Therapeutic Efficacy of Oral L-Ornithine-L-Aspartate on Minimal Encephalopathy

Hospital de Clinicas de Porto Alegre96 enrolled

Overview

The study aimed to assess the effectiveness and safety of L-ornithine-L-aspartate in the management of hepatic encephalopathy.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hepatic Encephalopathy

Interventions

L-ornithine-L-aspartateDRUG

L-ornithine-L-aspartate: 5 g (1 sachet) three times per day for 60 days

placeboDRUG

Placebo: 5 g (1 sachet) three times per day for 60 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Outcomes

Primary Outcomes

Psychometric tests and critical flicker frequency

Time frame: day 0, 15, 30, 45 and 60

Secondary Outcomes

Ammonia concentration

Time frame: time 0 and 60 days after

Health-related quality of life

Time frame: time 0 and 60 days after

Safety analysis

Time frame: time 0 and 60 days after

Data from ClinicalTrials.gov

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