NCT00004796已完成2 期
Phase II Study of Lactulose and Circadian Rhythms in Patients With Cirrhosis
National Center for Research Resources (NCRR)0 个研究点目标入组 16 人开始时间: 1994年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
OBJECTIVES: I. Assess the effect of lactulose on the circadian rhythm of plasma melatonin in patients with subclinical hepatic encephalopathy.
II. Assess the intrasubject variability of circadian melatonin levels and neuropsychological tests.
III. Assess which elements of the neuropsychological test battery show the response to lactulose.
详细描述
PROTOCOL OUTLINE: Patients are alternately assigned to 1 of 2 treatment groups: no therapy for 3 weeks followed by lactulose for 3 weeks versus lactulose for 3 weeks followed by no therapy for 3 weeks.
A dietician advises patients on a 1 g/kg per day protein diet. The lactulose dose is adjusted to result in 2 or 3 loose bowel movements per day.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 0 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Clinical diagnosis of cirrhosis with portal hypertension or portal-systemic shunting
- •-Prior/Concurrent Therapy--
- •No concurrent therapy for hepatic encephalopathy
- •-Patient Characteristics--
- •Age: Under 65
- •Performance status: Not specified
- •Hematopoietic: Not specified
- •Hepatic: See Disease Characteristics
- •Renal: Not specified
- •Other: No alcohol intake within 1 month prior to entry No requirement for beta blockers No requirement for corticosteroids Not in intercontinental travel
排除标准
- 未提供
研究者
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