Study of a Botanical Supplement to Reduce Episodes of Mild Acute Stress and Situational Anxiety in Healthy Adults

What this Trial Is About

Researchers are evaluating a dietary supplements ability to reduce symptoms of acute stress or situational anxiety in healthy adults aged 18 to 60. This decentralized, double-blinded, randomized crossover study aims to compare the effects of a botanical extract supplement to a placebo on anxiety feelings after self-identified stress episodes. The study also assesses participants willingness to continue the treatment and monitors any adverse events that may occur. Participants will take either a 25 mg dose of a standardized extract from Sceletium tortuosum or a matching placebo capsule once per day as needed. The study consists of three periods weeks 1-2 where participants take the first assigned product during stress episodes and rate their anxiety over five hours week 3 with no product or surveys and weeks 4-5 where participants take the alternate product and again rate their anxiety after episodes. Throughout the study, volunteers will use the Alethios digital platform to complete surveys measuring anxiety using a Visual Analog Scale at 30, 60, and 120 minutes after taking the product. Researchers will track adverse events over approximately 35 days and assess participants responses to the supplement compared to placebo. Participants must maintain their regular diet and avoid other calming supplements or cannabis during the study.

Decentralized Study to Evaluate a Dietary Supplement for Episodes of Mild Acute Stress in Healthy People