A Decentralized Study Utilizing Non-invasive Measures to Evaluate a Botanical Supplement on Episodes of Mild Acute Stress and Situational Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Visual Analog Scale Score
研究概览
简要总结
The purpose of this decentralized, two-arm, double-blinded, crossover clinical study is to test the efficacy of a supplement to reduce symptoms of acute stress or situational anxiety in healthy volunteers. The main questions it aims to answer are:
- Does a dietary supplement reduce feelings of anxiety after self-identified episodes of stress or anxiety when compared to their experience after taking a placebo?
- On a scale of 1-5, how much would the volunteer like to take the assigned treatment in the future?
- Are any adverse events identified after either treatment, supplement, or placebo?
The study volunteers will:
During weeks 1-2, self-identify episodes of acute stress or situational anxiety and rate feelings of anxiety over the next five hours after taking the study product assigned for Period 1.
During week 3, volunteers will not take any study product nor complete any surveys.
During weeks 4-5, self-identify an episode of acute stress or situational anxiety and rate feelings of anxiety over the next five hours after taking the study product assigned for Period 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female and male subjects aged >18 and <60 years.
- •Self-reported experience of episodic stress or situational anxiety of ≥1 x per week.
- •Score of ≥ 40 on a self-assessment of typical anxiety on a Visual Analog Scale where 0 represents "not stressed or anxious" and 100 represents "extremely stressed or anxious."
- •Score of ≥ 20 on the Positive Reactivity component of the Perth Emotional Reactivity Scale- Short Form (PERS-S).
- •Ability to complete surveys on the Alethios digital platform.
- •Subject is only taking well-established, stable doses of prescription and non-prescription medications that are not indicated to treat anxiety disorder.
- •Subject is in generally good health as determined by a review of self-reported medical history and in the opinion of the Principal Investigator.
- •Women of child-bearing potential must agree to use a medically approved form of birth control during the study. Acceptable methods of birth control include hormonal - oral (pill), implantable, injectable (shot), ring, or transdermal (patch) contraceptives; mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom; or an intra-uterine device (IUD.
- •Subject agrees to abstain from cannabis use for the duration of the study period
- •Subject agrees to maintain current dietary habits and abstain from using dietary supplements or herbal products thought to affect a sense of calming, including ashwagandha, L-theanine, or St. John's Wort, for the duration of the study period.
- •Individual is aware of the procedures and agrees to participate in the study.
- •Participant understands and is willing to sign an Informed eConsent in conformance with 21 CFR Part 50: "Protection of Human Participants."
排除标准
- •Score of > 9 on the Patient Health Questionnaire (PHQ-9) or any response > 0 on question 9 of the PHQ-
- •Score > 24 on the Hamilton Anxiety Scale (HAM-A).
- •History of severe psychiatric or medical conditions that would interfere with participation.
- •Use of >14 alcoholic drinks per week.
- •Subject is a regular cannabis user, as defined as equal to or greater than 2 times per week over the prior 6 weeks.
- •Individuals with a history of drug abuse or dependence within the past 6 months.
- •Changes to medication treatment for any health condition within the prior 3 months.
- •Use of any prescription medication for anxiety.
- •Any diagnosis of a mental health condition in the prior 3 months.
- •Unstable medical conditions.
- •Known hypersensitivity to study product.
- •Participant is pregnant, planning to become pregnant, or breastfeeding.
- •Pregnant or lactating women or women of child-bearing potential unwilling to use a medically approved form of birth control.
- •Inability to comply with digital study requirements.
- •Participation in a clinical study within 30 days prior to randomization
研究组 & 干预措施
Dietary Supplement
A 25 mg dose of a standardized extract from the aerial parts of Sceletium tortuosum, delivered by mouth as needed once per day.
干预措施: Botanical extract for anxiety (Dietary Supplement)
Placebo
A capsule containing only excipients matched in appearance and size to active comparator.
干预措施: Placebo capsule (Dietary Supplement)
结局指标
主要结局
Visual Analog Scale Score
时间窗: 30 minutes after intervention administration
Change in anxiety VAS score
Visual Analog Scale Score
时间窗: 120 minutes after intervention administration
Change in anxiety VAS score
Visual Analog Scale Score
时间窗: 60 minutes after intervention administration
Change in anxiety VAS score
次要结局
- Adverse Events(Throughout study completion, an average of 35 days)