An Intervention Study of Compound Silymarin in Patients With Non-alcoholic Fatty Liver Disease

NCT05497765 | Completed DMC

• 1 other identifier: GDMUSPH001
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Non-alcoholic fatty liver disease (NAFLD) has become the most prevalent liver disorder in China. The aim of this project is to evaluate the effects of compound silymarin on biomarkers of lipid metabolism and inflammation in the patients with NAFLD.

Conditions

Nonalcoholic Fatty Liver Disease

Keywords

Nonalcoholic fatty liver disease; Silymarin; Inflammation; Lipid metabolism

Outcome Measures

Primary Outcomes (2)

• Liver enzymes

  Serum activities of alanine transaminase (ALT) and aspartate transaminase (AST)

  Change from baseline ALT and AST at 12 weeks

• Lipid profile

  Serum levels of total cholesterol (TC), triglyceride (TG), high density lipoprotein-cholesterol (HDL-C) and low density lipoprotein-cholesterol (LDL-C)

  Change from baseline lipid profile at 12 weeks

Secondary Outcomes (2)

• T-Lymphocytes' composition

  Change from baseline T-Lymphocytes' composition at 12 weeks

• Bile acid metabolism

  Change from baseline composition of serum and fecal bile acids at 12 weeks

Study Arms (3)

Compound silymarin

EXPERIMENTAL

Dietary supplement: 4 tablets of compound silymarin twice a day for 12 weeks The active ingredient in each tablet: 81.6 mg of silibinin, mixed power of pueraria, schisandra and salvia miltiorrhiza

Dietary Supplement: Silibinin extract, mixed power of pueraria, schisandra and salvia miltiorrhiza

Silymarin

ACTIVE COMPARATOR

Dietary supplement: 4 tablets of silymarin twice a day for 12 weeks The active ingredient in each tablet: 81.6 mg of silibinin

Dietary Supplement: Silibinin extract

Placebo

PLACEBO COMPARATOR

Dietary supplement: 4 tablet of placebo twice a day for 12 weeks Placebo Composition: corn dextrin

Dietary Supplement: Placebo

Interventions

Silibinin extract, mixed power of pueraria, schisandra and salvia miltiorrhiza DIETARY_SUPPLEMENT

Take 4 tablets with warm water twice a day

Compound silymarin

Silibinin extract DIETARY_SUPPLEMENT

Take 4 tablets with warm water twice a day

Silymarin

Placebo DIETARY_SUPPLEMENT

Take 4 tablets with warm water twice a day

Placebo

Eligibility Criteria

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

You may qualify if:

• Subject's BMI is ≥ 22.0 kg/m2 and \< 33.0 kg/m2;
• Subject is diagnosed with NAFLD according to the Chinese Non-alcoholic fatty liver disease prevention guide 2018;
• A mildly elevated of ALT level (≥ 30 U/L for male, ≥ 19 U/L for female) or an AST/ALT ratio \< 1.0;
• Must be able to swallow tablets.

You may not qualify if:

• ≥ 30 grams of alcohol/day for male and ≥ 20 grams of alcohol/day for female;
• Patients with certain hepatic diseases such as gallstones, hepatitis C, autoimmune hepatitis, and hepatolenticular degeneration which can lead to fatty liver disease;
• Be taking medicines or supplements that would influence the liver function, lipid metabolism;
• Patients with total parenteral nutrition, inflammatory bowel disease, celiac disease, hypothyroidism, Cushing syndrome, Mauriac syndrome, etc;
• Patients with hereditary diseases, coronary heart disease, mental disorder, cancer, cirrhosis and renal disease;
• Body weight change are more than 10% in previous 3 months;
• Patients who have participated in or are participating in other clinical trials within 3 months of their first administration of the study product;
• Subjects are allergic to the ingredients in the test or control samples;
• Woman who is pregnant or breastfeeding;
• Subjects cannot meet the requirements of compliance in the pre-experiment period;
• Subjects who fail to sign the informed consent forms.

Sponsors & Collaborators

• Guangzhou Medical University: lead
• Affiliated Hospital of Guangdong Medical University: collaborator

Study Sites (1)

Department of Nutrition, School of Public Health, Guangdong Medical University

Dongguan, Guangdong, 523808, China

Location

Related Publications (6)

• Aghemo A, Alekseeva OP, Angelico F, Bakulin IG, Bakulina NV, Bordin D, Bueverov AO, Drapkina OM, Gillessen A, Kagarmanova EM, Korochanskaya NV, Kucheryavii UA, Lazebnik LB, Livzan MA, Maev IV, Martynov AI, Osipenko MF, Sas EI, Starodubova A, Uspensky YP, Vinnitskaya EV, Yakovenko EP, Yakovlev AA. Role of silymarin as antioxidant in clinical management of chronic liver diseases: a narrative review. Ann Med. 2022 Dec;54(1):1548-1560. doi: 10.1080/07853890.2022.2069854.

  PMID: 35635048 BACKGROUND

• Malik A, Nadeem M, Malik MI. Efficacy of elafibranor in patients with liver abnormalities especially non-alcoholic steatohepatitis: a systematic review and meta-analysis. Clin J Gastroenterol. 2021 Dec;14(6):1579-1586. doi: 10.1007/s12328-021-01491-7. Epub 2021 Aug 9.

  PMID: 34370218 BACKGROUND

• Kalopitas G, Antza C, Doundoulakis I, Siargkas A, Kouroumalis E, Germanidis G, Samara M, Chourdakis M. Impact of Silymarin in individuals with nonalcoholic fatty liver disease: A systematic review and meta-analysis. Nutrition. 2021 Mar;83:111092. doi: 10.1016/j.nut.2020.111092. Epub 2020 Nov 25.

  PMID: 33418491 BACKGROUND

• Navarro VJ, Belle SH, D'Amato M, Adfhal N, Brunt EM, Fried MW, Reddy KR, Wahed AS, Harrison S; Silymarin in NASH and C Hepatitis (SyNCH) Study Group. Silymarin in non-cirrhotics with non-alcoholic steatohepatitis: A randomized, double-blind, placebo controlled trial. PLoS One. 2019 Sep 19;14(9):e0221683. doi: 10.1371/journal.pone.0221683. eCollection 2019.

  PMID: 31536511 BACKGROUND

• Zhong S, Fan Y, Yan Q, Fan X, Wu B, Han Y, Zhang Y, Chen Y, Zhang H, Niu J. The therapeutic effect of silymarin in the treatment of nonalcoholic fatty disease: A meta-analysis (PRISMA) of randomized control trials. Medicine (Baltimore). 2017 Dec;96(49):e9061. doi: 10.1097/MD.0000000000009061.

  PMID: 29245314 BACKGROUND

• Wah Kheong C, Nik Mustapha NR, Mahadeva S. A Randomized Trial of Silymarin for the Treatment of Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2017 Dec;15(12):1940-1949.e8. doi: 10.1016/j.cgh.2017.04.016. Epub 2017 Apr 15.

  PMID: 28419855 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Inflammation

Interventions

Silybin; schizandrin; dan-shen root extract

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Silymarin; Flavonolignans; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 11, 2022
• Study Start: August 1, 2022
• Primary Completion: January 31, 2024
• Study Completion: February 20, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)