Efficacy and Safety Study of Magnesium Isoglycyrrhizinate Injection in Subjects With Acute Drug-induced Liver Injury
NCT02734966 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 174
Last updated 2016-09-27
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.
Conditions
- Drug-Induced Liver Injury
Interventions
- DRUG
-
Magnesium Isoglycyrrhizinate Injection 100mg OD
Magnesium Isoglycyrrhizinate Injection 100mg OD
- DRUG
-
Magnesium Isoglycyrrhizinate Injection 200mg OD
Magnesium Isoglycyrrhizinate Injection 200mg OD for 4 weeks
- DRUG
-
Tiopronin Injection
Tiopronin Injection 200mg OD
Sponsors & Collaborators
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Minde Zeng, MD · RenJi Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-12-31
- Primary Completion
- 2008-12-31
- Completion
- 2011-12-31
Countries
- China
Study Locations
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