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A multicenter, randomized, double-blind, positive controlled phase iii clinical trial of dicyclol tablets in the treatment of acute drug-induced liver injury -- an extended long-term observational study

A multicenter, randomized, double-blind, positive controlled phase iii clinical trial of dicyclol tablets in the treatment of acute drug-induced liver injury -- an extended long-term observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300072274
Enrollment
Unknown
Registered
2023-06-08
Start date
2023-06-09
Completion date
Unknown
Last updated
2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DILI

Interventions

Treatment Group (Dicyclic alcohol (25mg/ tablet)):N/A
Control Group (Polyene phosphatidylcholine capsule (228mg/ tablet)):N/A

Sponsors

Renji Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Subjects who completed the 4-week follow-up period of the multicenter, randomized, double-blind, positive controlled Phase iii clinical trial of dicyclol tablets in the treatment of acute drug-induced liver injury; The subject can understand and sign the informed consent after fully understanding the nature of the study, the nature of his disease, and the risks that may be borne by participating in the study.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

MeasureTime frame
Outcome evevts, Including complete recovery of liver injury, recurrence of acute liver injury, conversion to chronic liver injury or delayed recovery of liver injury, occurrence of acute liver failure and death;

Secondary

MeasureTime frame
Outcome evevts, Including complete recovery of liver injury, recurrence of acute liver injury, conversion to chronic liver injury or delayed recovery of liver injury, occurrence of acute liver failure and death;the occurrence of liver injury reactivation;The normalization rate of serum ALT;

Countries

China

Contacts

Public ContactYimin Mao

Renji Hospital, SHANGHAI JIAOTONG UNIVERSITY SCHOOL OF MEDICINE

maoym11968@163.com+86 130 0317 5438

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026