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 ]

Compare the liver function test results at the baseline and each following treatment week to evaluate the efficacy


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