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临床试验/NCT05518019
NCT05518019已完成不适用

An Exploratory Investigation of a CBD Supplement's Impact on Sleep, Stress, and Focus

Prima CBD2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
2
主要终点
Change in mood as measured by questionnaire

研究概览

简要总结

A high-quality broad-spectrum cannabidiol supplement with a bio-terpene complex will be administered once daily. It is hypothesized that this supplement will lead to improvements in sleep, focus, and stress. Previous research supports that CBD supplementation provides support to the endocannabinoid system, allowing the brain to better control negative psychological outcomes like fear, stress, and negative mood states.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Ability to take oral medication and be willing to adhere to the dietary supplement regimen (1 capsules per day).
  • Must be in general good health (e.g., no long term health issues that would impact your participation.
  • Moderate self-reported issues with stress, mood, focus, and sleep.

排除标准

  • Current use of selective serotonin reuptake inhibitors or prescription medication for the treatment of depression or anxiety and have not been on a stable dose for more than 60 days.
  • Currently receiving other psychotherapeutic treatment for anxiety or depression.
  • Diagnosed anxiety or depression
  • BMI over 40
  • Known allergic reactions that would require the use of an epi-pen
  • Females who are pregnant or breastfeeding.

结局指标

主要结局

Change in mood as measured by questionnaire

时间窗: 2 months

Feeling states that will be measured include stress, calmness, balance, relaxation, and focus Each endpoint will be reported by the participant on a 7-point scale of perceived frequency and severity of feeling states (Ranging from "Never" to "Everyday", and "None" to "Very severe")

Change in stress and anxiety as measured by questionnaires.

时间窗: 2 months

Feeling states that will be measured include stress, calmness, balance, relaxation, and focus Each endpoint will be reported by the participant on a 7-point scale of perceived frequency and severity of feeling states (Ranging from "Never" to "Everyday", and "None" to "Very severe")

次要结局

  • Change in sleep quality and quantity as measured by digital wearable devices and by self-report(2 months)

研究者

发起方
Prima CBD
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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