Effects of Tablets of Silybum Marianum, Pueraria Lobate and Salvia Miltiorrhiza on Fatty Liver
- Conditions
- Fatty Liver Disease
- Interventions
- Other: Placebo tabletDietary Supplement: Tablet of silybum marianum, Pueraria lobate and salvia miltiorrhiza
- Registration Number
- NCT05076058
- Lead Sponsor
- Sun Yat-sen University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 118
- Age: 18-65 years
- BMI: 24-30 kg/m2
- Fatty liver, assessed by ultrasound or MR
- Had normal diet and normal daily life.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Placebo tablet Tablet name: Placebo; Dosage: 1g/tablet, 3 tablets/time； Frequency: 2 times/day; Duration: 6 months Treatment group Tablet of silybum marianum, Pueraria lobate and salvia miltiorrhiza Tablet name: tablet of silybum marianum, Pueraria lobate and salvia miltiorrhiza; Dosage: 1g/tablet, 3 tablets/time； Frequency: 2 times/day; Duration: 6 months
- Primary Outcome Measures
Name Time Method Change from baseline liver fibrosis biomarker (collagen type IV) at 6 months 0 and 6 months Liver fibrosis biomarker 4: Collagen type IV
Change from baseline liver fibrosis biomarker (glycocholic acid) at 6 months 0 and 6 months Liver fibrosis biomarker 5: Glycocholic acid
Change from baseline NAFLD fibrosis score at 6 months 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)
Change from baseline liver fibrosis biomarker (hyaluronic acid) at 6 months 0 and 6 months Liver fibrosis biomarker 2: hyaluronic acid
Change from baseline liver fibrosis biomarker (laminin) at 6 months 0 and 6 months Liver fibrosis biomarker 3: laminin
Change from baseline proton density fat fraction of liver at 6 months 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 0 and 6 months Liver fibrosis biomarker 1: Type pro-collagen III N terminal peptide
- Secondary Outcome Measures
Name Time Method Change from baseline liver function biomarker (ALT) at 6 months 0 and 6 months Liver function biomarkers 2: serum ALT
Change from baseline systolic blood pressure at 6 months 0 and 6 months Blood pressure: systolic blood pressure
Change from baseline percentage fat mass at 6 months 0 and 6 months Percentage Fat mass (%FM): %FM (%) at total body and sub-regions determined by DXA
Change from baseline liver function biomarker (ALP) at 6 months 0 and 6 months Liver function biomarkers 5: serum alkaline phosphatase (ALP)
Change from baseline fasting blood lipid (TC) at 6 months 0 and 6 months Fasting blood lipid 2: serum total cholesterol
Change from baseline liver function biomarker (total protein) at 6 months 0 and 6 months Liver function biomarkers 4: serum total protein
Change from baseline fasting blood insulin at 6 months 0 and 6 months Fasting blood insulin: serum insulin
Change from baseline diastolic blood pressure at 6 months 0 and 6 months Blood pressure: diastolic blood pressure
Change from baseline liver function biomarker (AST) at 6 months 0 and 6 months Liver function biomarkers 1: AST
Change from baseline liver function biomarker (GGT) at 6 months 0 and 6 months Liver function biomarkers 3: serum gamma-glutamyl transpeptidase (GGT)
Change from baseline liver function biomarker (bile acids) at 6 months 0 and 6 months Liver function biomarkers 6: serum bile acids
Change from baseline fasting blood lipid (TG) at 6 months 0 and 6 months Fasting blood lipid 1: serum triglycerides
Change from baseline fasting blood lipid (HDL-C) at 6 months 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 0 and 6 months Fasting blood lipid 4: serum low-density lipoprotein cholesterol (LDL-C)
Change from baseline fasting blood glucose at 6 months 0 and 6 months Fasting blood glucose: serum glucose
Change from baseline Inflammatory factor (hsCRP ) at 6 months 0 and 6 months Inflammatory factor 1: serum high sensitivity C reactive protein (hsCRP)
Change from baseline Inflammatory factor (IL-6) at 6 months 0 and 6 months Inflammatory factor 2: serum IL-6
Change from baseline oxidative stress (SOD) at 6 months 0 and 6 months Oxidative stress biomarker 1: serum SOD
Change from baseline oxidative stress (MDA) at 6 months 0 and 6 months Oxidative stress biomarker 2: serum malondialdehyde (MDA)
Change from baseline fat mass at 6 months 0 and 6 months Fat mass (FM): FM (kg) at total body and sub-regions determined by a dual energy x-ray absorptiometry (DXA)
Trial Locations
- Locations (1)
Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China