Efficacy and Safety of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level

NCT ID: NCT03828188

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

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-05-08

Brief Summary

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This study was conducted to investigate the effects of daily supplementation of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level.

Detailed Description

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This study was a 12-week, randomized, double-blind, placebo-controlled 2x2 cross-over design human trial. 50 subjects which of 25 by group were randomly divided into Red Ginseng Concentrated Powder and a placebo group.(A total of 100 subjects completed the 2x2 cross-over study.)

Conditions

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Hyperlipidemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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group A

Red Ginseng Concentrated Powder in 12 weeks → rest in 4 weeks → Placebo 12 weeks.

* Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day)
* Placebo: Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day)

Group Type EXPERIMENTAL

Red Ginseng Concentrated Powder

Intervention Type DIETARY_SUPPLEMENT

Red Ginseng Concentrated Powder(4.9 g/day) for 12 weeks.

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo for 12 weeks.

group B

Placebo 12 weeks→ rest in 4 weeks → Red Ginseng Concentrated Powder in 12 weeks.

* Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day)
* Placebo: Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day)

Group Type EXPERIMENTAL

Red Ginseng Concentrated Powder

Intervention Type DIETARY_SUPPLEMENT

Red Ginseng Concentrated Powder(4.9 g/day) for 12 weeks.

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo for 12 weeks.

Interventions

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Red Ginseng Concentrated Powder

Red Ginseng Concentrated Powder(4.9 g/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 19-70 years with Triglyceride 120-200 mg/dL

Exclusion Criteria

* Lipid lowering agent within past 6 months
* Those with clinically significant severe cardiovascular, endocrine, immune, respiratory, liver, biliary, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders
* Persons with significant hypersensitivity reactions to ginseng and red ginseng
* Those with a history of gastrointestinal disorders (ex, Crohn's disease) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of a product for clinical trials
* Those who have received antipsychotic medication within 2 months before screening
* Those with a history of alcoholism or substance abuse
* Those who participated in other clinical trials within 2 months before screening
* Laboratory test by show the following results

* Aspartate Transaminase(AST), Alanine Transaminase(ALT) \> Reference range 3 times upper limit
* Serum Creatinine \> 2.0 mg/dL
* Pregnancy or breast feeding
* Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
* Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 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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JAR-FHL-RG2

Identifier Type: -

Identifier Source: org_study_id

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