Covert Hepatic Encephalopathy??
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willingness to provide signed informed consent. 2. Age 18–75 years, regardless of gender 3. Diagnosis of liver cirrhosis confirmed by clinical, laboratory, imaging, and/or liver biopsy 4. Diagnosis of Covert Hepatic Encephalopathy (CHE) by both PHES and Stroop tests, meeting the following criteria: PHES score =187 seconds.
Exclusion criteria
Exclusion criteria: 1. History of alcohol abuse within the last 3 months or inability to discontinue alcohol during the study period (equivalent to ethanol intake >=40g/day for males or >=20g/day for females). 2. Plans to modify the baseline disease treatment regimen within 4 weeks after enrollment (including but not limited to antiviral therapy, etiological treatment, hepatoprotective drugs, probiotics, PPIs, etc.). 3. Current use of rifaximin or lactulose, with treatment duration <1 week. 4. Use of psychotropic drugs within the last 4 weeks. 5. History of gastrointestinal bleeding or infection within the last 4 weeks. 6. Occurrence of overt hepatic encephalopathy within the last 4 weeks. 7. History of portosystemic shunt surgery or TIPS (transjugular intrahepatic portosystemic shunt). 8. Impaired vision, color blindness, or motor dysfunction affecting PHES or Stroop testing. 9. Uncontrolled neuropsychiatric or neurological disorders affecting cognitive function (e.g., Alzheimer’s disease, Parkinson’s disease, schizophrenia). 10. Confirmed or suspected concurrent liver malignancy. 11. HIV infection. 12. Uncontrolled hypertension, diabetes, or other severe cardiopulmonary diseases. 13. White blood cell count <1×10?/L. 14. Pregnant or breastfeeding women, or women with potential pregnancy. 15. Participation in other drug trials within the last 3 months. 16. Other conditions deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reversal rate of CHE; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of HPQOL;psychometric hepatic encephalopathy score, PHES;EncephalaApp Stroop Test;blood ammonia;Biochemical indicators of liver function; | — |
Countries
China
Contacts
Shanghai East Hospital (East Hospital Affiliated to Tongji University)