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

NCT05076058 | Unknown

• 1 other identifier: K19-51000-043
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Fatty Liver Disease

Keywords

fatty liver; silybum marianum; Pueraria lobate; salvia miltiorrhiza

Outcome Measures

Primary Outcomes (7)

• Change from baseline proton density fat fraction of liver at 6 months

  Proton density fat fraction of liver: measured using magnetic resonance (MR)

  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

  0 and 6 months

• Change from baseline liver fibrosis biomarker (hyaluronic acid) at 6 months

  Liver fibrosis biomarker 2: hyaluronic acid

  0 and 6 months

• Change from baseline liver fibrosis biomarker (laminin) at 6 months

  Liver fibrosis biomarker 3: laminin

  0 and 6 months

• Change from baseline liver fibrosis biomarker (collagen type IV) at 6 months

  Liver fibrosis biomarker 4: Collagen type IV

  0 and 6 months

• Change from baseline liver fibrosis biomarker (glycocholic acid) at 6 months

  Liver fibrosis biomarker 5: Glycocholic acid

  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)

  0 and 6 months

Secondary Outcomes (20)

• Change from baseline liver function biomarker (AST) at 6 months

  0 and 6 months

• Change from baseline liver function biomarker (ALT) at 6 months

  0 and 6 months

• Change from baseline liver function biomarker (GGT) at 6 months

  0 and 6 months

• Change from baseline liver function biomarker (total protein) at 6 months

  0 and 6 months

• Change from baseline liver function biomarker (ALP) at 6 months

  0 and 6 months

Other Outcomes (7)

• Change from baseline body weight at 6 months

  0 and 6 months

• Change from baseline body height at 6 months

  0 and 6 months

• Change from baseline waist circumference at 6 months

  0 and 6 months

Study Arms (2)

Treatment group

EXPERIMENTAL

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

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

Control group

PLACEBO COMPARATOR

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

Other: Placebo tablet

Interventions

Tablet of silybum marianum, Pueraria lobate and salvia miltiorrhiza DIETARY_SUPPLEMENT

Brand names: BY-HEALTH； Main contents (per 100g): silibinin 2g, salvianolic acid B 0.72g，Puerarin 0.68g

Treatment group

Placebo tablet OTHER

Brand names: BY-HEALTH； Main contents : starch

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-65 years
• BMI: 24-30 kg/m2
• Fatty liver, assessed by ultrasound or MR
• Had normal diet and normal daily life.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

• 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.

  PMID: 38879879 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Interventions

dan-shen root extract

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo with the same appearance, taste, smell, and packing box to the experimental supplement was used. 118 serial numbers matched to each one participant, and corresponding to study arms (named as 1 or 2 on the tablet box), were used to replace the original label of supplement or placebo after randomization. The code of serial number corresponding to the group code (1 or 2) of tablets was kept by the PI, and will not be disclosed until the completion of all data collection. The group code corresponding to the two types of tablets was/will be kept by the producer till the completion of data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: October 13, 2021
• Study Start: March 1, 2021
• Primary Completion: December 30, 2021
• Study Completion: June 30, 2022
• Last Updated: October 13, 2021

Record last verified: 2021-09

Locations

CN (1)