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

Primary Purpose

Nonalcoholic Fatty Liver Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Silibinin extract, mixed power of pueraria, schisandra and salvia miltiorrhiza
Silibinin extract
Placebo
Sponsored by
Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Fatty Liver Disease focused on measuring Nonalcoholic fatty liver disease, Silymarin, Inflammation, Lipid metabolism

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Nutrition, School of Public Health, Guangdong Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Compound silymarin

Silymarin

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Liver enzymes
Serum activities of alanine transaminase (ALT) and aspartate transaminase (AST)
Lipid profile
Serum levels of total cholesterol (TC), triglyceride (TG), high density lipoprotein-cholesterol (HDL-C) and low density lipoprotein-cholesterol (LDL-C)

Secondary Outcome Measures

T-Lymphocytes' composition
Changes of T-Lymphocytes' composition in peripheral blood
Bile acid metabolism
Composition of serum and fecal bile acids

Full Information

First Posted
August 8, 2022
Last Updated
September 12, 2023
Sponsor
Guangzhou Medical University
Collaborators
Affiliated Hospital of Guangdong Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05497765
Brief Title
An Intervention Study of Compound Silymarin in Patients With Non-alcoholic Fatty Liver Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Medical University
Collaborators
Affiliated Hospital of Guangdong Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Fatty Liver Disease
Keywords
Nonalcoholic fatty liver disease, Silymarin, Inflammation, Lipid metabolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
129 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Compound silymarin
Arm Type
Experimental
Arm Description
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
Arm Title
Silymarin
Arm Type
Active Comparator
Arm Description
Dietary supplement: 4 tablets of silymarin twice a day for 12 weeks The active ingredient in each tablet: 81.6 mg of silibinin
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dietary supplement: 4 tablet of placebo twice a day for 12 weeks Placebo Composition: corn dextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
Silibinin extract, mixed power of pueraria, schisandra and salvia miltiorrhiza
Intervention Description
Take 4 tablets with warm water twice a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Silibinin extract
Intervention Description
Take 4 tablets with warm water twice a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Take 4 tablets with warm water twice a day
Primary Outcome Measure Information:
Title
Liver enzymes
Description
Serum activities of alanine transaminase (ALT) and aspartate transaminase (AST)
Time Frame
Change from baseline ALT and AST at 12 weeks
Title
Lipid profile
Description
Serum levels of total cholesterol (TC), triglyceride (TG), high density lipoprotein-cholesterol (HDL-C) and low density lipoprotein-cholesterol (LDL-C)
Time Frame
Change from baseline lipid profile at 12 weeks
Secondary Outcome Measure Information:
Title
T-Lymphocytes' composition
Description
Changes of T-Lymphocytes' composition in peripheral blood
Time Frame
Change from baseline T-Lymphocytes' composition at 12 weeks
Title
Bile acid metabolism
Description
Composition of serum and fecal bile acids
Time Frame
Change from baseline composition of serum and fecal bile acids at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongdui Ruan, MD
Phone
86-769-89190418
Email
13829202566@139.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jindong Ni, PhD
Phone
86-769-22896569
Email
ggwsxy-s.jxx@gdmu.edu.cn
Facility Information:
Facility Name
Department of Nutrition, School of Public Health, Guangdong Medical University
City
Dongguan
State/Province
Guangdong
ZIP/Postal Code
523808
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Honghui Guo, PhD
Phone
86-769-22896576
Email
guohh1999@gdmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Meiqing Mai, MD
Phone
86-769-22896576
Email
maimeqi@gdmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35635048
Citation
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.
Results Reference
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PubMed Identifier
34370218
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.
Results Reference
background
PubMed Identifier
33418491
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.
Results Reference
background
PubMed Identifier
31536511
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.
Results Reference
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PubMed Identifier
29245314
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.
Results Reference
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PubMed Identifier
28419855
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.
Results Reference
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An Intervention Study of Compound Silymarin in Patients With Non-alcoholic Fatty Liver Disease

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