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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 174
- Locations
- 8
- Primary Endpoint
- Rate of ALT normalization at week 4 of treatment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
arm 1
lower dose： Magnesium Isoglycyrrhizinate injection 100mg OD for 4 weeks
Intervention: Magnesium Isoglycyrrhizinate Injection 100mg OD (Drug)
arm 2
higher dose：Magnesium Isoglycyrrhizinate injection 200mg OD for 4 weeks.
Intervention: Magnesium Isoglycyrrhizinate Injection 200mg OD (Drug)
Tiopronin Injection
Tiopronin Injection 200mg OD for 4 weeks
Intervention: Tiopronin Injection (Drug)
Outcomes
Primary Outcomes
Rate of ALT normalization at week 4 of treatment
Time Frame: 4 weeks
Secondary Outcomes
- 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)