A Decentralized Study Utilizing Non-invasive Measures to Evaluate a Botanical Supplement on Episodes of Mild Acute Stress and Situational Anxiety

Summary

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.

Eligibility

Age range

18–60 years

Sex

All

Healthy volunteers

Yes

Interventions

• Dietary Supplement
  Botanical extract for anxiety

  Capsule containing botanical extracts is self-administered by mouth, taken as needed once per day.

• Dietary Supplement
  Placebo capsule

  Capsule containing inert excipients only

Location