Efficacy and Safety of Magnesium Isoglycyrrhizinate Injection in Subjects With Acute Drug-induced Liver Injury: A multi-center, randomized, double-blind, positive control, phase III clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800016669

Enrollment

Unknown

Registered

2018-06-15

Start date

2009-12-01

Completion date

Unknown

Last updated

2018-06-18

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

intervention group:Magnesium Isoglycyrrhizinate Injection

control group:tiopronin injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years; 2. RACUM =6; 3. ALTs =2ULN, but TBiL = 3 ULN; 4. Liver biochemical abnormalities duration of no more than three months; 5. Patients need to fully understand and sign the inform consent form.

Exclusion criteria

Exclusion criteria: 1. The liver injury is caused by other diseases, such as virus hepatitis, alcohol and non-alcohol fatty liver disease or the autoimmune liver disease; 2. The patients with the acute hepatic failure or hepatic decompensation, such as hepatic encephalopathy, ascites, albumin is = 35g/L, prothrombin time is elongated more than 2 seconds compared to its normal range; 3. The value of the TBiL is > 3ULN; 4. The value of serum creatinine > 1.5ULN; 5. Patients who have severe organic diseases on heart, lungs, brain, kidney and gastrointestinal tract; 6. Patients who are taking the drugs that might interfere the trial; 7. Patients who are allergic or intolerant to the study drug; 8. Patients who are not able to express the chief complaint, for example, the patients with psychosis and severe neurosis; 9. Patients who are compliant with protocol; 10. Women who are pregnant, breast-feeding or with childbearing potential; 11. Patients who have attended other clinical trials within 3 months; 12. Not appropriate to be included after assessing by the investigators.

Design outcomes

Primary

Measure	Time frame
level of glutamic-pyruvic transaminase;level of glutamic oxalacetic transaminase;level of total bilirubin;level of alkline phosphatase;	—

Countries

China

Contacts

Public ContactMinde Zeng

National Pharmaceutical Clinical Research Institute, Renji Hospital Affiliated to Medical School of Shanghai Jiaotong University

694466576@qq.com+86 021-63364118

Outcome results

None listed

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