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NCT05497765Completed

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

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

Source: ClinicalTrials.gov · Last updated 28 Feb 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
94 (actual)
First submitted
8 Aug 2022
Start date
1 Aug 2022
Primary completion date
31 Jan 2024
Lead sponsor
Guangzhou Medical University
NCT number
NCT05497765

What you commit to

  • Study type: Interventional
  • Participants enrolled: 94
  • From 1 Aug 2022 to the primary completion date, 31 Jan 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Body weight change are more than 10% in previous 3 months;

Other illness

  • Patients with certain hepatic diseases such as gallstones, hepatitis C, autoimmune hepatitis, and hepatolenticular degeneration which can lead to fatty liver disease;
  • 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;
  • Subjects are allergic to the ingredients in the test or control samples;

Other

  • ≥ 30 grams of alcohol/day for male and ≥ 20 grams of alcohol/day for female;
  • Be taking medicines or supplements that would influence the liver function, lipid metabolism;
  • Patients who have participated in or are participating in other clinical trials within 3 months of their first administration of the study product;
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Nutrition, School of Public Health, Guangdong Medical University
Coordinator of this site? Confirm its status
DongguanChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.