Overview

Efficacy of Combined Oral L-ornithine-L-aspartate and Lactulose in Patients With Hepatic Encephalopathy

Status:
Completed
Trial end date:
2011-10-01
Target enrollment:
0
Participant gender:
All
Summary
Hypothesis: Is the combination of oral L-ornithine-L-aspartate and lactulose more efficacious than oral lactulose alone in treatment of hepatic encephalopathy? Study design; Randomized, double-blinded, placebo controlled trial
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mahidol University
Treatments:
Lactulose
N-Methylaspartate
Criteria
Inclusion Criteria:

- Cirrhosis

- Age 18-80

- Hepatic encephalopathy grade II-III

- Serum ammonia > 60 mcg/mL

- Informed consent

Exclusion Criteria:

- Recent GI hemorrhage

- Severe sepsis

- Degenerative CNS disease or major psychiatric illness

- Serum creatinine > 1.5 mg/dl

- Pregnancy or lactation

- Poorly controlled DM

- Insertion of TIPS

- Received CNS depressants or hypnotics

- Treatment with metronidazole, kanamycin or branched-chain amino acid

- Hypersensitivity to L-ornithine-L-aspartate