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

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.

Inclusion Criteria:

• Age: 18-65 years
• BMI: 24-30 kg/m2
• Fatty liver, assessed by ultrasound or MR
• Had normal diet and normal daily life.

Exclusion Criteria:

• Hospital confirmed diseases of heart, liver (viral hepatitis, drug-induced liver injury, cirrhosis), kidney, brain, hematopoietic system，diabetes, immune system, and cancer；
• Taking medicine or supplements known to affect fatty liver, body fat;
• Body weight had changed more than 10% within the past 3 months;
• Physical or mental disabled to participate the trial;
• Compliance of tablet consumption is/was less than 80% in run-in period;
• Pregnant or lactating women, or intended pregnancy during the trial period;
• Be allergic to the proposed supplements；
• Attended or plan to attend other trial(s);
• Be unwell to sign the informed consent form, or have other conditions that be not suitable to attend the trial considered by the investigators.