Drug-Induced Acute Liver Injury Clinical Trial
Official title:
The Multi Center, Randomized, Double-blind, Positive Controlled Phase II Clinical Trial of Bicyclol Tablets in the Treatment of Acute Drug-induced Liver Injury
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.
Explore the safety and efficacy of different doses of bicyclol in 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, dose finding,
positive control drug, superiority test, using two simulation skills. The qualified subjects,
according to the ratio of 1:1:1, were randomized into low dose group and 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.
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