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临床试验/ACTRN12621000733875
ACTRN12621000733875尚未招募未知

Investigating the impact of a herbal supplement on sleep in adults with insomnia symptoms

Melrose Health0 个研究点目标入组 40 人开始时间: 2021年6月10日最近更新:
适应症

试验速览

阶段
未知
状态
尚未招募
发起方
入组人数
40

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
22 Years 至 60 Years(—)
性别
All

入选标准

  • Age between 22-60 years.
  • Score between 8 and 14 on the Insomnia Severity Index to define sub-clinical to mild insomnia severity.
  • Meet DSM-V definition of insomnia

排除标准

  • Subjects diagnosed with another sleep disorder (determined by self-report, may include OSA, restless legs syndrome, narcolepsy, etc).
  • Subjects who are using sedatives or hypnotics or anti-depressants and are unwilling or unable to discontinue use during the study.
  • Subjects using hormone therapy or other treatments that may interact with the study treatment.
  • Subjects with major depression or other psychopathology (such as anxiety, bipolar disorder, PTSD, schizophrenia).
  • Subjects who are participating in cognitive behavioural therapy for insomnia (CBT-I) within 4 weeks of Session 1 or who will enter CBT-I during the study period.
  • Subjects with serious illness (e.g. cardiovascular disease, diabetes) that make them unsuitable for the study.
  • Subjects who are allergic to any of the treatment ingredients.
  • Pregnancy, breast-feeding or women intending to become pregnant during the course of the study.
  • Currently taking other over-the-counter medicine for sleep or melatonin in the past month.

研究者

发起方
Melrose Health

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