Therapeutic Efficacy of Oral L-Ornithine-L-Aspartate on Minimal Encephalopathy
- Registration Number
- NCT00896831
- Lead Sponsor
- Hospital de Clinicas de Porto Alegre
- Brief Summary
The study aimed to assess the effectiveness and safety of L-ornithine-L-aspartate in the management of hepatic encephalopathy.
- Detailed Description
Hepatic encephalopathy continues to be a major clinical problem in cirrhosis. Patients with minimal hepatic encephalopathy are at risk for accidents, had a decline in work performance, or complain of cognitive symptoms, with poor health-related quality of life. This study will compare L-ornithine-L-aspartate with placebo for 60 days to assess the effectiveness, safety and health-related quality of life of this drug.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 96
Inclusion Criteria
- Cirrhosis and diagnosis of minimal hepatic encephalopathy using psychometric tests and critical flicker frequency
Exclusion Criteria
- Hepatic encephalopathy grade 1 to 4
- Use of drugs to treatment of hepatic encephalopathy (lactulose, neomycin)
- Psychoactive substance use within 72 hours
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description L-ornithine-L-aspartate L-ornithine-L-aspartate 5 g L-ornithine-L-aspartate (1 sachet) three times per day for 60 days placebo placebo 5 g (1 sachet) of placebo comparator three times per day for 60 days
- Primary Outcome Measures
Name Time Method Psychometric tests and critical flicker frequency day 0, 15, 30, 45 and 60
- Secondary Outcome Measures
Name Time Method Ammonia concentration time 0 and 60 days after Health-related quality of life time 0 and 60 days after Safety analysis time 0 and 60 days after
Trial Locations
- Locations (1)
Hospital de Clínicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande do Sul, Brazil