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The Metabolic Effects of Ginseng Oligopeptide Preparation on Non- Alcoholic Fatty Liver Disease With Obesity: a Randomized Controlled Double-blind Trial

The Metabolic Effects of Ginseng Oligopeptide Preparation on Non- Alcoholic Fatty Liver Disease With Obesity: a Randomized Controlled Double-blind Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06167902
Enrollment
200
Registered
2023-12-13
Start date
2023-12-25
Completion date
2025-12-25
Last updated
2023-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic Fatty Liver Disease

Brief 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. 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.

Interventions

OTHERGinseng oligopeptide (Ginseng extract)

The experimental group was given ginseng oligopeptide preparation 1.2g per day orally.

OTHERMaltodextrin

The control group was treated with placebo maltodextrin 1.2g/d

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Alanine aminotransferase (ALT)The day of enrollment, day 60 and day 120 after enrollment.Liver function
aspartate aminotransferase (AST)The day of enrollment, day 60 and day 120 after enrollment.Liver function
glutamyltransferase (GGT).The day of enrollment, day 60 and day 120 after enrollment.Liver function

Contacts

Primary ContactWei Chen, Doctor
txchenwei@sina.com13911006820

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026