Descriptive Study of a Phytotherapy Strategy for Sleep Disorders Related to Anxiety With Phytostandard® Eschscholtzia and Valerian, a Dietary Supplement Based on Eschscholtzia and Valerian Extracts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PiLeJe
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- evolution of the Index of Severity of Insomnia (ISI)
研究概览
简要总结
The aim of the study is to evaluate the effect of a one-month supplementation with Phytostandard® Eschscholtzia and valerian on the Insomnia Severity Index (ISI), in insomniac so-called adjustment subjects (occasional or short-term insomnia)
详细描述
For this study, 40 patients are going to be included. They will have a supplementation of Phytostandard® Eschscholtzia and valerian, from 2 to 4 tablets per day during 28 days.
on the one hand, during the two visits (inclusion and follow-up), the investigator completes the Hamilton Anxiety Scale (HAM-A). During the inclusion visit, he completes with his patient the epworth scale.
on the other hand, patients complete ISI twice : just after the inclusion visit and just before the follow-up visit. He completes two sleep schedules, the first one during the first week of complement and the second one during the fourth.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Suffering from an anxiety resulting in a HAM-A score (Hamilton Anxiety Rating Scale) greater than or equal to 30
- •With a score on Epworth's sleepiness scale strictly greater than 10 (suggestive of a major hypersomnia)
- •Presenting symptoms of sleep apnea syndrome
- •Presenting symptoms of a restless legs syndrome
- •Presenting a chronic pain syndrome requiring the daily intake of analgesic(s)
- •Under psychotropic treatment (neuroleptic, anxiolytic, antidepressant or hypnotic) or under treatment to alter the waking state (antihistamines, beta-blockers, some cough syrups, etc.)
结局指标
主要结局
evolution of the Index of Severity of Insomnia (ISI)
时间窗: day 0 and day 28
This outcome is compared with ISI at day 0 : we compared both the global score and each item scores
次要结局
- Evolution of Hamilton Anxiety Scale (HAM-A)(day 0 and day 28)
- Percentage of Satisfaction(day 28)