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

Conditions

• Situational Anxiety

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Accepted

Interventions

• Botanical extract for anxiety — DIETARY_SUPPLEMENT
  Capsule containing botanical extracts is self-administered by mouth, taken as needed once per day.
• Placebo capsule — DIETARY_SUPPLEMENT
  Capsule containing inert excipients only

Study Details

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.

Key Dates

Start date

Jan 29, 2026

Status verified

Mar 2026

Primary completion

Jun 15, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

250 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Arms

• Active Comparator: 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.
• Placebo Comparator: Placebo
  A capsule containing only excipients matched in appearance and size to active comparator.

Primary Outcome Measure

Visual Analog Scale Score [ Time Frame: 30 minutes after intervention administration ]

Central Contacts

• Alethios Support
  620-206-8006
  [email protected]

Locations (1)

Find similar trials in San Francisco, CA

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