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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
118
Brand names: BY-HEALTH； Main contents (per 100g): silibinin 2g, salvianolic acid B 0.72g，Puerarin 0.68g
Brand names: BY-HEALTH； Main contents : starch
Sun Yat-sen University
Guangzhou, Guangdong, China
Change from baseline proton density fat fraction of liver at 6 months
Proton density fat fraction of liver: measured using magnetic resonance (MR)
Time frame: 0 and 6 months
Change from baseline liver fibrosis biomarker (Type pro-collagen III N terminal peptide) at 6 months
Liver fibrosis biomarker 1: Type pro-collagen III N terminal peptide
Time frame: 0 and 6 months
Change from baseline liver fibrosis biomarker (hyaluronic acid) at 6 months
Liver fibrosis biomarker 2: hyaluronic acid
Time frame: 0 and 6 months
Change from baseline liver fibrosis biomarker (laminin) at 6 months
Liver fibrosis biomarker 3: laminin
Time frame: 0 and 6 months
Change from baseline liver fibrosis biomarker (collagen type IV) at 6 months
Liver fibrosis biomarker 4: Collagen type IV
Time frame: 0 and 6 months
Change from baseline liver fibrosis biomarker (glycocholic acid) at 6 months
Liver fibrosis biomarker 5: Glycocholic acid
Time frame: 0 and 6 months
Change from baseline NAFLD fibrosis score at 6 months
NAFLD fibrosis score: = -1.675 + 0.037 Age (yrs) + 0.094 BMI (kg/m2) + 1.13 impaired fasting glucose (IFG)/diabetes (yes = 1, no = 0) + 0.99 AST/ALT ratio - 0.013Platelet (\*10E9/L) - 0.66 Albumin (g/dl)
Time frame: 0 and 6 months
Change from baseline liver function biomarker (AST) at 6 months
Liver function biomarkers 1: AST
Time frame: 0 and 6 months
Change from baseline liver function biomarker (ALT) at 6 months
Liver function biomarkers 2: serum ALT
Time frame: 0 and 6 months
Change from baseline liver function biomarker (GGT) at 6 months
Liver function biomarkers 3: serum gamma-glutamyl transpeptidase (GGT)
Time frame: 0 and 6 months
Change from baseline liver function biomarker (total protein) at 6 months
Liver function biomarkers 4: serum total protein
Time frame: 0 and 6 months
Change from baseline liver function biomarker (ALP) at 6 months
Liver function biomarkers 5: serum alkaline phosphatase (ALP)
Time frame: 0 and 6 months
Change from baseline liver function biomarker (bile acids) at 6 months
Liver function biomarkers 6: serum bile acids
Time frame: 0 and 6 months
Change from baseline fasting blood lipid (TG) at 6 months
Fasting blood lipid 1: serum triglycerides
Time frame: 0 and 6 months
Change from baseline fasting blood lipid (TC) at 6 months
Fasting blood lipid 2: serum total cholesterol
Time frame: 0 and 6 months
Change from baseline fasting blood lipid (HDL-C) at 6 months
Fasting blood lipid 3: serum high-density lipoprotein cholesterol (HDL-C)
Time frame: 0 and 6 months
Change from baseline fasting blood lipid (LDL-C) at 6 months
Fasting blood lipid 4: serum low-density lipoprotein cholesterol (LDL-C)
Time frame: 0 and 6 months
Change from baseline fasting blood glucose at 6 months
Fasting blood glucose: serum glucose
Time frame: 0 and 6 months
Change from baseline fasting blood insulin at 6 months
Fasting blood insulin: serum insulin
Time frame: 0 and 6 months
Change from baseline systolic blood pressure at 6 months
Blood pressure: systolic blood pressure
Time frame: 0 and 6 months
Change from baseline diastolic blood pressure at 6 months
Blood pressure: diastolic blood pressure
Time frame: 0 and 6 months
Change from baseline Inflammatory factor (hsCRP ) at 6 months
Inflammatory factor 1: serum high sensitivity C reactive protein (hsCRP)
Time frame: 0 and 6 months
Change from baseline Inflammatory factor (IL-6) at 6 months
Inflammatory factor 2: serum IL-6
Time frame: 0 and 6 months
Change from baseline oxidative stress (SOD) at 6 months
Oxidative stress biomarker 1: serum SOD
Time frame: 0 and 6 months
Change from baseline oxidative stress (MDA) at 6 months
Oxidative stress biomarker 2: serum malondialdehyde (MDA)
Time frame: 0 and 6 months
Change from baseline fat mass at 6 months
Fat mass (FM): FM (kg) at total body and sub-regions determined by a dual energy x-ray absorptiometry (DXA)
Time frame: 0 and 6 months
Change from baseline percentage fat mass at 6 months
Percentage Fat mass (%FM): %FM (%) at total body and sub-regions determined by DXA
Time frame: 0 and 6 months
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