NCT02183233终止3 期
A Double-blind Randomized, Placebo Controlled Study to Assess the Efficacy and the Safety of Eschscholtzia Californica 1000 mg Per Day in Treating Primary Insomnia During a 28 Day Treatment Duration.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 49
- 主要终点
- Change from baseline in sleep latency
研究概览
简要总结
The aim of this trial was to assess the efficacy and safety of Eschscholtzia Californica (EC) in treating patients having psycho-physiologic insomnia in a double-blind randomised placebo controlled trial during a 28-day treatment duration.
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
- •Male or female above 18 or below 65 years old
- •Diagnosis of psycho-physiologic insomnia, according to the criteria of DSM-IV (Diagnostic and Statistical manual - Version IV)
- •Written informed consent
排除标准
- •Patient who is already taking other investigational drugs or who has taken part in another trial during the past three months
- •Patient who has an history of psychiatric diseases, such as:
- •anxiety disorders; the score of the HAMA (Hamilton anxiety scale) must be < 10
- •depression according to the DSM IV criteria; the score of the HAMD (Hamilton depression scale) must be < 10
- •schizophrenia
- •Patient who has an history of neurologic diseases, such as:
- •Parkinson syndrome
- •crania cerebral trauma post syndrome
- •brain tumor
- •fibromyalgia
- •Patient who has an history of an iatrogenic insomnia, due to drugs like antidepressor, neuroleptic or benzodiazepine, hypnotic
- •Patient with an hypersomnia or a sleep apnea syndrome
- •Patient with any pathology inducing a chronic pain, a pyrosis, a nocturnal pollakiuria, a dyspnea
- •Patient with a Restless Leg Syndrome
- •Patient with severe hepatic or renal insufficiency which judged to be regarded as clinically relevant by the investigator, or any known clinically significant disease which may induce a risk for the patient in participating to the trial
- •Breast feeding or pregnant female, or female with no efficient contraception method
- •Patient with non-stabilised thyroid dysfunction
- •Patient with a known allergy to Eschscholtzia Californica or its compounds
- •Patient with alcohol or drug dependency
- •Patient drinking tea, coffee or Coca-Cola after 4 p.m.
研究组 & 干预措施
Eschscholtzia Californica
Experimental
干预措施: Eschscholtzia Californica (Drug)
Eschscholtzia Californica Placebo
Placebo Comparator
干预措施: Eschscholtzia Californica Placebo (Drug)
结局指标
主要结局
Change from baseline in sleep latency
时间窗: Days 0, 7, 14 and 28
次要结局
- Change from baseline in morning concentration ability(Days 0, 7, 14 and 28)
- Change from baseline in sleep duration(Days 0, 7, 14 and 28)
- Change from baseline in Clinical Global Impression (CGI) score(Days 0, 7, 14 and 28)
- Change from baseline in quality of life (QL questionnaire SF-23)(Days 0, 7, 14 and 28)
- Number of patients with adverse events(up to 28 days)
- Change from baseline in number of awakenings(Days 0, 7, 14 and 28)
- Change from baseline in quality of sleep(Days 0, 7, 14 and 28)
- Change from baseline in presence of morning sleepiness(Days 0, 7, 14 and 28)
研究者
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