Skip to main content
OpenTrials
Completed

NCT Number: NCT03260543

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fatty Liver, Nonalcoholic Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fermented ginseng powder

Dietary Supplement

tablets (2 tablets/day, 125 mg & 500 mg/day) for 12 weeks.

Placebo

Dietary Supplement

Placebo for 12 weeks.

Primary outcomes

  1. Changes of ALT(Alanine Transaminase)

    Time frame: Baseline and 12 weeks

    Changes of ALT were assessed before and after the intervention

Secondary outcomes

  1. Changes of Liver function index

    Time frame: Baseline and 12 weeks

    Changes of AST were assessed before and after the intervention

  2. Changes of fatty liver grade

    Time frame: Baseline and 12 weeks

    Changes of fatty liver grade were assessed before and after the intervention

  3. Changes of lipid metabolism index

    Time frame: Baseline and 12 weeks

    Changes of lipid metabolism index were assessed before and after the intervention

  4. Changes of total antioxidant capacity

    Time frame: Baseline and 12 weeks

    Changes of total antioxidant capacity were assessed before and after the intervention

  5. Changes of imflammation index

    Time frame: Baseline and 12 weeks

    Changes of imflammation index were assessed before and after the intervention

  6. Changes of Multidimensional Fatigue Scale

    Time frame: Baseline and 12 weeks

    Changes of Multidimensional Fatigue Scale were assessed before and after the intervention

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Aug 24, 2017
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.