Glucocorticosteroid Therapy on Drug-induced Liver Injury: a Prospective Non-randomized Concurrent Control Trial
NCT ID: NCT04553003
Last Updated: 2022-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
80 participants
INTERVENTIONAL
2020-08-01
2025-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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glucocorticoid+hepatoprotectant group
glucocorticoid 0.4mg/kg/d+hepatoprotectant for 7d
Glucocorticoids+hepatoprotectant
Participants received glucocorticoids (0.4mg/kg/d po.) and hepatoprotectant for 7 days.
hepatoprotectant group
hepatoprotectant for 7d
hepatoprotectant
Participants received hepatoprotectants (i.v.gtt.) for 7 days.
Interventions
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Glucocorticoids+hepatoprotectant
Participants received glucocorticoids (0.4mg/kg/d po.) and hepatoprotectant for 7 days.
hepatoprotectant
Participants received hepatoprotectants (i.v.gtt.) for 7 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. RUCAM score≥6 and with liver histology
3. Meet any of the following conditions:
1. TBIL ≥ 10 fold ULN ;
2. TBIL ≥ 5 fold ULN and serum AST or ALT ≥ 20 fold ULN
Exclusion Criteria
2. Other liver diseases, such as autoimmune liver diseases, viral hepatitis, etc
3. with contraindications of glucocorticoid
18 Years
70 Years
ALL
No
Sponsors
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Li Yang
OTHER
Responsible Party
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Li Yang
professor
Locations
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Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University
Chengdu, Sichuan, China
Countries
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Facility Contacts
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Other Identifiers
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LYang
Identifier Type: -
Identifier Source: org_study_id
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