Double-blind Randomized Trial on the Effect of Olive Oil and Flaxseed Oil on Constipation of Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Score of constipation symptoms
研究概览
简要总结
The purpose of this study was to evaluate the effect of olive oil and flaxseed oil in the treatment of constipation of patients undergoing hemodialysis.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Constipated patients by Rome III criteria
- •Hemodialysis > 3 months
排除标准
- •Diagnosis of gastrointestinal disease other than constipation
- •Previous intolerance to the oils used in the study
- •Cognitive limitations
结局指标
主要结局
Score of constipation symptoms
时间窗: 1 month
Constipation was diagnosed by the Rome III criterion. The diagnosis consists in the presence, for at least three months, of two or more of the following symptoms: "fewer than three evacuations per week", "straining on evacuation", "lumpy or hard stools", "incomplete evacuation", "anorectal obstruction" and use of "manual maneuvers" to facilitate evacuation. Each symptom is scored as: 0=never or rarely, 1=sometimes, 2=often, 3=most of the time and 4=always. In the present study, the frequency of the symptoms was considered as a continuous variable and, a final score ranging from 0 to 24 was calculated. Lowest scores were indicative of fewer symptoms of constipation.
次要结局
未报告次要终点
研究者
Lilian Cuppari
Affiliate Professor
Federal University of São Paulo