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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

94

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Guangzhou Medical University

Collaborators

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)

August 1, 2022

Primary Completion (Actual)

January 31, 2024

Study Completion (Actual)

February 20, 2024

Study Registration Dates

First Submitted

August 8, 2022

First Submitted That Met QC Criteria

August 9, 2022

First Posted (Actual)

August 11, 2022

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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