Fatty Liver, Nonalcoholic
Conditions
Keywords
ginseng powder, Fatty Liver, Clinical Trial
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.
Interventions
DIETARY_SUPPLEMENTfermented ginseng powder
tablets (2 tablets/day, 125 mg & 500 mg/day) for 12 weeks.
DIETARY_SUPPLEMENTPlacebo
Placebo for 12 weeks.
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of ALT(Alanine Transaminase) | Baseline and 12 weeks | Changes of ALT were assessed before and after the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of fatty liver grade | Baseline and 12 weeks | Changes of fatty liver grade were assessed before and after the intervention |
| Changes of lipid metabolism index | Baseline and 12 weeks | Changes of lipid metabolism index were assessed before and after the intervention |
| Changes of Liver function index | Baseline and 12 weeks | Changes of AST were assessed before and after the intervention |
| Changes of imflammation index | Baseline and 12 weeks | Changes of imflammation index were assessed before and after the intervention |
| Changes of Multidimensional Fatigue Scale | Baseline and 12 weeks | Changes of Multidimensional Fatigue Scale were assessed before and after the intervention |
| Changes of total antioxidant capacity | Baseline and 12 weeks | Changes of total antioxidant capacity were assessed before and after the intervention |
Countries
South Korea
Outcome results
None listed