NCT03337789已完成不适用
Efficacy of Polygonatum Sibiricum on Sleep Quality Improvement
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Chagne from baseline physical activity at 4 weeks assessed by actigraph
研究概览
简要总结
This study aims to investigate the efficacy and safety of Polygonatum sibiricum for sleep quality improvement.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female volunteers who are between the ages of 20 and 65
- •Experienced any of the following sleep problems, at least more than once a week for more than 2 months: 1) difficulty in falling asleep or staying asleep; 2) waking up at dusk and not being able to fall asleep again; 3) not feeling refreshed even after getting some sleep.
排除标准
- •Diagnosed with insomnia assessed with a structured interview and sleep scale measurements
- •Possibility of drug-induced sleep disorders due to current intake of medication (i.e., corticosteroid, statin, etc)
- •Had taken sleeping pills (i.e., zolpidem, benzodiazepine) during the past 2 months
- •Diagnosed with any major medical or neurological disorders assessed during medical history taking, physical examination or experimental tests.
- •Diagnosed with any axis 1 psychiatric disorders (depressive disorder, bipolar disorder, alcohol dependence, schizophrenia) evaluated with a structured instrument
- •A history of traumatic brain injury with loss of consciousness, or any contraindications to MRI (i.e., claustrophobia, metallic foreign devices in body)
- •Had taken psychotropic drugs within the past 3 months before study participation
- •Allergic to polygonatum sibiricum or experienced side effects after consumption of any product containing polygonatum sibiricum
- •Participated in another clinical trial or took other medications during the period that may influence the results of this clinical trial
- •Currently taking contraceptive pills
- •Planning for pregnancy during the period of study participation, currently pregnant or breastfeeding
研究组 & 干预措施
Polygonatum sibiricum
Experimental
干预措施: Polygonatum sibiricum (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Chagne from baseline physical activity at 4 weeks assessed by actigraph
时间窗: Baseline and week 4
Change from baseline objective sleep quality at 4 weeks assessed by polysomnography
时间窗: Baseline and week 4
Change from baseline subjective sleep quality at 4 weeks assessed by Pittsburgh Sleep Quality Index
时间窗: Baseline and week 4
次要结局
- Change from baseline cognitive functions at 4 weeks assessed by the neuropsychological test battery(Baseline and week 4)
- Change from baseline depressive symptom levels at 4 weeks assessed by the Hamilton Depression Rating Scale(Baseline and week 4)
- Change from baseline brain structure, function, and metabolism at 4 weeks assessed by computational analysis of magnetic resonance imaging data(Baseline and week 4)
- Change from baseline anxiety symptom levels at 4 weeks assessed by the Hamilton Anxiety Rating Scale(Baseline and week 4)
研究者
Jieun Kim
Professor
Ewha Womans University
研究点 (2)
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