Overview

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

Status:
Completed
Trial end date:
2019-07-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Drug Induced Liver Disease Study Group
Collaborator:
Beijing Union Pharmaceutical Factory
Treatments:
Polyene phosphatidylcholine