Back to resultsEfficacy and Safety of Fermented Ginseng Powder on Liver Function
Primary Purpose
Fatty Liver, Nonalcoholic
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
fermented ginseng powder
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Fatty Liver, Nonalcoholic focused on measuring ginseng powder, Fatty Liver, Clinical Trial
Eligibility Criteria
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.
Sites / Locations
- Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
fermented ginseng powder
Placebo
Arm Description
tablets (2 tablets/day, 125 mg & 500 mg/day) for 12 weeks.
Placebo for 12 weeks.
Outcomes
Primary Outcome Measures
Changes of ALT(Alanine Transaminase)
Changes of ALT were assessed before and after the intervention
Secondary Outcome Measures
Changes of Liver function index
Changes of AST were assessed before and after the intervention
Changes of fatty liver grade
Changes of fatty liver grade were assessed before and after the intervention
Changes of lipid metabolism index
Changes of lipid metabolism index were assessed before and after the intervention
Changes of total antioxidant capacity
Changes of total antioxidant capacity were assessed before and after the intervention
Changes of imflammation index
Changes of imflammation index were assessed before and after the intervention
Changes of Multidimensional Fatigue Scale
Changes of Multidimensional Fatigue Scale were assessed before and after the intervention
Full Information
NCT ID
NCT03260543
First Posted
March 23, 2017
Last Updated
February 1, 2018
Sponsor
Chonbuk National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03260543
Brief Title
Efficacy and Safety of Fermented Ginseng Powder on Liver Function
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonbuk National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatty Liver, Nonalcoholic
Keywords
ginseng powder, Fatty Liver, Clinical Trial
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fermented ginseng powder
Arm Type
Experimental
Arm Description
tablets (2 tablets/day, 125 mg & 500 mg/day) for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
fermented ginseng powder
Intervention Description
tablets (2 tablets/day, 125 mg & 500 mg/day) for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo for 12 weeks.
Primary Outcome Measure Information:
Title
Changes of ALT(Alanine Transaminase)
Description
Changes of ALT were assessed before and after the intervention
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Changes of Liver function index
Description
Changes of AST were assessed before and after the intervention
Time Frame
Baseline and 12 weeks
Title
Changes of fatty liver grade
Description
Changes of fatty liver grade were assessed before and after the intervention
Time Frame
Baseline and 12 weeks
Title
Changes of lipid metabolism index
Description
Changes of lipid metabolism index were assessed before and after the intervention
Time Frame
Baseline and 12 weeks
Title
Changes of total antioxidant capacity
Description
Changes of total antioxidant capacity were assessed before and after the intervention
Time Frame
Baseline and 12 weeks
Title
Changes of imflammation index
Description
Changes of imflammation index were assessed before and after the intervention
Time Frame
Baseline and 12 weeks
Title
Changes of Multidimensional Fatigue Scale
Description
Changes of Multidimensional Fatigue Scale were assessed before and after the intervention
Time Frame
Baseline and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
54907
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32425736
Citation
Jung SJ, Hwang JH, Park SH, Choi EK, Ha KC, Baek HI, Shin DG, Seo JH, Chae SW. A 12-week, randomized, double-blind study to evaluate the efficacy and safety of liver function after using fermented ginseng powder (GBCK25). Food Nutr Res. 2020 Apr 6;64. doi: 10.29219/fnr.v64.3517. eCollection 2020.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Fermented Ginseng Powder on Liver Function
We'll reach out to this number within 24 hrs