ACTRN12620000973910已完成未知
Effects of saffron on sleep quality in adults with unsatisfactory sleep: a randomised, double-blind, placebo-controlled study
Clinical Research Australia0 个研究点目标入组 120 人开始时间: 2020年9月28日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 120
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 poor sleep lasting longer than 4 weeks
- •3. Non-smoker
- •4. BMI between 20 and 35
- •5. Typical bedtime between 9 p.m. and 12 a.m.
- •6. 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 a sleep disorder other than moderate insomnia (e.g, sleep apnoea, restless leg syndrome, periodic limb movement disorder)
- •3. Suffer from mental health disorder other than mild depressive or anxiety symptoms as measured by the Patient Health Questionnaire (PHQ-4)
- •4. Coffee intake greater than 3 cups a day (or equivalent caffeine intake from other caffeinated drinks e.g., tea, energy drinks)
- •5. Alcohol consumption > 14 standard drinks per week
- •6. Experiencing external factors that may affect sleep patterns (e.g., infant/children regularly wakening, excess noise, a snoring partner, pain condition)
- •7. Currently receiving non-pharmacological treatment of sleep disorders (e.g., cognitive behavioural therapy, relaxation therapy)
- •8. Current or 12-month history of illicit drug abuse
- •9. Pregnant women, women who are breastfeeding, or women who intended to fall pregnant.
- •10. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gastrointestinal disease requiring regular use of medications, gallbladder disease/gallstones/biliary disease, autoimmune disease, endocrine disease, acute or chronic pain condition
- •11. Diagnosis of medical or psychiatric conditions including but not limited to: psychiatric disorder (other than mild-to-moderate depression or anxiety), neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury), and cancer/malignancy
- •12. Current use of pharmaceutical medications that may affect sleep quality
- •13. Current use of supplements that may affect sleep
- •14. Currently taking saffron supplements
研究者
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