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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 30, 2021

Interventions

  • 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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline proton density fat fraction of liver at 6 months
    • Time Frame: 0 and 6 months
    • Proton density fat fraction of liver: measured using magnetic resonance (MR)
  • Change from baseline liver fibrosis biomarker (Type pro-collagen III N terminal peptide) at 6 months
    • Time Frame: 0 and 6 months
    • Liver fibrosis biomarker 1: Type pro-collagen III N terminal peptide
  • Change from baseline liver fibrosis biomarker (hyaluronic acid) at 6 months
    • Time Frame: 0 and 6 months
    • Liver fibrosis biomarker 2: hyaluronic acid
  • Change from baseline liver fibrosis biomarker (laminin) at 6 months
    • Time Frame: 0 and 6 months
    • Liver fibrosis biomarker 3: laminin
  • Change from baseline liver fibrosis biomarker (collagen type IV) at 6 months
    • Time Frame: 0 and 6 months
    • Liver fibrosis biomarker 4: Collagen type IV
  • Change from baseline liver fibrosis biomarker (glycocholic acid) at 6 months
    • Time Frame: 0 and 6 months
    • Liver fibrosis biomarker 5: Glycocholic acid
  • Change from baseline NAFLD fibrosis score at 6 months
    • Time Frame: 0 and 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)

Secondary Measures

  • Change from baseline liver function biomarker (AST) at 6 months
    • Time Frame: 0 and 6 months
    • Liver function biomarkers 1: AST
  • Change from baseline liver function biomarker (ALT) at 6 months
    • Time Frame: 0 and 6 months
    • Liver function biomarkers 2: serum ALT
  • Change from baseline liver function biomarker (GGT) at 6 months
    • Time Frame: 0 and 6 months
    • Liver function biomarkers 3: serum gamma-glutamyl transpeptidase (GGT)
  • Change from baseline liver function biomarker (total protein) at 6 months
    • Time Frame: 0 and 6 months
    • Liver function biomarkers 4: serum total protein
  • Change from baseline liver function biomarker (ALP) at 6 months
    • Time Frame: 0 and 6 months
    • Liver function biomarkers 5: serum alkaline phosphatase (ALP)
  • Change from baseline liver function biomarker (bile acids) at 6 months
    • Time Frame: 0 and 6 months
    • Liver function biomarkers 6: serum bile acids
  • Change from baseline fasting blood lipid (TG) at 6 months
    • Time Frame: 0 and 6 months
    • Fasting blood lipid 1: serum triglycerides
  • Change from baseline fasting blood lipid (TC) at 6 months
    • Time Frame: 0 and 6 months
    • Fasting blood lipid 2: serum total cholesterol
  • Change from baseline fasting blood lipid (HDL-C) at 6 months
    • Time Frame: 0 and 6 months
    • Fasting blood lipid 3: serum high-density lipoprotein cholesterol (HDL-C)
  • Change from baseline fasting blood lipid (LDL-C) at 6 months
    • Time Frame: 0 and 6 months
    • Fasting blood lipid 4: serum low-density lipoprotein cholesterol (LDL-C)
  • Change from baseline fasting blood glucose at 6 months
    • Time Frame: 0 and 6 months
    • Fasting blood glucose: serum glucose
  • Change from baseline fasting blood insulin at 6 months
    • Time Frame: 0 and 6 months
    • Fasting blood insulin: serum insulin
  • Change from baseline systolic blood pressure at 6 months
    • Time Frame: 0 and 6 months
    • Blood pressure: systolic blood pressure
  • Change from baseline diastolic blood pressure at 6 months
    • Time Frame: 0 and 6 months
    • Blood pressure: diastolic blood pressure
  • Change from baseline Inflammatory factor (hsCRP ) at 6 months
    • Time Frame: 0 and 6 months
    • Inflammatory factor 1: serum high sensitivity C reactive protein (hsCRP)
  • Change from baseline Inflammatory factor (IL-6) at 6 months
    • Time Frame: 0 and 6 months
    • Inflammatory factor 2: serum IL-6
  • Change from baseline oxidative stress (SOD) at 6 months
    • Time Frame: 0 and 6 months
    • Oxidative stress biomarker 1: serum SOD
  • Change from baseline oxidative stress (MDA) at 6 months
    • Time Frame: 0 and 6 months
    • Oxidative stress biomarker 2: serum malondialdehyde (MDA)
  • Change from baseline fat mass at 6 months
    • Time Frame: 0 and 6 months
    • Fat mass (FM): FM (kg) at total body and sub-regions determined by a dual energy x-ray absorptiometry (DXA)
  • Change from baseline percentage fat mass at 6 months
    • Time Frame: 0 and 6 months
    • Percentage Fat mass (%FM): %FM (%) at total body and sub-regions determined by DXA

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sun Yat-sen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yu-ming Chen, Professor – Sun Yat-sen University

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