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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 8
- 主要终点
- Rate of ALT normalization at week 4 of treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
arm 1
lower dose： Magnesium Isoglycyrrhizinate injection 100mg OD for 4 weeks
干预措施: Magnesium Isoglycyrrhizinate Injection 100mg OD (Drug)
arm 2
higher dose：Magnesium Isoglycyrrhizinate injection 200mg OD for 4 weeks.
干预措施: Magnesium Isoglycyrrhizinate Injection 200mg OD (Drug)
Tiopronin Injection
Tiopronin Injection 200mg OD for 4 weeks
干预措施: Tiopronin Injection (Drug)
结局指标
主要结局
Rate of ALT normalization at week 4 of treatment
时间窗: 4 weeks
次要结局
- 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)