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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo | Placebo Comparator | A capsule containing only excipients matched in appearance and size to active comparator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botanical extract for anxiety | Dietary Supplement | Capsule containing botanical extracts is self-administered by mouth, taken as needed once per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale Score | Change in anxiety VAS score | 30 minutes after intervention administration |
| Visual Analog Scale Score | Change in anxiety VAS score | 60 minutes after intervention administration |
| Visual Analog Scale Score | Change in anxiety VAS score | 120 minutes after intervention administration |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Tolerance | Throughout study completion, an average of 35 days |
| Measure | Description | Time Frame |
|---|---|---|
| End of Treatment Arm Survey | Satisfaction/desire to take intervention again | Day 14 and Day 35 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alethios Support | Contact | 620-206-8006 | support@alethios.com |
| Name | Affiliation | Role |
|---|---|---|
| Dawna Salter-Farfan, PhD, RD | PLT Health Solutions | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alethios (Virtual) | Recruiting | San Francisco | California | 94117 | United States |
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| Placebo capsule | Dietary Supplement | Capsule containing inert excipients only |
|