Drug-induced liver injury
Conditions
Interventions
Trial group:Kuhuang Granules: Dosage and administration: 1 packet per time, 3 times daily.
Control group:S-Adenosylmethionine Disulfate Tosylate Enteric-Coated Tablets: Dosage and administration: 1000 mg once daily.
Sponsors
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.18-80 years old, regardless of gender; 2. Those who meet one of the following conditions: (1) Drug induced liver injury causality score (RUCAM)>8 points; (2) When the Drug induced liver injury causality score (RUCAM) is greater than 6 and less than or equal to 8 points, two or more researchers must simultaneously diagnose and identify the patient as a drug-induced liver injury patient; 3. There are biochemical abnormalities in the liver blood, such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) >= 1 times the upper limit of normal (ULN), or 1 ULN <= total bilirubin (TBIL) level <= 20 ULN; 4. Understand the entire process of the experiment, voluntarily participate and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Known autoimmune system diseases and/or familial genetic diseases and/or difficult and complicated diseases (such as systemic lupus erythematosus, rheumatoid arthritis, psoriasis, type I diabetes, Gilbert syndrome, Cragler Najjar syndrome, Dubin Johnson syndrome, Rotor syndrome, hereditary spherocytosis, thalassemia, paroxysmal nocturnal hemoglobinuria, acquired hemolytic anemia, etc.); 2. There are serious primary diseases of the heart, brain, hematopoietic system, and nervous system; 3. Patients with severe liver and kidney dysfunction, such as blood creatinine>1 times the upper limit of normal (ULN), serum total bilirubin >= 20 times the upper limit of normal (ULN), albumin<35g/L, accompanied by severe complications such as ascites, esophageal and gastric variceal bleeding, and hepatic encephalopathy; 4. Patients who are allergic to known components of the experimental drug or have an allergic constitution, as well as those who cannot receive treatment under this protocol; 5. Pregnant or preparing pregnant women, breastfeeding women; 6. There are other causes of liver injury besides medication; 7. The researcher believes that the participant is not suitable to participate in this study due to any other circumstances or conditions, or factors that affect the participant's safety, or family or social factors that affect the collection of experimental data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recovery rate of liver function after 2 weeks and 4 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with a 50% reduction in liver function from baseline after 2 weeks and 4 weeks of treatment.;Blood coagulation function assessment;Assessment of blood lipid levels;Safety assessment (including incidence of adverse events; complete blood count; two renal function indicators: blood urea nitrogen and creatinine).; | — |
Countries
China
Contacts
Public ContactLi Ying
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed