Situational AnxietyNCT07511088
Decentralized Study to Evaluate a Dietary Supplement for Episodes of Mild Acute Stress in Healthy People
A study testing Botanical extract for anxiety in people with Situational Anxiety, run by PLT Health Solutions at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Situational Anxiety
- What is being tested?
- Botanical extract for anxiety
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female and male subjects aged >18 and <60 years.
- Self-reported experience of episodic stress or situational anxiety of ≥1 x per week.
- Score of ≥ 40 on a self-assessment of typical anxiety on a Visual Analog Scale where 0 represents "not stressed or anxious" and 100 represents "extremely stressed or anxious."
- Score of ≥ 20 on the Positive Reactivity component of the Perth Emotional Reactivity Scale- Short Form (PERS-S).
- Ability to complete surveys on the Alethios digital platform.
- Subject is only taking well-established, stable doses of prescription and non-prescription medications that are not indicated to treat anxiety disorder.
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- Subject is in generally good health as determined by a review of self-reported medical history and in the opinion of the Principal Investigator.
- Women of child-bearing potential must agree to use a medically approved form of birth control during the study. Acceptable methods of birth control include hormonal - oral (pill), implantable, injectable (shot), ring, or transdermal (patch) contraceptives; mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom; or an intra-uterine device (IUD.
- Subject agrees to abstain from cannabis use for the duration of the study period
- Subject agrees to maintain current dietary habits and abstain from using dietary supplements or herbal products thought to affect a sense of calming, including ashwagandha, L-theanine, or St. John's Wort, for the duration of the study period.
- Individual is aware of the procedures and agrees to participate in the study.
- Participant understands and is willing to sign an Informed eConsent in conformance with 21 CFR Part 50: "Protection of Human Participants."
Who cannot join
- Score of > 9 on the Patient Health Questionnaire (PHQ-9) or any response > 0 on question 9 of the PHQ-9.
- Score > 24 on the Hamilton Anxiety Scale (HAM-A).
- History of severe psychiatric or medical conditions that would interfere with participation.
- Use of >14 alcoholic drinks per week.
- Subject is a regular cannabis user, as defined as equal to or greater than 2 times per week over the prior 6 weeks.
- Individuals with a history of drug abuse or dependence within the past 6 months.
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- Changes to medication treatment for any health condition within the prior 3 months.
- Use of any prescription medication for anxiety.
- Any diagnosis of a mental health condition in the prior 3 months.
- Unstable medical conditions.
- Known hypersensitivity to study product.
- Participant is pregnant, planning to become pregnant, or breastfeeding.
- Pregnant or lactating women or women of child-bearing potential unwilling to use a medically approved form of birth control.
- Inability to comply with digital study requirements.
- Participation in a clinical study within 30 days prior to randomization
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Alethios (Virtual)
San Francisco, California, 94117
Alethios Support, 650-206-8006, support@alethios.com
About this study
Official title: A Decentralized Study Utilizing Non-invasive Measures to Evaluate a Botanical Supplement on Episodes of Mild Acute Stress and Situational Anxiety
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:
- 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?
- On a scale of 1-5, how much would the volunteer like to take the assigned treatment in the future?
- Are any adverse events identified after either treatment, supplement, or placebo?
Read more
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.
- Conditions
- Situational Anxiety
- Being tested
- Botanical extract for anxiety, Placebo capsule
- Keywords
- situational anxiety, acute stress, dietary supplement, decentralized study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botanical extract for anxietyDietary supplement
Capsule containing botanical extracts is self-administered by mouth, taken as needed once per day.
Placebo capsuleDietary supplement
Capsule containing inert excipients only
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement | Active comparator | A 25 mg dose of a standardized extract from the aerial parts of Sceletium tortuosum, delivered by mouth as needed once per day. Receives: Dietary Supplement: Botanical extract for anxiety |
| Placebo | Placebo comparator | A capsule containing only excipients matched in appearance and size to active comparator. Receives: Dietary Supplement: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale Score
Change in anxiety VAS score
Measured: 30 minutes after intervention administration
Visual Analog Scale Score
Change in anxiety VAS score
Measured: 60 minutes after intervention administration
Visual Analog Scale Score
Change in anxiety VAS score
Measured: 120 minutes after intervention administration
Secondary outcomes (1)
Adverse Events
Tolerance
Measured: Throughout study completion, an average of 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start29 Jan 2026
- Primary completion15 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Situational AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PLT Health Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dawna Salter-Farfan, PhD, RD, Principal investigator, PLT Health Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511088
- Sponsor's protocol ID
- PLT002_SSA26
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Decentralized Study Utilizing Non-invasive Measures to Evaluate a Botanical Supplement on Episodes of Mild Acute Stress and Situational Anxiety
- ClinicalTrials.gov ID
- NCT07511088
- Acronym / sponsor ID
- PLT002_SSA26
- Conditions
- Situational Anxiety
- Keywords
- situational anxiety, acute stress, dietary supplement, decentralized study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- PLT Health SolutionsIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- On a scale of 1-5, how much would the volunteer like to take the assigned treatment in the future?
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement | Active comparator | Dietary Supplement: Botanical extract for anxietyA 25 mg dose of a standardized extract from the aerial parts of Sceletium tortuosum, delivered by mouth as needed once per day. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo capsuleA capsule containing only excipients matched in appearance and size to active comparator. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Female and male subjects aged >18 and <60 years.
- Self-reported experience of episodic stress or situational anxiety of ≥1 x per week.
- Score of ≥ 40 on a self-assessment of typical anxiety on a Visual Analog Scale where 0 represents "not stressed or anxious" and 100 represents "extremely stressed or anxious."
- Score of ≥ 20 on the Positive Reactivity component of the Perth Emotional Reactivity Scale- Short Form (PERS-S).
- Ability to complete surveys on the Alethios digital platform.
Key exclusion criteria (15 listed)
- Score of > 9 on the Patient Health Questionnaire (PHQ-9) or any response > 0 on question 9 of the PHQ-9.
- Score > 24 on the Hamilton Anxiety Scale (HAM-A).
- History of severe psychiatric or medical conditions that would interfere with participation.
- Use of >14 alcoholic drinks per week.
- Subject is a regular cannabis user, as defined as equal to or greater than 2 times per week over the prior 6 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botanical extract for anxietyCapsule containing botanical extracts is self-administered by mouth, taken as needed once per day. | Dietary supplement | Dietary Supplement |
| Placebo capsuleCapsule containing inert excipients only | Dietary supplement | Placebo |
Primary outcome
Visual Analog Scale Score
Time frame: 30 minutes after intervention administration
Change in anxiety VAS score
Visual Analog Scale Score
Time frame: 60 minutes after intervention administration
Change in anxiety VAS score
Visual Analog Scale Score
Time frame: 120 minutes after intervention administration
Change in anxiety VAS score
1 secondary outcome
Adverse Events
Time frame: Throughout study completion, an average of 35 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dawna Salter-Farfan, PhD, RD principal investigator
PLT Health Solutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botanical extract for anxiety in people with Situational Anxiety, run by PLT Health Solutions at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alethios Support (620-206-8006, support@alethios.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale Score (time frame: 30 minutes after intervention administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.