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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
35
L-ornithine-L-aspartate 1 sachet(3 grams)3 times a day for 7 days
placebo 3 times a day for 7 days
Siriraj Hospital, Mahidol University
Bangkok, Thailand
To assess improvement of mental status of the patients
Time frame: 7 days
To assess improvement of number connection test, serum ammonia, EEG, asterixis and PSE index of the patients
Time frame: 7 days
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