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Clinical Trial Summary

The study adopted the superiority design of multi center, randomized, double-blind, positive control drug, dose finding, using two simulation skills. The qualified subjects, according to the ratio of 1:1:1, were randomized into low dose group, high dose group and positive drug control group, and received a treatment course of 4-8 weeks, all individuals were followed up for 4 weeks after drug withdrawal.


Clinical Trial Description

Explore the safety and efficacy of different doses of bicyclol in 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, dose finding, positive control drug, superiority test, using two simulation skills. The qualified subjects, according to the ratio of 1:1:1, were randomized into low dose group and high dose group and positive drug control group, and received a treatment course of 4-8 weeks, all individuals were followed up for 4 weeks after drug withdrawal. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02944552
Study type Interventional
Source Drug Induced Liver Disease Study Group
Contact
Status Completed
Phase Phase 2
Start date August 18, 2017
Completion date July 31, 2019

See also
  Status Clinical Trial Phase
Completed NCT03679442 - Macrophage Markers, Soluble CD163 (sCD163) and Soluble CD206 (sCD206) in Paracetamol Overdose Phase 1
Recruiting NCT05711459 - Bicyclol in the Treatment of Antineoplastic Drug-induced Liver Injury. N/A
Recruiting NCT05063500 - The Multi-Center, Randomized, Double-blind, Positive Controlled Clinical Trial of Bicyclol in the Treatment of Acute DILI Phase 3