Clinical trial NCT05497765: An Intervention Study of Compound Silymarin in Patients With Non-alcoholic Fatty Liver Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonalcoholic Fatty Liver Disease
Keywords: Nonalcoholic fatty liver disease
Silymarin
Inflammation
Lipid metabolism
Lead sponsor: Guangzhou Medical University
Sponsor class: OTHER
Collaborators: name: Affiliated Hospital of Guangdong Medical University
First posted: 2022-08-11
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Liver enzymes
timeFrame: Change from baseline ALT and AST at 12 weeks
measure: Lipid profile
timeFrame: Change from baseline lipid profile at 12 weeks
Secondary outcomes:
measure: T-Lymphocytes' composition
timeFrame: Change from baseline T-Lymphocytes' composition at 12 weeks
measure: Bile acid metabolism
timeFrame: Change from baseline composition of serum and fecal bile acids at 12 weeks
Other outcomes:
Locations:
city: Dongguan
country: China
facility: Department of Nutrition, School of Public Health, Guangdong Medical University
state: Guangdong
Study officials:
References:
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