Effects of a Bacopa Monnieri extract (Bacognize) on sleep quality and stress parameters in healthy adults with poor sleep: a randomised, double-blind, placebo-controlled study.

Clinical Research Australia0 个研究点目标入组 100 人开始时间: 2020年7月27日最近更新: 2022年4月4日

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 100

研究概览研究设计入排标准研究者记录与标识符相似试验

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.Adults (male and female) between 18 and 70
•2.Self-reported symptoms of poor sleep lasting greater than 4 weeks (participants will need to give a score of 3 or more on at least one of the first four questions on the BIS and a score of 3 or more on at least one of the last two questions)
•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 Bacopa supplements

研究者

发起方

Clinical Research Australia

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