NCT00740142

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 description

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

Conditions

• Hepatic Encephalopathy

Interventions

Type	Name	Description
DRUG	L-ornithine-L-aspartate and lactulose	L-ornithine-L-aspartate 1 sachet(3 grams)3 times a day for 7 days
DRUG	placebo and lactulose	placebo 3 times a day for 7 days

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-08-01
• Completion: 2011-10-01
• First posted: 2008-08-22
• Last updated: 2020-09-04

Locations

1 site across 1 country: Thailand