The Multi-Center, Randomized, Double-blind, Positive Controlled Clinical Trial of Bicyclol in the Treatment of Acute DILI

Drug-Induced Acute Liver Injury Clinical Trial

Official title: A Multi-center, Randomized, Double-blind, Positive-controlled Phase Ⅲ Clinical Trial of Bicyclol Tablets in the Treatment of Acute Drug-induced Liver Injury

Status Recruiting

Clinical Trial Summary

The study adopted the design of multi-center, randomized, double-blind, positive control drug, superiority test, using the double-blind double-simulating skills. The qualified subjects, according to the ratio of 1:1, were randomized into experimental group and positive drug control group and received a treatment course of 4 weeks, all individuals were followed up for 4 weeks after drug withdrawal.

Clinical Trial Description

Further evaluated the safety and efficacy of bicyclol in the treatment of acute drug-induced liver injury using polyene phosphatidylcholine capsule as the positive control drug. The study adopted the design of multi-center, randomized, double-blind, positive control drug, superiority test, using the double-blind double-simulating skills. The qualified subjects, according to the ratio of 1:1, were randomized into experimental group and positive drug control group and received a treatment course of 4 weeks, all individuals were followed up for 4 weeks after drug withdrawal. ;

Related Conditions & MeSH terms

• Chemical and Drug Induced Liver Injury
• Drug-Induced Acute Liver Injury

• NCT number: NCT05063500
• Study type: Interventional
• Source: Drug Induced Liver Disease Study Group
• Contact: Yimin Mao
• Phone: 13003175438
• Email: maoym11968@163.com
• Status: Recruiting
• Phase: Phase 3
• Start date: December 20, 2021
• Completion date: June 2023