Drug-Induced Liver Injury
Conditions
Keywords
Drug-Induced, Acute Liver Injury
Brief summary
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.
Detailed description
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.
Interventions
DRUGMagnesium Isoglycyrrhizinate Injection 100mg OD
Magnesium Isoglycyrrhizinate Injection 100mg OD
DRUGMagnesium Isoglycyrrhizinate Injection 200mg OD
Magnesium Isoglycyrrhizinate Injection 200mg OD for 4 weeks
DRUGTiopronin Injection
Tiopronin Injection 200mg OD
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of ALT normalization at week 4 of treatment | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| rates of ALT normalization at weeks 1, 2, and 3 of treatment | 3 weeks |
| change of ALT at weeks 1, 2, 3 and 4 of treatment; | 4 weeks |
| change of AST at weeks 1, 2, 3 and 4 of treatment. | 4 weeks |
Countries
China
Outcome results
None listed