Non-alcoholic Fatty Liver DiseaseNCT06167902
The Metabolic Effects of Ginseng Oligopeptide Preparation on Non- Alcoholic Fatty Liver Disease With Obesity: a Randomized Controlled Double-blind Trial
A study testing Ginseng oligopeptide (Ginseng extract） and Maltodextrin in people with Non-alcoholic Fatty Liver Disease, run by Peking Union Medical College Hospital.
Trial summary
To investigate the effect of ginseng oligopeptide on nonalcoholic fatty liver disease with obesity and clarify its intervention mechanism in theory, which will contribute to the prevention and treatment of non-alcoholic fatty liver more scientifically and effectively.The patients were randomly divided into two groups. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- Ginseng oligopeptide (Ginseng extract） and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 25 Dec 2023to 25 Dec 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria for non-alcoholic fatty liver disease ;
- Aged 18-65 years old;
- ALT, AST, GGT≤2×Upper Limit Of Normal（ULN）;
- BMI≥28Kg/㎡;
- Patients signed the relevant informed consent on a voluntary basis.
Who cannot join
- Under 18 years old and over 65 years old;
- Allergic to the ingredients of ginseng oligopeptide preparation;
- Serum ALT, AST, GGT>2ULN;
- Currently taking oral hepatoprotective drugs such as reduced glutathione, polyene phosphatidylcholine, and silibinin, etc.;
- Subjects participating in other clinical trials;
- Pregnant or lactating women;
- Complicated with serious diseases of the digestive system or other systems, such as chronic gastrointestinal diseases and chronic diseases causing digestive malabsorption,Kidney disease, hematological system or autoimmune diseases;
- Other populations that were deemed by the investigators to be ineligible for the trial may reduce or complicate enrollment patients with chemotherapy.
Trial locations and contacts
No sites are listed yet.
About this study
To investigate the effect of ginseng oligopeptide on nonalcoholic fatty liver disease with obesity and clarify its intervention mechanism in theory, which will contribute to the prevention and treatment of non-alcoholic fatty liver more scientifically and effectively.The patients were randomly divided into two groups. One group of patients took ginseng oligopeptide orally, and the other group took placebo. The liver function, blood lipid, blood glucose, liver B ultrasound and other indicators were observed to further determine the efficacy.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- Ginseng oligopeptide (Ginseng extract）, Maltodextrin
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginseng oligopeptide (Ginseng extract）Other
The experimental group was given ginseng oligopeptide preparation 1.2g per day orally.
MaltodextrinOther
The control group was treated with placebo maltodextrin 1.2g/d
| Study group | Role | What they receive |
|---|---|---|
| Ginseng oligopeptide group | Experimental | Not described Receives: Other: Ginseng oligopeptide (Ginseng extract） |
| The placebo group | Placebo comparator | Not described Receives: Other: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alanine aminotransferase (ALT)
Liver function
Measured: The day of enrollment, day 60 and day 120 after enrollment.
aspartate aminotransferase (AST)
Liver function
Measured: The day of enrollment, day 60 and day 120 after enrollment.
glutamyltransferase (GGT).
Liver function
Measured: The day of enrollment, day 60 and day 120 after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start25 Dec 2023 (estimated)
- Primary completion25 Dec 2024 (estimated)
- Study completion25 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167902
- Sponsor's protocol ID
- Ginseng oligopeptide 1.0
- Status last verified
- Dec 2023
- First submitted
- 29 Nov 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Metabolic Effects of Ginseng Oligopeptide Preparation on Non- Alcoholic Fatty Liver Disease With Obesity: a Randomized Controlled Double-blind Trial
- ClinicalTrials.gov ID
- NCT06167902
- Acronym / sponsor ID
- Ginseng oligopeptide 1.0
- Conditions
- Non-alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 25 Dec 2023 (estimated)
- Primary completion
- 25 Dec 2024 (estimated)
- Study completion
- 25 Dec 2025 (estimated)
- First posted
- 13 Dec 2023 (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.
To investigate the effect of ginseng oligopeptide on nonalcoholic fatty liver disease with obesity and clarify its intervention mechanism in theory, which will contribute to the prevention and treatment of non-alcoholic fatty liver more scientifically and effectively.The patients were randomly divided into two groups. One group of patients took ginseng oligopeptide orally, and the other group took placebo. The liver function, blood lipid, blood glucose, liver B ultrasound and other indicators were observed to further determine the efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ginseng oligopeptide group | Experimental | Other: Ginseng oligopeptide (Ginseng extract） |
| The placebo group | Placebo comparator | Other: Maltodextrin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meet the diagnostic criteria for non-alcoholic fatty liver disease ;
- Aged 18-65 years old;
- ALT, AST, GGT≤2×Upper Limit Of Normal（ULN）;
- BMI≥28Kg/㎡;
- Patients signed the relevant informed consent on a voluntary basis.
Key exclusion criteria (8 listed)
- Under 18 years old and over 65 years old;
- Allergic to the ingredients of ginseng oligopeptide preparation;
- Serum ALT, AST, GGT>2ULN;
- Currently taking oral hepatoprotective drugs such as reduced glutathione, polyene phosphatidylcholine, and silibinin, etc.;
- Subjects participating in other clinical trials;
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 |
|---|---|---|
| Ginseng oligopeptide (Ginseng extract）The experimental group was given ginseng oligopeptide preparation 1.2g per day orally. | Other | Ginseng oligopeptide group |
| MaltodextrinThe control group was treated with placebo maltodextrin 1.2g/d | Other | The placebo group |
Primary outcome
Alanine aminotransferase (ALT)
Time frame: The day of enrollment, day 60 and day 120 after enrollment.
Liver function
aspartate aminotransferase (AST)
Time frame: The day of enrollment, day 60 and day 120 after enrollment.
Liver function
glutamyltransferase (GGT).
Time frame: The day of enrollment, day 60 and day 120 after enrollment.
Liver function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Non-alcoholic Fatty Liver Disease
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
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.
Questions about this trial
What is this clinical trial studying?
A study testing Ginseng oligopeptide (Ginseng extract） and Maltodextrin in people with Non-alcoholic Fatty Liver Disease, run by Peking Union Medical College Hospital.
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 5 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: status not confirmed, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Chen, Doctor (13911006820, txchenwei@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alanine aminotransferase (ALT) (time frame: The day of enrollment, day 60 and day 120 after enrollment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2023.