Clinical Trial: Efficacy of Combined Oral L-Ornithine-L-Aspartate and Lactulose in Patients With Hepatic Encephalopathy

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Efficacy of Combined Oral L-Ornithine-L-Aspartate and Oral Lactulose in Patients With Hepatic Encephalopathy

Brief 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

Detailed Summary:

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

Sponsor: Mahidol University

Current Primary Outcome: To assess improvement of mental status of the patients [ Time Frame: 7 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: To assess improvement of number connection test, serum ammonia, EEG, asterixis and PSE index of the patients [ Time Frame: 7 days ]

Original Secondary Outcome: Same as current

Information By: Mahidol University

Dates:
Date Received: August 21, 2008
Date Started: September 2008
Date Completion: August 2010
Last Updated: June 25, 2009
Last Verified: December 2008