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