Dietary silymarin improves nonalcoholic fatty liver disease via gut microbiota

The effect of silymarin on NAFLD by regulating intestinal flora and its mechanism

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200059043

Enrollment

Unknown

Registered

2022-04-23

Start date

2022-06-30

Completion date

Unknown

Last updated

2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonalcoholic fatty liver disease

Interventions

Group 1:Silymarin

Group 2:Starch control

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Ordinarily resident in Foshan, 18-85 years of age. 2. Subjects were diagnosed of Nonalcoholic fatty liver disease if they satisfied at least one of the following conditions: - Liver’s imaging shows diffuse fatty liver that meet the diagnostic criteria. - Elevated serum ALT and/or AST and/or GGT(ALT>=30 U/L and/or AST>=40U/L and/or GGT >=50U/L) 3.Willing to maintain habitual (regular) diet, less dining out, stable weight in the past three months. 4. Sign the informed consent form and insist on participating in the study.

Exclusion criteria

Exclusion criteria: 1. Alcohol consumption history of patients: equivalent to alcohol intake > 140 g/wk for males and > 70 g/wk for females; 2. Patients with clinically diagnosed viral hepatitis, autoimmune liver disease, cirrhosis, cardiovascular and cerebrovascular diseases and other serious chronic diseases, liver and kidney insufficiency; 3. Alanine aminotransferase (ALT) > 80u/L, aspartate aminotransferase (AST) > 80u/L, Glutathione aminotransferase(GGT) > 100u/L; 4. History of acute or chronic infectious disease, autoimmune disease, cancer, trauma or surgery within 1 month 5. Have taken anti-fatty liver drugs, anti-hepatic fibrosis drugs, lipid-lowering drugs and related health products and phytochemicals within 3 months before the examination. 6. The subjects shall also be excluded if: (1) Severe gastrointestinal disease; (2) Malignant tumor; (3) Pregnant and lactating women.

Design outcomes

Primary

Measure	Time frame
liver imaging detection (Fibroscan);anthropometric parameters;serum aminotransferase levels;	—

Secondary

Measure	Time frame
blood pressure, blood glucose;anti-oxidative and anti-inflammation; gut microbiota ;	—

Countries

China

Contacts

Public ContactLing Wenhua

School of Public Health, Sun Yat-Sen University

lingwh@mail.sysu.edu.cn+86 138 0298 0289

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026