drugset / Trial / NCT05063500
The Multi-Center, Randomized, Double-blind, Positive Controlled Clinical Trial of Bicyclol in the Treatment of Acute DILI
Phase 3
Unknown
360 enrolled
Drug Induced Liver Disease Study Group
Beijing Union Pharmaceutical Factory Ltd · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2021-12-20
- Primary completion
- 2023-05
- Completion
- 2023-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Polyene Phosphatidylcholine | Small molecule | 456 mg | Oral |
| Subject | bicyclol | Small molecule | 50 mg | Oral |