NCT02734966

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Drug-Induced Liver Injury

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-12-01
• Primary completion: 2008-12-01
• Completion: 2011-12-01
• First posted: 2016-04-12
• Last updated: 2016-09-27

Locations

8 sites across 1 country: China