Drug-induced liver injury
Conditions
Interventions
Silybin Capsules Group:Dministration of silybin capsules, 2 capsules each time, three times a day.
Polyene Phosphatidylcholine Group:Oral administration of polyene phosphatidylcholine, 2 capsules each time, three times a day.
Sponsors
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Meeting the diagnostic criteria for depression in Western medicine; 2.Being treated with agomelatine; 3.Showing abnormally elevated alanine aminotransferase (ALT), a liver function enzyme index; 4.Aged 18–65 years, regardless of gender; 5.Patients who have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Complicated with other chronic liver diseases, including viral hepatitis, metabolic liver disease, alcoholic liver disease, drug-induced liver injury, malignant liver tumor, autoimmune liver disease, etc. 2.Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 3 times the upper limit of normal (ULN); Gamma-Glutamyl Transferase (GGT), Alkaline Phosphatase (ALP), or Total Bilirubin (TBiL) > upper limit of normal (ULN). 3.Pregnant or lactating women; women of childbearing age who do not use effective contraceptive methods (e.g., condoms, hormonal contraceptives, intrauterine devices); or male subjects who are unwilling to adopt contraceptive measures. 4.Patients with severe primary cardiovascular, renal, hematological, pulmonary diseases, tumors, acquired immunodeficiency syndrome (AIDS), or other life-threatening severe illnesses. 5.Patients with a suspected or confirmed history of alcohol or drug abuse. 6.Patients with a known allergy to any component of the study drugs. 7.Patients who have participated in other clinical trials within 3 months prior to the current study. 8.Patients who are considered inappropriate to participate in the study by the investigator(s). 9.Patients with severe suicidal ideation. 10.Patients with mental disorders caused by organic diseases, such as depression induced by hypothyroidism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative incidence of drug-induced liver injury;Liver function; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fibroscan;Ferritin;Inflammatory indicators; | — |
Countries
China
Contacts
Public ContactWang Liqiong
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed