NCT05497765

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nonalcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Silibinin extract, mixed power of pueraria, schisandra and salvia miltiorrhiza	Take 4 tablets with warm water twice a day
DIETARY_SUPPLEMENT	Silibinin extract	Take 4 tablets with warm water twice a day
DIETARY_SUPPLEMENT	Placebo	Take 4 tablets with warm water twice a day

Timeline

• Start date: 2022-08-01
• Primary completion: 2024-01-31
• Completion: 2024-02-20
• First posted: 2022-08-11
• Last updated: 2024-02-28

Locations

1 site across 1 country: China