Efficacy and Safety of Fermented Ginseng Powder on Liver Function

February 1, 2018 updated by: Soo-Wan Chae, Chonbuk National University Hospital

A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Fermented Ginseng Powder on Liver Function

This study was conducted to investigate the effects of daily supplementation of fermented ginseng powder on improvement of Liver function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of fermented ginseng powder on improvement of Liver function. The investigators measured ALT(Alanine Transaminase) profiles, Liver function index, fatty liver grade, lipid metabolism index, total antioxidant capacity, imflammation index, and Multidimensional Fatigue Scale.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
        • Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 19-70 years with ALT 35-105 IU/L

Exclusion Criteria:

  • 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

    • Serum Creatinine > 2.0 mg/dl
  • Pregnancy or breast feeding etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo for 12 weeks.
Dietary supplement: Placebo
Placebo for 12 weeks.
Experimental: fermented ginseng powder
tablets (2 tablets/day, 125 mg & 500 mg/day) for 12 weeks.
Dietary supplement: fermented ginseng powder
tablets (2 tablets/day, 125 mg & 500 mg/day) for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of ALT(Alanine Transaminase)
Time Frame: Baseline and 12 weeks
Changes of ALT were assessed before and after the intervention
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of Liver function index
Time Frame: Baseline and 12 weeks
Changes of AST were assessed before and after the intervention
Baseline and 12 weeks
Changes of fatty liver grade
Time Frame: Baseline and 12 weeks
Changes of fatty liver grade were assessed before and after the intervention
Baseline and 12 weeks
Changes of lipid metabolism index
Time Frame: Baseline and 12 weeks
Changes of lipid metabolism index were assessed before and after the intervention
Baseline and 12 weeks
Changes of total antioxidant capacity
Time Frame: Baseline and 12 weeks
Changes of total antioxidant capacity were assessed before and after the intervention
Baseline and 12 weeks
Changes of imflammation index
Time Frame: Baseline and 12 weeks
Changes of imflammation index were assessed before and after the intervention
Baseline and 12 weeks
Changes of Multidimensional Fatigue Scale
Time Frame: Baseline and 12 weeks
Changes of Multidimensional Fatigue Scale were assessed before and after the intervention
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chonbuk National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

March 23, 2017

First Submitted That Met QC Criteria

August 21, 2017

First Posted (Actual)

August 24, 2017

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

February 1, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GB-LFE-GP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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