Efficacy and Safety of Fermented Ginseng Powder on Liver Function

Fatty Liver, Nonalcoholic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03260543
• Other study ID #: GB-LFE-GP
• Status: Completed
• Phase: N/A
• First received: March 23, 2017
• Last updated: February 1, 2018
• Start date: July 2016
• Est. completion date: August 2017

Study information

• Verified date: February 2018
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Fatty Liver, Nonalcoholic
• Non-alcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• fermented ginseng powder
tablets (2 tablets/day, 125 mg & 500 mg/day) for 12 weeks.
• Placebo
Placebo for 12 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of ALT(Alanine Transaminase)	Changes of ALT were assessed before and after the intervention	Baseline and 12 weeks
Secondary	Changes of Liver function index	Changes of AST were assessed before and after the intervention	Baseline and 12 weeks
Secondary	Changes of fatty liver grade	Changes of fatty liver grade were assessed before and after the intervention	Baseline and 12 weeks
Secondary	Changes of lipid metabolism index	Changes of lipid metabolism index were assessed before and after the intervention	Baseline and 12 weeks
Secondary	Changes of total antioxidant capacity	Changes of total antioxidant capacity were assessed before and after the intervention	Baseline and 12 weeks
Secondary	Changes of imflammation index	Changes of imflammation index were assessed before and after the intervention	Baseline and 12 weeks
Secondary	Changes of Multidimensional Fatigue Scale	Changes of Multidimensional Fatigue Scale were assessed before and after the intervention	Baseline and 12 weeks