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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
244
Patients in the low dose group administrated bicyclol tablet 25mg, one bicyclol blank analog tablet and two polyene phosphatidylcholine blank analog capsules orally, three times daily for 4-8 weeks.
Patients in the high dose group administrated bicyclol tablet 50mg and two polyene phosphatidylcholine blank analog capsules orally, three times daily for 4-8 weeks.
Patients in the positive drug control group administrated polyene phosphatidylcholine capsules 456mg and two bicyclol blank analog tablets orally, three times daily for 4-8 weeks.
Anhui Provincial Hospital
Hefei, Anhui, China
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The decline range of serum ALT after 4 weeks of treatment
The decrease value of serum ALT after 4 weeks of treatment compared to the baseline
Time frame: after 4 weeks of treatment
The decrease value of serum AST compared to the baseline of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks
The decrease value of serum AST compared to the baseline
Time frame: after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks
The decrease value of serum ALT compared to the baseline of treatment for 1, 2, 6, 8 weeks and follow-up for 2, 4 weeks
The decrease value of serum ALT compared to the baseline
Time frame: after 1, 2, 6, 8 weeks treatment and follow-up for 2, 4 weeks
The decrease rate of serum ALT compared to the baseline of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks
The decrease rate of serum ALT compared to the baseline
Time frame: after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks
The time from treatment to ALT normalization
The time from treatment to ALT normalization
Time frame: treatment period
The ratio of subjects whose ALT and AST declined more than 50% compared to the base line of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks
The ratio of subjects whose ALT and AST declined more than 50% compared to the base line
Time frame: after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks
The serum ALT and AST normalization rate of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks
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Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The second affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fuzhou General Hospital of Nanjing Military Command
Fuzhou, Fujian, China
The First affiliated Hospital of Xinxiang Medical University
Weihui, Henan, China
Henan Infectious Diseases Hospital
Zhengzhou, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
...and 7 more locations
The serum ALT and AST normalization rate
Time frame: after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks
The area under curve of ALT and AST of treatment for 1, 2, 4, 6, 8 weeks and follow-up for 2, 4 weeks
The area under curve of ALT and AST
Time frame: after 1, 2, 4, 6, 8 weeks treatment and follow-up for 2, 4 weeks