cirrhosis with hepatic encephalopathy
Conditions
Interventions
Experimental group:Arginine Glutamate Injection
Control group:Ornithine aspartate for injection
Sponsors
Beijing You 'an Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18~75 years old, regardless of gender; 2. Clinically diagnosed as a patient with liver cirrhosis; 3. Clinically diagnosed as HE patients (West-Haven 1-3 patients); 4. Elevated blood ammonia (>60µg/dl); 5. Have not used blood ammonia lowering drugs or treatment within two days before screening; 6. Those who agree to participate in this study and sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with advanced liver cancer (CNLC stage IV patients); 2. Patients with advanced liver failure; 3. Patients with serious diseases of other systems, such as severe endocrine, heart, lung or kidney diseases; 4. People infected with HIV or syphilis; 5. Researchers believe that it may interfere with the subjects treatment or interfere with the subjects compliance, including any uncontrolled clinically significant urinary, circulatory, respiratory, neurological, mental, digestive, endocrine, immune and other system diseases and tumors ; 6. Those who are allergic to any component in arginine glutamate injection or ornithine aspartate for injection; 7. Those who have participated in other clinical studies and used study drugs within 3 months before screening; 8. Two months before the screening or it is estimated that the subjects may use nephrotoxic drugs (such as aminoglycosides, amphotericin B, vancomycin, penteamidine, cisplatin, etc.) or through renal competitive excretion during the study. Secreted drugs (such as probenecid, etc.); 9. Pregnant or breastfeeding women; 10. Those who are taking barbituric acid anesthetics, isoniazid, ion exchange resin or thiazide diuretics; 11. Have a history of drug abuse; 12. Other researchers believe that it is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement rate of patients with hepatic encephalopathy after 7 days of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| the efficiency of Reducing blood ammonia after 7 days treatment;The decrease value and rate of serum ammonia from baseline at 4h, 8h, 24h and 7d after the first administration (time calculated from the beginning of administration, the same as below);Changes from baseline were assessed on the Glasgow Coma Scale at 4h, 8h, 24h, and 7d after first administration;Changes from baseline were assessed by the CNT-A test time scale at 4h, 8h, 24h and 7d after initial administration; | — |
Countries
China
Contacts
Public ContactYu Chen
Outcome results
None listed