NCT02183714已完成3 期
The Ability of Songha Night ® to Improve Sleep in Patients With Mild to Moderate Sleep Disturbances
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 146
- 主要终点
- Change in sleep quality on a 100 mm visual analogue scale (VAS)
研究概览
简要总结
To evaluate the effect of Songha Night ® on insomnia, anxiety and quality of life compared to placebo in patients with mild to moderate insomnia.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Psychophysiologic insomnia
- •Severity: mild to moderate
- •Duration: subacute to chronic
- •Subjects age > 18 and < 65, men or women
- •Subject had to give written informed consent
排除标准
- •Regular use of psycho-active drugs
- •Work in shifts
- •Use of psychoactive drugs during the past 30 days
- •Any treatment that might interfere with his/her participation in this study and the evaluation of the efficacy or safety of the test drug (e.g. renal insufficiency, hepatic or metabolic dysfunction, cardiovascular disease, psychiatric disorder, myasthenia gravis, delirious state, etc.)
- •known hypersensitivity to any of the ingredients of the study drug
- •Pregnancy, lactation, women of childbearing potential not using an established contraceptive
- •Drug and alcohol abuse
- •Participation in another trial within the past 30 days
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Songha Night ®
Experimental
干预措施: Songha Night ® (Drug)
结局指标
主要结局
Change in sleep quality on a 100 mm visual analogue scale (VAS)
时间窗: baseline, after 2 and 4 weeks of treatment, 1 week after end of treatment
次要结局
- Feeling refreshed score (six point rating scale)(up to week 5)
- Ability to concentrate and perform well score (six point rating scale)(up to week 5)
- Night-time total sleeping time(up to week 5)
- Difficulty in falling asleep (five point rating scale)(up to week 5)
- Number of awakenings during the night(up to week 5)
- Physical and mental health state by short form (SF-36) questionnaire(up to week 5)
- Anxiety by State-Trait Anxiety Inventory(up to week 5)
- Frequency of adverse events(up to week 5)
- Global clinical impression on insomnia by short questionnaire(up to week 5)
研究者
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