Drug/Chemical Induced Liver Injury. Toxic liver disease
Conditions
Interventions
Intervention 1: Intervention group: In addition to standard care, participants will receive Livergol® (manufactured by Goldaru Pharmaceutical Co.) administered orally at a dosage of 140 mg every 8 hou
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Adult patients aged 18 to 75 years. Confirmed diagnosis of acute drug-induced liver injury (DILI) or chemical-induced hepatotoxicity. A probable or highly probable causal relationship between the suspected drug/chemical and the liver injury, as assessed by a validated scale such as the Roussel Uclaf Causality Assessment Method (RUCAM) with a score = 6. Significant elevation of liver enzymes at the time of screening, defined as at least one of the following: Alanine aminotransferase (ALT) level = 5 times the upper limit of normal (ULN). Aspartate aminotransferase (AST) level = 5 times the upper limit of normal (ULN). A combination of elevated ALT or AST (= 3 × ULN) and elevated total bilirubin (= 2 × ULN) Ability and willingness to provide written informed consent prior to any study-related procedures.
Exclusion criteria
Exclusion criteria: Viral hepatitis Non-alcoholic fatty liver disease Autoimmune hepatitis. Liver cirrhosis Jaundice Known hypersensitivity or allergy to Silybum marianum Pregnancy Breastfeeding Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alanine Aminotransferase Level. Timepoint: At baseline (upon admission, before intervention), and at 48 and 96 hours post-intervention. Method of measurement: Photometric method (enzymatic assay).;Aspartate Aminotransferase Level. Timepoint: At baseline (upon admission, before intervention), and at 48 and 96 hours post-intervention. Method of measurement: Photometric method (enzymatic assay).;Alkaline Phosphatase Level. Timepoint: At baseline (upon admission, before intervention), and at 48 and 96 hours post-intervention. Method of measurement: Photometric method (enzymatic assay). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMitra Rahimi
Shahid Beheshti University of Medical Sciences
Outcome results
None listed