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

Guangzhou Medical University

Status

Completed

Conditions

Nonalcoholic Fatty Liver Disease

Treatments

Dietary Supplement: Silibinin extract, mixed power of pueraria, schisandra and salvia miltiorrhiza

Dietary Supplement: Placebo

Dietary Supplement: Silibinin extract

Study type

Interventional

Funder types

Other

Identifiers

NCT05497765

GDMUSPH001

Details and patient eligibility

About

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.

Full 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.

Enrollment

94 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

94 participants in 3 patient groups, including a placebo group

Compound silymarin

Experimental group

Description:

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

Treatment:

Dietary Supplement: Silibinin extract, mixed power of pueraria, schisandra and salvia miltiorrhiza

Silymarin

Active Comparator group

Description:

Dietary supplement: 4 tablets of silymarin twice a day for 12 weeks The active ingredient in each tablet: 81.6 mg of silibinin

Treatment:

Dietary Supplement: Silibinin extract

Placebo

Placebo Comparator group

Description:

Dietary supplement: 4 tablet of placebo twice a day for 12 weeks Placebo Composition: corn dextrin