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

NCT ID: NCT06167902

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-25

Study Completion Date

2025-12-25

Brief Summary

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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.

Detailed Description

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Conditions

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Non-alcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ginseng oligopeptide group

Group Type EXPERIMENTAL

Ginseng oligopeptide (Ginseng extract)

Intervention Type OTHER

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

The placebo group

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type OTHER

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

Interventions

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Ginseng oligopeptide (Ginseng extract)

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

Intervention Type OTHER

Maltodextrin

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Wei Chen, Doctor

Role: CONTACT

Phone: 13911006820

Email: [email protected]

Other Identifiers

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Ginseng oligopeptide 1.0

Identifier Type: -

Identifier Source: org_study_id