Status:
COMPLETED
Efficacy of Combined Oral L-ornithine-L-aspartate and Lactulose in Patients With Hepatic Encephalopathy
Lead Sponsor:
Mahidol University
Conditions:
Hepatic Encephalopathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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...
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 e...
Eligibility Criteria
Inclusion
- Cirrhosis
- Age 18-80
- Hepatic encephalopathy grade II-III
- Serum ammonia \> 60 mcg/mL
- Informed consent
Exclusion
- Recent GI hemorrhage
- Severe sepsis
- Degenerative CNS disease or major psychiatric illness
- Serum creatinine \> 1.5 mg/dl
- Pregnancy or lactation
- Poorly controlled DM
- Insertion of TIPS
- Received CNS depressants or hypnotics
- Treatment with metronidazole, kanamycin or branched-chain amino acid
- Hypersensitivity to L-ornithine-L-aspartate
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00740142
Start Date
September 1 2008
End Date
October 1 2011
Last Update
September 4 2020
Active Locations (1)
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1
Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700