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Impact of Different Treatments on Prognosis in Patients with Drug-Induced Liver Injury: A Prospective Observational Study

Impact of Different Treatments on Prognosis in Patients with Drug-Induced Liver Injury: A Prospective Observational Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123565
Enrollment
Unknown
Registered
2026-04-28
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Drug-induced liver injury, DILI

Interventions

Observation Group:None

Sponsors

Fifth Medical Center, Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with clinical diagnosis who meet the diagnostic criteria or medical records of drug-induced liver injury: "drug-induced liver injury" or "drug-induced liver disease" or "drug-induced hepatitis" or "drug-induced liver injury" or "drug-induced cirrhosis (compensated period)" or other terms diagnosed as drug-induced liver injury; 2. Age range of subjects: >=18 years old; 3. RUCAM score >= 6 points; 4. Patients voluntarily participated and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Age under 18 years; 2. Patients with liver injury not caused by drugs; 3. Current liver biochemical abnormalities caused by other etiologies (e.g., viral hepatitis, alcoholic liver disease, metabolic dysfunction-associated fatty liver disease, autoimmune liver disease, etc.); 4. Severe or life-threatening diseases of the heart, lungs, brain, kidneys, gastrointestinal tract, or systemic conditions; 5. Patients unable to express their chief complaints, such as those with mental disorders; 6. Patients with poor compliance who are unable to cooperate; 7. Pregnant or lactating women; 8. Participation in other clinical trials within the past 3 months; 9. Any other conditions deemed inappropriate for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
Relationship between different treatment regimens and prognosis of DILI;

Secondary

MeasureTime frame
Incidence rate of chronicity in DILI;Rate of severe progression in DILI;Risk factors for chronic course development in DILI;Risk factors for severe progression in DILI;Cost-effectiveness ratio of different treatment regimens in DILI patients;Impact of traditional Chinese medicine constitution classification on chronicity/severe progression in DILI;Effect of different treatment regimens on TCM constitution scores in DILI patients;Relapse rate after recovery from DILI;Changes in clinical laboratory indicators (e.g., ALT, AST);

Countries

China

Contacts

Public ContactLu Yinying

Fifth Medical Center, Chinese PLA General Hospital

meg-forever@163.com+86 133 0125 6799

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026