Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Hyperglycemia

NCT ID: NCT03775733

Last Updated: 2020-05-08

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

2018-09-07

Study Completion Date

2020-12-31

Brief Summary

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This study was conducted to investigate the effects of daily supplementation of hydrolysed red ginseng extract on improvement of Hyperglycemia.

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 Hydrolysed Red Ginseng 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

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Hydrolysed red ginseng extract

Hydrolysed red ginseng extract 2.4g/day for 12 weeks

Group Type EXPERIMENTAL

Hydrolysed Red Ginseng Extract

Intervention Type DIETARY_SUPPLEMENT

Hydrolysed Red Ginseng Extract 2.4g/day 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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Hydrolysed Red Ginseng Extract

Hydrolysed Red Ginseng Extract 2.4g/day 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 fasting glucose 100-140 mg/dL

Exclusion Criteria

* Weight less than 48 kg or weight decreased by more than 10% within past 3 months
* Have clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, hepatic biliary system, kidney and Urinary system, neuropsychiatry, musculoskeletal, inflammatory and hematologic malignancies, gastrointestinal disorders, etc.
* Hypoglycemic agent, Obesity medicine, Lipid lowering agent within past 3 months
* Blood sugar improvement or healthy functional food within past 1 month
* Under antipsychotic medication 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 3 times upper limit
* Serum Creatinine \> 2.0 mg/dl
* Pregnancy or breast feeding
* If a woman of childbearing doesn't accept the implementation of appropriate contraception
* Principal Investigator judged inappropriate for participation in study because of 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

Facility Contacts

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Soo-Wan Chae, MD., PhD

Role: primary

82-63-259-3040

Other Identifiers

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GH-HG-HR

Identifier Type: -

Identifier Source: org_study_id

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