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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
250
Capsule containing botanical extracts is self-administered by mouth, taken as needed once per day.
Capsule containing inert excipients only
Alethios (Virtual)
San Francisco, California, United States
RECRUITINGVisual Analog Scale Score
Change in anxiety VAS score
Time frame: 30 minutes after intervention administration
Visual Analog Scale Score
Change in anxiety VAS score
Time frame: 60 minutes after intervention administration
Visual Analog Scale Score
Change in anxiety VAS score
Time frame: 120 minutes after intervention administration
Adverse Events
Tolerance
Time frame: Throughout study completion, an average of 35 days
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