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Efficacy and Safety of Fermented Ginseng Powder on Liver Function

Not Applicable
Completed
Conditions
Fatty Liver, Nonalcoholic
Interventions
Dietary Supplement: fermented ginseng powder
Dietary Supplement: Placebo
Registration Number
NCT03260543
Lead Sponsor
Chonbuk National University Hospital
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
90
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
fermented ginseng powderfermented ginseng powdertablets (2 tablets/day, 125 mg \& 500 mg/day) for 12 weeks.
PlaceboPlaceboPlacebo for 12 weeks.
Primary Outcome Measures
NameTimeMethod
Changes of ALT(Alanine Transaminase)Baseline and 12 weeks

Changes of ALT were assessed before and after the intervention

Secondary Outcome Measures
NameTimeMethod
Changes of imflammation indexBaseline and 12 weeks

Changes of imflammation index were assessed before and after the intervention

Changes of Liver function indexBaseline and 12 weeks

Changes of AST were assessed before and after the intervention

Changes of total antioxidant capacityBaseline and 12 weeks

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

Changes of fatty liver gradeBaseline and 12 weeks

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

Changes of Multidimensional Fatigue ScaleBaseline and 12 weeks

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

Changes of lipid metabolism indexBaseline and 12 weeks

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

Trial Locations

Locations (1)

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

🇰🇷

Jeonju, Jeollabuk-do, Korea, Republic of

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