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

Sun Yat-sen University

Status: Unknown

Conditions: Fatty Liver Disease

Treatments: Other: Placebo tablet; Dietary Supplement: Tablet of silybum marianum, Pueraria lobate and salvia miltiorrhiza

Study type: Interventional

Funder types: Other

Identifiers

NCT05076058

K19-51000-043

Details and patient eligibility

About

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.

Enrollment: 118 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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118 participants in 2 patient groups, including a placebo group

Treatment group

Experimental group

Description:

Tablet name: tablet of silybum marianum, Pueraria lobate and salvia miltiorrhiza; Dosage: 1g/tablet, 3 tablets/time； Frequency: 2 times/day; Duration: 6 months

Treatment:

Dietary Supplement: Tablet of silybum marianum, Pueraria lobate and salvia miltiorrhiza

Control group

Placebo Comparator group

Description:

Tablet name: Placebo; Dosage: 1g/tablet, 3 tablets/time； Frequency: 2 times/day; Duration: 6 months

Treatment:

Other: Placebo tablet