NCT05063500View on ClinicalTrials.gov

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

PHASE3UnknownINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

December 20, 2021

Primary Completion Date

May 31, 2023

Study Completion Date

June 30, 2023

Conditions
Drug-Induced Acute Liver Injury
Interventions
DRUG

bicyclol, 25mg/ tablet

Experimental group: each oral bicyclol 50mg, three times daily for 4 weeks.

DRUG

polyene phosphatidylcholine capsules, 228mg/ particle.

Control group: each oral polyene phosphatidylcholine 456mg, three times daily for 4 weeks.

Trial Locations (2)

200127

RECRUITING

Renji Hospital ，Shanghai Jiao Tong University School of Medicine, Shanghai

Unknown

NOT_YET_RECRUITING

905th Hospital of Pla Navy, Shanghai

Sponsors
All Listed Sponsors
collaborator

Beijing Union Pharmaceutical Factory Ltd

INDUSTRY

lead

Drug Induced Liver Disease Study Group

OTHER