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

NCT ID: NCT05497765

Last Updated: 2024-02-28

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2024-02-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Nonalcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Compound silymarin

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

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

Take 4 tablets with warm water twice a day

Silymarin

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

Group Type ACTIVE_COMPARATOR

Silibinin extract

Intervention Type DIETARY_SUPPLEMENT

Take 4 tablets with warm water twice a day

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Take 4 tablets with warm water twice a day

Interventions

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

Take 4 tablets with warm water twice a day

Intervention Type DIETARY_SUPPLEMENT

Silibinin extract

Take 4 tablets with warm water twice a day

Intervention Type DIETARY_SUPPLEMENT

Placebo

Take 4 tablets with warm water twice a day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Hospital of Guangdong Medical University

OTHER

Sponsor Role collaborator

Guangzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Honghui Guo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Dongguan, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 35635048 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34370218 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33418491 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31536511 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29245314 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28419855 (View on PubMed)

Other Identifiers

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GDMUSPH001

Identifier Type: -

Identifier Source: org_study_id

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