Efficacy and Safety Study of Magnesium Isoglycyrrhizinate Injection in Subjects With Acute Drug-induced Liver Injury

A Multi-center, Randomized, Double-blind, Active Control Phase II Study to Investigate Multiple Dosage and Treatments of Magnesium Isoglycyrrhizinate Injection to Cure the Acute Drug-induced Liver Injury

The purpose of this study is to investigate the safety, effective dosage and treatment of Magnesium Isolycyrrhizinate Injection to cure the acute drug-induced liver injury compared with the Tiopronin Injection.

The pharmacology research shows that Magnesium Isoglycyrrhizinate could significantly decrease the elevation of ALT and AST coursed by carbon tetrachloride, D-galactosamine and Thioacetamide. It could also significantly reduce the injury on the liver coursed by D-galacosamine and immunologic factors. Magnesium Isoglycyrrhizinate with strong anti-inflammatory effect could protect the liver cell and improve the liver function.

Inclusion Criteria:

• RACUM ≥6
• ALTs ≥2ULN, but TBiL is ≤ 3 ULN.It may be associated with AST or ALP or TBiL exceed the upper limit of normal
• Liver biochemical abnormalities duration of no more than three months
• Patients need to fully understand and sign the inform consent form.

Exclusion Criteria:

• The liver injury is caused by other diseases, such as virus hepatitis, alcohol and non-alcohol fatty liver disease or the autoimmune liver disease.
• The patients with the acute hepatic failure or hepatic decompensation, such as hepatic encephalopathy, ascites, albumin is ≤ 35g/L, prothrombin time is elongated more than 2 seconds compared to its normal range.
• The value of the TBiL is > 3ULN.
• The value of serum creatinine is > 1.5ULN.
• Patients who have severe organic diseases on heart, lungs, brain, kidney and gastrointestinal tract.
• Patients who are taking the drugs that might interfere the trial.
• Patients who are allergic or intolerant to the study drug.
• Patients who are not able to express the chief complaint, for example, the patients with psychosis and severe neurosis.
• Patients who are compliant with protocol.
• Women who are pregnant, breast-feeding or with childbearing potential.
• Patients who have attended other clinical trials within 3 months.
• Not appropriate to be included after assessing by the investigators.

ULN=Upper Limited Normal