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

Hepatic Encephalopathy Clinical Trial

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

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00740142
Study type Interventional
Source Mahidol University
Contact
Status Completed
Phase Phase 4
Start date September 2008
Completion date October 2011
View Details
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