Effects of Tablets of Silybum Marianum, Pueraria Lobate and Salvia Miltiorrhiza on Fatty Liver
NCT ID: NCT05076058
Last Updated: 2021-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
118 participants
INTERVENTIONAL
2021-03-01
2022-06-30
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
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
Control group
Tablet name: Placebo;
Dosage: 1g/tablet, 3 tablets/time；
Frequency: 2 times/day;
Duration: 6 months
Placebo tablet
Brand names: BY-HEALTH；
Main contents : starch
Interventions
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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
Placebo tablet
Brand names: BY-HEALTH；
Main contents : starch
Eligibility Criteria
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Inclusion Criteria
* BMI: 24-30 kg/m2
* Fatty liver, assessed by ultrasound or MR
* Had normal diet and normal daily life.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Yu-ming Chen
Professor
Locations
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Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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References
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Li BY, Xi Y, Liu YP, Wang D, Wang C, Chen CG, Fang XH, Li ZX, Chen YM. Effects of Silybum marianum, Pueraria lobate, combined with Salvia miltiorrhiza tablets on non-alcoholic fatty liver disease in adults: A triple-blind, randomized, placebo-controlled clinical trial. Clin Nutr ESPEN. 2024 Oct;63:2-12. doi: 10.1016/j.clnesp.2024.06.003. Epub 2024 Jun 10.
Other Identifiers
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K19-51000-043
Identifier Type: -
Identifier Source: org_study_id