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Efficacy and safety of caffeic acid in improvingmetabolic dysfunction associatedfatty liver disease

Efficacy and safety of caffeic acid in improving hepatic steatosis and metabolic disorders in patients with metabolic dysfunction associatedfatty liver disease

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052729
Enrollment
Unknown
Registered
2021-11-04
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-08-08

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

Conditions

Metabolic dysfunction associated fatty liver disease, MAFLD

Interventions

Treatment group:Lifestyle Guidance + Caffeic Acid Tablets

Sponsors

Huadong Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years; 2. BMI: 23-30 kg/m^2; 3. Pathological diagnosis of liver biopsy or clinical compliance with MAFLD within the past 20 weeks; 4. Undiagnosed diabetes; 5. Agree and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Excessive drinkers (definition: in the past 6 months, the weekly alcohol intake exceeds 140g for men and more than 70g for women); 2. Liver enzymes (ALT or AST) >= 5 times the upper limit of normal; 3. Liver diseases caused by other causes: such as alcoholic liver disease, acute and chronic viral hepatitis, drug-induced, autoimmune liver disease, hereditary liver disease, liver cirrhosis, liver cancer, etc.; 4. Biliary diseases: biliary obstructive diseases, etc.; 5. Other diseases affecting glucose and lipid metabolism: hyperthyroidism, hypothyroidism, hypercortisolism, etc.; 6. Use of drugs that may affect the endpoints of this study within the first three months of enrollment, including pioglitazone, GLP-1 receptor agonists, DDP-4 inhibitors, insulin, and glycyrrhizic acid preparations; 7. Chronic kidney disease or severe renal impairment, defined as serum creatinine greater than 176.8umol/L; 8. The life expectancy is not more than 5 years; 9. Those who are pregnant or plan to become pregnant within the next 1 year; 10. Those who are expected to be unable to complete the intervention follow-up in other circumstances; 11. Continued use of drugs that may affect steatohepatitis for more than 2 weeks (such as cortisol, methotrexate, etc.) within the first three months of enrollment; 12. Participated in other clinical trials within the past 4 weeks; 13. The researcher believes that it is not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
controlled attenuation parameters (CAP);

Secondary

MeasureTime frame
liver function test;fasting blood glucose;blood lipid;insulin;human body index (height, weight, waist circumference);liver stiffness measurement;high-sensitivity C-reactive protein;

Countries

China

Contacts

Public ContactChen Yuanwen

Huadong Hospital Affiliated to Fudan University

shsmus@263.net+86 13321885659

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026