Liver DysfunctionNCT03945123
Effects of Red Ginseng on Liver Function
A study testing Red ginseng in people with Liver Dysfunction, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
Trial summary
Korea Red Ginseng (KRG) has effect on liver function Read more about this study
- Who is it for?
- Ages 37 to 63 years
- Conditions the study is for
- Liver Dysfunction
- What is being tested?
- Red ginseng
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2018to 31 Dec 2018
- 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 37 to 63 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- AST or ALT level > 50 IU/L
Who cannot join
- Viral hepatitis
- Alcoholic hepatitis
- Autoimmune hepatitis
- Pancreatitis
- Hemochromatosis
- Wilson's disease
- Drug induced liver injury
- Cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Korea Red Ginseng on Non-alcoholic Fatty Liver Disease
Korea Red Ginseng (KRG) has effect on liver function
Read the detailed description
Korea Red Ginseng (KRG) has been known as a natural product with anti-inflammatory effect in liver disease. Gut microbiota plays an important roles in the pathophysiology of nonalcoholic statohepatitis (NASH). We evaluated the effect of KRG on the pathophysiology of NASH
- Conditions
- Liver Dysfunction
- Being tested
- Red ginseng
- Keywords
- ginseng, Liver
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red ginsengDietary supplement
Also called Red ginseng tablet
Red ginseng tablet 120g
| Study group | Role | What they receive |
|---|---|---|
| Ginseng trial | Experimental | compare experimental group to controlled group Receives: Dietary Supplement: Red ginseng |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver enzyme
Decrease liver enzyme level
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start1 Jan 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
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 Liver DysfunctionStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki Tae Suk, Chuncheon Sacred Heart Hospital
- Investigators
- Ki Tae Suk, PhD.Md., Study chair, Chuncheon Sacred Heart HospitalJun Seok, MD., Principal investigator, Chuncheon Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945123
- Sponsor's protocol ID
- RIVER
- Status last verified
- May 2019
- First submitted
- 3 May 2019
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not yet
Publications
Hong JT, Lee MJ, Yoon SJ, Shin SP, Bang CS, Baik GH, Kim DJ, Youn GS, Shin MJ, Ham YL, Suk KT, Kim BS. Effect of Korea red ginseng on nonalcoholic fatty liver disease: an association of gut microbiota with liver function. J Ginseng Res. 2021 Mar;45(2):316-324. doi: 10.1016/j.jgr.2020.07.004. Epub 2020 Jul 16.
PubMed 33841012
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Korea Red Ginseng on Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT03945123
- Acronym / sponsor ID
- RIVER
- Conditions
- Liver Dysfunction
- Keywords
- ginseng, Liver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 10 May 2019 (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.
Korea Red Ginseng (KRG) has effect on liver function
Detailed description
Korea Red Ginseng (KRG) has been known as a natural product with anti-inflammatory effect in liver disease. Gut microbiota plays an important roles in the pathophysiology of nonalcoholic statohepatitis (NASH). We evaluated the effect of KRG on the pathophysiology of NASH
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ginseng trial | Experimental | Dietary Supplement: Red ginsengcompare experimental group to controlled group |
Who may qualify
- Ages
- 37 to 63 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- AST or ALT level > 50 IU/L
Key exclusion criteria (8 listed)
- Viral hepatitis
- Alcoholic hepatitis
- Autoimmune hepatitis
- Pancreatitis
- Hemochromatosis
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 |
|---|---|---|
| Red ginsengAlso: Red ginseng tabletRed ginseng tablet 120g | Dietary supplement | Ginseng trial |
Primary outcome
Liver enzyme
Time frame: 1year
Decrease liver enzyme level
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 10 May 2019.
- Derived from this study: PubMed 33841012Hong JT, Lee MJ, Yoon SJ, Shin SP, Bang CS, Baik GH, Kim DJ, Youn GS, Shin MJ, Ham YL, Suk KT, Kim BS. Effect of Korea red ginseng on nonalcoholic fatty liver disease: an association of gut microbiota with liver function. J Ginseng Res. 2021 Mar;45(2):316-324. doi: 10.1016/j.jgr.2020.07.004. Epub 2020 Jul 16.
- Individual participant dataSharing planned: No. Not yet
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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.
Ki Tae Suk, PhD.Md. study chair
Chuncheon Sacred Heart Hospital
Jun Seok, MD. principal investigator
Chuncheon Sacred Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red ginseng in people with Liver Dysfunction, run by Chuncheon Sacred Heart 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 8 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 10 May 2019. 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. 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?
Liver enzyme (time frame: 1year). 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 NCT03945123, 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 10 May 2019; AzTrials last refreshed its copy on 2 Nov 2026.