NCT00740142已完成4 期
Efficacy of Combined Oral L-ornithine-L-aspartate and Oral Lactulose in Patients With Hepatic Encephalopathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- To assess improvement of mental status of the patients
研究概览
简要总结
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
详细描述
Data collection
- 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
- 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
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhosis
- •Age 18-80
- •Hepatic encephalopathy grade II-III
- •Serum ammonia > 60 mcg/mL
- •Informed consent
排除标准
- •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
研究组 & 干预措施
1
Active Comparator
Interventional arm: oral L-ornithine-L-aspartate and oral lactulose
干预措施: L-ornithine-L-aspartate and lactulose (Drug)
2
Placebo Comparator
Oral lactulose
干预措施: placebo and lactulose (Drug)
结局指标
主要结局
To assess improvement of mental status of the patients
时间窗: 7 days
次要结局
- To assess improvement of number connection test, serum ammonia, EEG, asterixis and PSE index of the patients(7 days)
研究者
研究点 (1)
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