Treatment of minimal hepatic encephalopathy with berberine and caffeic acid

Berberine and caffeic acid in the treatment of mild hepatic encephalopathy: a randomized open-labled parallel controlled prospective study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100052806

Enrollment

Unknown

Registered

2021-11-05

Start date

2022-01-01

Completion date

Unknown

Last updated

2023-04-12

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

Conditions

Minimal hepatic encephalopathy

Interventions

Berberine treatment group:Berberine hydrochloride tablets 0.3g oral taken TID(three times a day)

Caffeic acid treatment group:Caffeic acid tablets 0.3g oral taken TID

Control group:General life guidance and treatment of non-hepatic encephalopathy

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. 18-70 years old, male or female with liver cirrhosis; 2. Patients diagnosed with MHE by PHEs and Stroop test; 3. Agree and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to sulfonamides, berberine or caffeic acid; 2. Current or recent (< 3 months) drinking or unable to stop drinking during the study period; 3. Antibiotics used in the past 6 weeks; 4. Lactulose/lactose alcohol, probiotics, L-ornithine-L-aspartic acid, zinc, metronidazole, neomycin or rifaximin were used in the past 6 weeks; 5. Infection or gastrointestinal bleeding in the last 6 weeks; 6. Use of psychoactive drugs in the past 6 weeks; 7. Obvious hepatic encephalopathy occurred in the past 3 months; 8. History of portosystemic shunt or transjugular intrahepatic portosystemic shunt; 9. Poor vision, color blindness or motor defects affect the implementation of psychological tests; 10. Other uncontrollable neurological or mental problems that may affect cognitive function, such as Alzheimer's disease, Parkinson's disease or schizophrenia; 11. Diagnosis or highly suspicious diagnosis of liver malignancy; 12. Human immunodeficiency virus (HIV) infection; 13. uncontrollable hypertension, diabetes or other serious cardio pulmonary diseases; 14. Pregnancy and breastfeeding; 15. Participate in clinical trials of other drugs within 3 months; 16. The researchers believe that it is not suitable for this clinical trial.

Design outcomes

Primary

Measure	Time frame
PHES (Psychometric Hepatic Encephalopathy Score);Stroop test;SIP (Sickness Impact Profile);	—

Secondary

Measure	Time frame
Routine blood test;Liver function;Renal function;Coagulation test;Blood ammonia;Inflammatory cytokines;Urine routine;	—

Countries

China

Contacts

Public ContactChen Yuanwen

Huadong Hospital Affiliated to Fudan University

SHSMUS@263.NET+86 13321885659

Outcome results

None listed

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