Fatty Liver, NonalcoholicNCT03260543
Efficacy and Safety of Fermented Ginseng Powder on Liver Function
A study testing fermented ginseng powder in people with Fatty Liver, Nonalcoholic, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial summary
This study was conducted to investigate the effects of daily supplementation of fermented ginseng powder on improvement of Liver function. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatty Liver, Nonalcoholic
- What is being tested?
- fermented ginseng powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 19-70 years with ALT 35-105 IU/L
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
About this study
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
This study was conducted to investigate the effects of daily supplementation of fermented ginseng powder on improvement of Liver function.
Read the 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.
- Conditions
- Fatty Liver, Nonalcoholic
- Being tested
- fermented ginseng powder, Placebo
- Keywords
- ginseng powder, Fatty Liver, Clinical Trial
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fermented ginseng powderDietary supplement
tablets (2 tablets/day, 125 mg \& 500 mg/day) for 12 weeks.
PlaceboDietary supplement
Placebo for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| fermented ginseng powder | Experimental | tablets (2 tablets/day, 125 mg \& 500 mg/day) for 12 weeks. Receives: Dietary Supplement: fermented ginseng powder |
| Placebo | Placebo comparator | Placebo for 12 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of ALT(Alanine Transaminase)
Changes of ALT were assessed before and after the intervention
Measured: Baseline and 12 weeks
Secondary outcomes (6)
Changes of Liver function index
Changes of AST were assessed before and after the intervention
Measured: Baseline and 12 weeks
Changes of fatty liver grade
Changes of fatty liver grade were assessed before and after the intervention
Measured: Baseline and 12 weeks
Changes of lipid metabolism index
Changes of lipid metabolism index were assessed before and after the intervention
Measured: Baseline and 12 weeks
Changes of total antioxidant capacity
Changes of total antioxidant capacity were assessed before and after the intervention
Measured: Baseline and 12 weeks
Changes of imflammation index
Changes of imflammation index were assessed before and after the intervention
Measured: Baseline and 12 weeks
Changes of Multidimensional Fatigue Scale
Changes of Multidimensional Fatigue Scale were assessed before and after the intervention
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study startJul 2016
- Primary completionNov 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fatty Liver, NonalcoholicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Wan Chae, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260543
- Sponsor's protocol ID
- GB-LFE-GP
- Status last verified
- Feb 2018
- First submitted
- 23 Mar 2017
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32425736
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03260543
- Acronym / sponsor ID
- GB-LFE-GP
- Conditions
- Fatty Liver, Nonalcoholic
- Keywords
- ginseng powder, Fatty Liver, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 24 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fermented ginseng powder | Experimental | Dietary Supplement: fermented ginseng powdertablets (2 tablets/day, 125 mg \& 500 mg/day) for 12 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo for 12 weeks. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 19-70 years with ALT 35-105 IU/L
Key exclusion criteria (6 listed)
- 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
- Pregnancy or breast feeding etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fermented ginseng powdertablets (2 tablets/day, 125 mg \& 500 mg/day) for 12 weeks. | Dietary supplement | fermented ginseng powder |
| PlaceboPlacebo for 12 weeks. | Dietary supplement | Placebo |
Primary outcome
Changes of ALT(Alanine Transaminase)
Time frame: Baseline and 12 weeks
Changes of ALT were assessed before and after the intervention
6 secondary outcomes
Changes of Liver function index
Time frame: Baseline and 12 weeks
Changes of fatty liver grade
Time frame: Baseline and 12 weeks
Changes of lipid metabolism index
Time frame: Baseline and 12 weeks
Changes of total antioxidant capacity
Time frame: Baseline and 12 weeks
Changes of imflammation index
Time frame: Baseline and 12 weeks
Changes of Multidimensional Fatigue Scale
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Derived from this study: PubMed 32425736Jung 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fermented ginseng powder in people with Fatty Liver, Nonalcoholic, run by Chonbuk National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of ALT(Alanine Transaminase) (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03260543, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.