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The main characteristics and mechanism of liver injury caused by the combination of Chinese and Western drugs

The main characteristics and mechanism of liver injury caused by the combination of Chinese and Western drugs

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2000003728
Enrollment
Unknown
Registered
2020-08-26
Start date
2020-10-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

drug-induced liver injury

Interventions

Sponsors

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Prospective follow-up cohort of liver injury caused by tripterygium wilfordii preparation combined with different Western medicine: (1) patients with rheumatoid arthritis (ra) basic diseases, one of the admission diagnosis of drug-induced liver injury "" or" drug-induced liver disease "or" drug-induced hepatitis "or" drug-induced liver damage "or" drug cirrhosis "or" drug-induced liver failure or use other diagnostic terminology hints may be an various types of drug-induced liver injury patients, diagnostic criteria, meet above drug-induced liver injury and causation RUCAM score of 3 or more cases; (2) No limitation on age and gender; sign informed consent. Clinical study on DILI induced by immunocheckpoint inhibitor combined with Traditional Chinese medicine: (1) basic diseases of liver cancer patients, the hospital diagnosis of drug-induced liver injury "" or" drug-induced liver disease "or" drug-induced hepatitis "or" drug-induced liver damage "or" drug cirrhosis "or" drug-induced liver failure or use other diagnostic terminology hints may be an various types of drug-induced liver injury patients, diagnostic criteria, meet above drug-induced liver injury and causation RUCAM score of 3 or more cases; (2) No limitation on age and gender; sign informed consent.

Exclusion criteria

Exclusion criteria: Prospective follow-up cohort of liver injury caused by tripterygium wilfordii preparation combined with different Western medicine: (1) The possibility of drug-induced liver injury has been clearly excluded at the time of discharge diagnosis of various types of liver injury; (2) Patients with incomplete clinical key data, unable to make clinical judgment on DILI diagnosis or unable to use RUCAM scale for causal assessment; (3) Liver damage caused by exposure to toxic chemicals; (4) Patients with liver injury combined with other factors such as virus, immunity, alcohol, genetic metabolism, bile duct, blood vessel, etc.; (5) Non-rheumatoid arthritis patients. Clinical study on DILI induced by immunocheckpoint inhibitor combined with Traditional Chinese medicine: (1) The possibility of drug-induced liver injury has been clearly excluded at the time of discharge diagnosis of various types of liver injury; (2) Patients with incomplete clinical key data, unable to make clinical judgment on DILI diagnosis or unable to use RUCAM scale for causal assessment; (3) Liver damage caused by exposure to toxic chemicals; (4) Patients with liver injury combined with other factors such as virus, immunity, alcohol, genetic metabolism, bile duct, blood vessel, etc.; (5) Non-liver cancer patients.

Design outcomes

Primary

MeasureTime frame
outcoms related to viral hepatitis A;Renal biochemical;outcoms related to viral hepatitis B;outcoms related to viral hepatitis C;blood routine examination;B-mode ultrasound;autoantibody;routine urine test;ECG;immune globulin;liver biochemical;outcoms related to viral hepatitis E;outcoms related to viral hepatitis D;

Countries

China

Contacts

Public ContactLiu Chenghai

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

chenghailiu@hotmail.com+86 13661406534

Outcome results

None listed

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