Therapeutic Efficacy of Oral L-Ornithine-L-Aspartate on Liver Cirrhosis and Minimal Encephalopathy: a Single Center Placebo Control Double Blind Study
试验速览
- 阶段
- 4 期
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Psychometric tests and critical flicker frequency
研究概览
简要总结
The study aimed to assess the effectiveness and safety of L-ornithine-L-aspartate in the management of hepatic encephalopathy.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhosis and diagnosis of minimal hepatic encephalopathy using psychometric tests and critical flicker frequency
排除标准
- •Hepatic encephalopathy grade 1 to 4
- •Use of drugs to treatment of hepatic encephalopathy (lactulose, neomycin)
- •Psychoactive substance use within 72 hours
研究组 & 干预措施
L-ornithine-L-aspartate
5 g L-ornithine-L-aspartate (1 sachet) three times per day for 60 days
干预措施: L-ornithine-L-aspartate (Drug)
placebo
5 g (1 sachet) of placebo comparator three times per day for 60 days
干预措施: placebo (Drug)
结局指标
主要结局
Psychometric tests and critical flicker frequency
时间窗: day 0, 15, 30, 45 and 60
次要结局
- 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)