NCT01401946已完成4 期
Soy Isoflavone Tablets: Effects on Questionnaire and Actigraphic Measures of Sleep, Symptoms as Measured by the Women's Health Questionnaire and Cognitive Function as Measured by Computerized Cognitive Performance Tests in Menopausal Women
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
- 88
- 试验地点
- 1
- 主要终点
- Soy Isoflavone Tablets: Effects on Sleep, Quality of Life, Symptoms and Cognitive Function in Menopausal Women
研究概览
简要总结
The study was done to elucidate relationships between midlife women's self-reported hot flashes, neuropsychological symptoms, cognitive performance or sleep.
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
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Body mass index (BMI) more than 34 kg/m2
- •Hypertension
- •Shift work
- •Psychiatric or medical conditions that would affect outcome measures
- •More than 4 caffeine drinks per day
- •More than 10 cigarettes per day
- •More than than 7 alcohol drinks per week
研究组 & 干预措施
soy isoflavones
Active Comparator
干预措施: soy isoflavones (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Soy Isoflavone Tablets: Effects on Sleep, Quality of Life, Symptoms and Cognitive Function in Menopausal Women
时间窗: 9 weeks
Cognitive function measured by computerized cognitive performance tests of motor speed, switching attention, continuous performance and Stroop color-word tests.
Soy Isoflavone: Effects on Sleep, Symptoms, Quality of Life and Cognitive Function in Menopausal Women
时间窗: 9 weeks
Symptoms recorded on the Women's Health Questionniare at baseline and 4 subsequent occasions
次要结局
未报告次要终点
研究者
研究点 (1)
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