Efficacy and Safety of Fermented Ginseng Powder on Liver Function

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

Detailed Description
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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.

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

Conditions
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Fatty Liver, Nonalcoholic

Intervention / Treatment
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* Dietary Supplement: fermented ginseng powder
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fermented ginseng powder<br>tablets (2 tablets/day, 125 mg & 500 mg/day) for 12 weeks. | Dietary Supplement: fermented ginseng powder<br>* tablets (2 tablets/day, 125 mg & 500 mg/day) for 12 weeks.<br>|
| Placebo Comparator: Placebo<br>Placebo for 12 weeks. | Dietary Supplement: Placebo<br>* Placebo for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of ALT(Alanine Transaminase) | 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 | Changes of AST were assessed before and after the intervention | Baseline and 12 weeks | 
| Changes of fatty liver grade | Changes of fatty liver grade were assessed before and after the intervention | Baseline and 12 weeks | 
| Changes of lipid metabolism index | Changes of lipid metabolism index were assessed before and after the intervention | Baseline and 12 weeks | 
| Changes of total antioxidant capacity | Changes of total antioxidant capacity were assessed before and after the intervention | Baseline and 12 weeks | 
| Changes of imflammation index | Changes of imflammation index were assessed before and after the intervention | Baseline and 12 weeks | 
| Changes of Multidimensional Fatigue Scale | Changes of Multidimensional Fatigue Scale were assessed before and after the intervention | Baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ginseng powder, Fatty Liver, Clinical Trial