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

NCT05063500 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2022-08-04

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Beijing Union Pharmaceutical Factory Ltd

    collaborator INDUSTRY

  • Drug Induced Liver Disease Study Group

    lead OTHER

Principal Investigators

  • Yimin Mao · RenJi Hospital

  • Chengwei Chen · 905th Hospital of Pla Navy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-20
Primary Completion
2023-05-31
Completion
2023-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05063500 on ClinicalTrials.gov