Actively Recruiting
A Decentralized Study Using Non-invasive Measures to Evaluate a Botanical Supplement for Mild Acute Stress and Situational Anxiety
Led by PLT Health Solutions · Updated on 2026-04-06
250
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a dietary supplement's 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.
CONDITIONS
Brief Title
Decentralized Study to Evaluate a Dietary Supplement for Episodes of Mild Acute Stress in Healthy People
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female and male subjects aged over 18 and under 60 years
- Self-reported experience of episodic stress or situational anxiety at least once per week
- Score of 40 or higher on a self-assessment Visual Analog Scale for typical anxiety
- Score of 20 or higher on the Positive Reactivity component of the Perth Emotional Reactivity Scale- Short Form
- Ability to complete surveys on the Alethios digital platform
- Taking only stable doses of medications not used to treat anxiety
- Generally good health based on medical history and investigator opinion
- Women of child-bearing potential must use approved birth control during the study
- Agreement to abstain from cannabis during the study
- Agreement to maintain current diet and avoid certain calming supplements during the study
- Awareness of study procedures and willingness to participate
- Willingness to sign informed eConsent conforming to regulations
You will not qualify if you...
- Score above 9 on the Patient Health Questionnaire (PHQ-9) or any positive response to question 9
- Score above 24 on the Hamilton Anxiety Scale (HAM-A)
- History of severe psychiatric or medical conditions that interfere with participation
- Consumption of more than 14 alcoholic drinks per week
- Regular cannabis use (two or more times per week in past 6 weeks)
- History of drug abuse or dependence within past 6 months
- Changes to medication treatment in the prior 3 months
- Use of any prescription medication for anxiety
- Diagnosis of mental health condition in past 3 months
- Unstable medical conditions
- Known hypersensitivity to study product
- Pregnancy, planning pregnancy, or breastfeeding
- Unwillingness to use approved birth control if of child-bearing potential
- Inability to comply with digital study requirements
- Participation in another clinical study within 30 days prior to randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 35 days
Participants self-administer a botanical extract or placebo capsule by mouth as needed once per day during episodes of mild acute stress or situational anxiety.
Trial Site Locations
Total: 1 location
1
Alethios (Virtual)
San Francisco, California, United States, 94117
Actively Recruiting
Research Team
A
Alethios Support
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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