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

Nonalcoholic Fatty Liver Disease Clinical Trial

Official title:

Effects of Compound Silymarin on Biomarkers of Lipid Metabolism and Inflammation in Patients With Non-alcoholic Fatty Liver Disease: A Randomized Controlled Double-blind Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05497765
• Other study ID #: GDMUSPH001
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: February 20, 2024

Study information

• Verified date: February 2024
• Source: Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Non-alcoholic fatty liver disease (NAFLD) has become the most prevalent liver disorder in China but still has no exact therapy for this disease instead of improving our diet and enhancing physical activity. Silymarin is a mixture of flavonoids extracted from seeds of Silybum marianum or milk thistle, and its major active compound is silibinin. Because of its antioxidant, anti-inflammatory and antifibrotic power, silymarin has important biological effects in NAFLD. Furthermore, some traditional liver protective Chinese medicines are also helpful in controlling the progression of NAFLD, such as pueraria, schisandra and salvia miltiorrhiza. At present, there are few reports on the combination of silymarin and these traditional Chinese medicines in the treatment of NAFLD. This study aims to test the effect of compound silymarin on laboratory markers and clinical evolution of patients with NAFLD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: February 20, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• = 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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• Silibinin extract, mixed power of pueraria, schisandra and salvia miltiorrhiza
Take 4 tablets with warm water twice a day
• Silibinin extract
Take 4 tablets with warm water twice a day
• Placebo
Take 4 tablets with warm water twice a day

Locations

Country	Name	City	State
China	Department of Nutrition, School of Public Health, Guangdong Medical University	Dongguan	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Guangzhou Medical University	Affiliated Hospital of Guangdong Medical University

Country where clinical trial is conducted

China, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: PLoS One. 2019 Oct 10;14(10):e0223915. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver enzymes	Serum activities of alanine transaminase (ALT) and aspartate transaminase (AST)	Change from baseline ALT and AST at 12 weeks
Primary	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	T-Lymphocytes' composition	Changes of T-Lymphocytes' composition in peripheral blood	Change from baseline T-Lymphocytes' composition at 12 weeks
Secondary	Bile acid metabolism	Composition of serum and fecal bile acids	Change from baseline composition of serum and fecal bile acids at 12 weeks