An Intervention Study of Compound Silymarin in Patients With Non-alcoholic Fatty Liver Disease

February 26, 2024 updated by: Honghui Guo, Guangzhou Medical University

Effects of Compound Silymarin on Biomarkers of Lipid Metabolism and Inflammation in Patients With Non-alcoholic Fatty Liver Disease: A Randomized Controlled Double-blind Trial

Non-alcoholic fatty liver disease (NAFLD) has become the most prevalent liver disorder in China. The aim of this project is to evaluate the effects of compound silymarin on biomarkers of lipid metabolism and inflammation in the patients with NAFLD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Non-alcoholic fatty liver disease (NAFLD) has become the most prevalent liver disorder in China but still has no exact therapy for this disease instead of improving our diet and enhancing physical activity. Silymarin is a mixture of flavonoids extracted from seeds of Silybum marianum or milk thistle, and its major active compound is silibinin. Because of its antioxidant, anti-inflammatory and antifibrotic power, silymarin has important biological effects in NAFLD. Furthermore, some traditional liver protective Chinese medicines are also helpful in controlling the progression of NAFLD, such as pueraria, schisandra and salvia miltiorrhiza. At present, there are few reports on the combination of silymarin and these traditional Chinese medicines in the treatment of NAFLD. This study aims to test the effect of compound silymarin on laboratory markers and clinical evolution of patients with NAFLD.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
94

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Dongguan, Guangdong, China, 523808
        • Department of Nutrition, School of Public Health, Guangdong Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject's BMI is ≥ 22.0 kg/m2 and < 33.0 kg/m2;
  • Subject is diagnosed with NAFLD according to the Chinese Non-alcoholic fatty liver disease prevention guide 2018;
  • A mildly elevated of ALT level (≥ 30 U/L for male, ≥ 19 U/L for female) or an AST/ALT ratio < 1.0;
  • Must be able to swallow tablets.

Exclusion Criteria:

  • ≥ 30 grams of alcohol/day for male and ≥ 20 grams of alcohol/day for female;
  • Patients with certain hepatic diseases such as gallstones, hepatitis C, autoimmune hepatitis, and hepatolenticular degeneration which can lead to fatty liver disease;
  • Be taking medicines or supplements that would influence the liver function, lipid metabolism;
  • Patients with total parenteral nutrition, inflammatory bowel disease, celiac disease, hypothyroidism, Cushing syndrome, Mauriac syndrome, etc;
  • Patients with hereditary diseases, coronary heart disease, mental disorder, cancer, cirrhosis and renal disease;
  • Body weight change are more than 10% in previous 3 months;
  • Patients who have participated in or are participating in other clinical trials within 3 months of their first administration of the study product;
  • Subjects are allergic to the ingredients in the test or control samples;
  • Woman who is pregnant or breastfeeding;
  • Subjects cannot meet the requirements of compliance in the pre-experiment period;
  • Subjects who fail to sign the informed consent forms.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Compound silymarin
Dietary supplement: 4 tablets of compound silymarin twice a day for 12 weeks The active ingredient in each tablet: 81.6 mg of silibinin, mixed power of pueraria, schisandra and salvia miltiorrhiza
Dietary supplement: Silibinin extract, mixed power of pueraria, schisandra and salvia miltiorrhiza
Take 4 tablets with warm water twice a day
Active Comparator: Silymarin
Dietary supplement: 4 tablets of silymarin twice a day for 12 weeks The active ingredient in each tablet: 81.6 mg of silibinin
Dietary supplement: Silibinin extract
Take 4 tablets with warm water twice a day
Placebo Comparator: Placebo
Dietary supplement: 4 tablet of placebo twice a day for 12 weeks Placebo Composition: corn dextrin
Dietary supplement: Placebo
Take 4 tablets with warm water twice a day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Liver enzymes
Time Frame: Change from baseline ALT and AST at 12 weeks
Serum activities of alanine transaminase (ALT) and aspartate transaminase (AST)
Change from baseline ALT and AST at 12 weeks
Lipid profile
Time Frame: Change from baseline lipid profile at 12 weeks
Serum levels of total cholesterol (TC), triglyceride (TG), high density lipoprotein-cholesterol (HDL-C) and low density lipoprotein-cholesterol (LDL-C)
Change from baseline lipid profile at 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
T-Lymphocytes' composition
Time Frame: Change from baseline T-Lymphocytes' composition at 12 weeks
Changes of T-Lymphocytes' composition in peripheral blood
Change from baseline T-Lymphocytes' composition at 12 weeks
Bile acid metabolism
Time Frame: Change from baseline composition of serum and fecal bile acids at 12 weeks
Composition of serum and fecal bile acids
Change from baseline composition of serum and fecal bile acids at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangzhou Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Affiliated Hospital of Guangdong Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GDMUSPH001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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