Efficacy and Safety of Fermented Ginseng Powder on Liver Function
A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Fermented Ginseng Powder on Liver Function
1 other identifier
interventional
90
1 country
1
Brief Summary
This study was conducted to investigate the effects of daily supplementation of fermented ginseng powder on improvement of Liver function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 23, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedFirst Posted
Study publicly available on registry
August 24, 2017
CompletedFebruary 5, 2018
February 1, 2018
4 months
March 23, 2017
February 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes of ALT(Alanine Transaminase)
Changes of ALT were assessed before and after the intervention
Baseline and 12 weeks
Secondary Outcomes (6)
Changes of Liver function index
Baseline and 12 weeks
Changes of fatty liver grade
Baseline and 12 weeks
Changes of lipid metabolism index
Baseline and 12 weeks
Changes of total antioxidant capacity
Baseline and 12 weeks
Changes of imflammation index
Baseline and 12 weeks
- +1 more secondary outcomes
Study Arms (2)
fermented ginseng powder
EXPERIMENTALtablets (2 tablets/day, 125 mg \& 500 mg/day) for 12 weeks.
Placebo
PLACEBO COMPARATORPlacebo for 12 weeks.
Interventions
tablets (2 tablets/day, 125 mg \& 500 mg/day) for 12 weeks.
Eligibility Criteria
You may qualify if:
- Age 19-70 years with ALT 35-105 IU/L
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907, South Korea
Related Publications (1)
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.
PMID: 32425736DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Clinical Trial Center for Functional Foods
Study Record Dates
First Submitted
March 23, 2017
First Posted
August 24, 2017
Study Start
July 1, 2016
Primary Completion
November 1, 2016
Study Completion
August 1, 2017
Last Updated
February 5, 2018
Record last verified: 2018-02