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:
1. 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? 2. On a scale of 1-5, how much would the volunteer like to take the assigned treatment in the future? 3. 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.
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).
Score of > 9 on the Patient Health Questionnaire (PHQ-9) or any response > 0 on question 9 of the PHQ-9.
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.
Crossover
Botanical extract for anxiety
Dietary supplementCapsule containing botanical extracts is self-administered by mouth, taken as needed once per day.
Placebo capsule
Dietary supplementCapsule containing inert excipients only
Visual Analog Scale Score
Change in anxiety VAS score
Visual Analog Scale Score
Change in anxiety VAS score
Visual Analog Scale Score
Change in anxiety VAS score
Adverse Events
Tolerance
End of Treatment Arm Survey
Satisfaction/desire to take intervention again
Click on the lead sponsor to view all of their trials.
