ACTRN12619000863134已完成未知
Effects of saffron on sleep quality in healthy adults with self-reported unsatisfactory sleep: a randomised, double-blind, placebo-controlled study
Clinical Research Australia0 个研究点目标入组 63 人开始时间: 2019年6月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 63
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1. Healthy adults (male and female) between 18 and 70
- •2. Self-reported symptoms of unsatisfactory sleep lasting greater than 4 weeks (as measured by a score between 8 and 21 on the Insomnia Sleep Index)
- •3. Medication-free for at least 4 weeks apart from the contraceptive pill and no more than once a week use of pain-relieving medications.
- •4. Non-smoker
- •5. BMI between 20 and 30
- •6. Typical bedtime between 9 p.m. and 12 a.m.
- •7. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
排除标准
- •1. Employed in night shift work or rotational shift work
- •2. Suffer from sleep disorder other than moderate insomnia (e.g, sleep apnoea, restless leg syndrome, periodic limb movement disorder)
- •3. Chronic sleep disturbance greater than 1 year
- •4. Suffer from mental health disorder (other than mild depressive or anxiety symptoms as measured by the Depression, Anxiety and Stress Scale-21)
- •5. Coffee intake greater than 3 cups a day (or equivalent caffeine intake from other caffeinated drinks e.g., tea, energy drinks)
- •6. Alcohol consumption > 14 standard drinks per week
- •7. Experiencing external factors that may affect sleep patterns (e.g., infant/children regularly awakening, excess noise, snoring partner, pain condition)
- •8. Currently receiving non-pharmacological treatment of sleep disorders (e.g., cognitive behavioural therapy, relaxation therapy)
- •9. Current or 12-month history of illicit drug abuse
- •10. Pregnant women, women who are breastfeeding or women who intended to fall pregnant.
- •11. Suffering from medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gastrointestinal disease requiring regular use of medications, gallbladder disease/gallstones/biliary disease, endocrine disease, psychiatric disorder, and neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury), acute or chronic pain affecting sleep
- •12. Current use of supplements that may affect sleep
- •13. Currently taking saffron supplements
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