Clinical Trial: Efficacy and Safety Study of Magnesium Isoglycyrrhizinate Injection in Subjects With Acute Drug-induced Liver Injury
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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
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 Summary: 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.
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Current Primary Outcome: Rate of ALT normalization at week 4 of treatment [ Time Frame: 4 weeks ]
Original Primary Outcome: The improvement of the liver function [ Time Frame: 4 weeks ]
Current Secondary Outcome:
- rates of ALT normalization at weeks 1, 2, and 3 of treatment [ Time Frame: 3 weeks ]
- change of ALT at weeks 1, 2, 3 and 4 of treatment; [ Time Frame: 4 weeks ]
- change of AST at weeks 1, 2, 3 and 4 of treatment. [ Time Frame: 4 weeks ]
Original Secondary Outcome:
- The improvement of the clinical symptoms and signs [ Time Frame: 4 weeks ]Compare the score of the clinical symptoms and signs at the baseline and each following treatment week to evaluate the efficacy
- Changes in ALT [ Time Frame: 4 weeks ]
Information By: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Dates:
Date Received: April 6, 2016
Date Started: December 2007
Date Completion:
Last Updated: September 25, 2016
Last Verified: September 2016