Hepatic Encephalopathy Clinical Trial
Official title:
Efficacy of Combined Oral L-ornithine-L-aspartate and Oral 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
;
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