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

 1. Baseline characteristics

 -  demographic data; age, gender, BW, height

 -  cirrhosis; cause, duration, Child-Pugh score,complications of cirrhosis such as EV,
 ascites, hepatic encephalopathy, SBP etc.

 -  comorbidity such as DM, CVA

 2. After randomization

 -  assessment of mental status (West-Haven criteria), Portal-systemic encephalopathy
 index (PSEI), number connection test, serum ammonia, asterixis at Day 1,3,7 and EEG
 at day 1,7

 -  blood chemistry such as CBC, BUN, Creatinine, electrolyte, LFT, coagulogram, BS at
 Day 1,3,7

 -  record adverse effect of drug such as nausea, vomiting, bloating.

 -  record diet, frequency of bowel movement and stool pH

 -  compliance
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