NCT05076058

Effects of Tablets of Silybum Marianum, Pueraria Lobate and Salvia Miltiorrhiza on Fatty Liver

Effects of Tablets of Silybum Marianum, Pueraria Lobate and Salvia Miltiorrhiza on the Progression of Fatty Liver in Adults: a Double-blinded Randomized Placebo-controlled Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Objectives: To examine the effects of tablets of silybum marianum, Pueraria lobate and salvia miltiorrhiza on the progression of fatty liver in patients with fatty liver. Design: a double-blinded randomized placebo-controlled clinical trial. Setting: community residents, Guangzhou city, South China. Participants: a total 118 men and women (18-65 years), with BMI range of 24-30 kg/m2, and with fatty liver screened by ultrasound or MR at baseline. Arms and Interventions: 118 participants were randomly allocated into two arms using a block randomization method. Experimental Arm: tablet of silybum marianum, Pueraria lobate and salvia miltiorrhiza, 3 tablets (1g each) twice a day for 6 months; Placebo Arm: placebo tablets, 3 tablets (1g each) twice a day for 6 months. Outcome Measures: determined at baseline and at 6 months post treatment 1. Primary Outcome Measures: 1) proton density fat fraction of liver assessed by MR; 2) serum liver fibrosis biomarkers: type procollagen III N terminal peptide, hyaluronic acid, laminin, collagen type IV, and glycocholic acid; 3) NAFLD fibrosis score. 2. Secondary Outcome Measures: 1) serum liver function biomarkers: AST, ALT, GGT, ALP, total protein, and bile acids; 2) fasting blood lipids: total triglycerides, total cholesterol, HDL cholesterol and LDL cholesterol; 3) fasting serum glucose and insulin; 4) serum inflammatory factors (hsCRP and IL-6); 5) oxidative stress: SOD and MDA; and 6) body measurements and body fat mass. Data Analyses: Mean changes in the above outcome measures from baseline to 6 months will be compared between the two arms.

Conditions

• Fatty Liver Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Tablet of silybum marianum, Pueraria lobate and salvia miltiorrhiza	Brand names: BY-HEALTH； Main contents (per 100g): silibinin 2g, salvianolic acid B 0.72g，Puerarin 0.68g
OTHER	Placebo tablet	Brand names: BY-HEALTH； Main contents : starch

Timeline

• Start date: 2021-03-01
• Primary completion: 2021-12-30
• Completion: 2022-06-30
• First posted: 2021-10-13
• Last updated: 2021-10-13

Locations

1 site across 1 country: China