exclusion Criteria

* Weight less than 48 kg or weight decreased by more than 10% within past 3 months
* Hypoglycemic agent, Obesity medicine, Lipid lowering agent within past 6 months or Blood sugar, Obesity and Lipid improvement functional foods within past 2 weeks
* Treated with corticosteroid within past 4 weeks
* Severe cardiovascular disease(Mvocardial infarction, Stroke, etc)
* Renal disease(Heredity hyperlipidemia, Acute/Chronic renal failure, Nephrotic syndrome, etc)
* Rheumatoid arthritis, Autoimmune disease
* Cancer, Respiratory organ disease(Asthma, Chronic obstructive pulmonary disease)
* 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

20 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-HG-AG2

Identifier Type: -

Identifier Source: org_study_id

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