An Intervention Study of Compound Silymarin in Patients With Non-alcoholic Fatty Liver Disease
NCT ID: NCT05497765
Last Updated: 2024-02-28
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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COMPLETED
NA
94 participants
INTERVENTIONAL
2022-08-01
2024-02-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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
Silibinin extract, mixed power of pueraria, schisandra and salvia miltiorrhiza
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
Silibinin extract
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
Placebo
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
Silibinin extract
Take 4 tablets with warm water twice a day
Placebo
Take 4 tablets with warm water twice a day
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Affiliated Hospital of Guangdong Medical University
OTHER
Guangzhou Medical University
OTHER
Responsible Party
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Honghui Guo
Professor
Locations
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Department of Nutrition, School of Public Health, Guangdong Medical University
Dongguan, Guangdong, China
Countries
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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.
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.
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.
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.
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.
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.
Other Identifiers
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GDMUSPH001
Identifier Type: -
Identifier Source: org_study_id
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