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临床试验/NCT00740142
NCT00740142已完成4 期

Efficacy of Combined Oral L-ornithine-L-aspartate and Oral Lactulose in Patients With Hepatic Encephalopathy

Mahidol University1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2008年9月最近更新:
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

  1. 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
  1. 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

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

申办方类型
Other
责任方
Sponsor

研究点 (1)

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