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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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05063500
Study type Interventional
Source Drug Induced Liver Disease Study Group
Contact Yimin Mao
Phone 13003175438
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date October 2021
Completion date June 2023

See also
  Status Clinical Trial Phase
Completed NCT03679442 - Macrophage Markers, Soluble CD163 (sCD163) and Soluble CD206 (sCD206) in Paracetamol Overdose Phase 1
Completed NCT02944552 - The Multi Center, Randomized, Double-blind, Positive Controlled Study of Bicyclol in the Treatment of Acute DILI Phase 2