Effects of Feel Free® Classic Tonic on Stress and Pharmacokinetics in Healthy Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-55
SponsorBotanic Tonics, LLC
About this trial
This study is being conducted to assess the effects of the Feel Free® Classic Tonic on stress in healthy adults. The goal is to see whether the tonic can help reduce self-perceived and physiological stress and provide information on how its ingredients are processed in the body.
Eligibility criteria
Qualifiers
Adults who are between 21 - 55 years of age (inclusive) at screening.
Have self-reported stress at screening and baseline scoring 14 - 26 (inclusive) on the PSS-10.
In good general health (no uncontrolled diseases or conditions) as deemed by the investigator and is able to consume the study product.
Not currently using, defined as ≤ 3 uses in the past 3 months prior to Baseline, any nicotine containing products (patches, gums, vapes etc.), kava products, and/or kratom products, and willing to abstain starting 14 days prior to Baseline and throughout the study.
Disqualifiers
Individuals who are lactating, planning to become pregnant during the study, or pregnant as confirmed by a positive pregnancy test during study visits.
Have a known sensitivity, intolerability, or allergy to any of the study products, their excipients, or rescue medication.
Demonstrates a positive urine drug screen test for compounds listed in Table 9 Screening or Baseline visits, a positive urine cotinine test at the Screening or Baseline visits, or a positive breath alcohol test at Baseline visit.
Have abnormal RR or SpO2 measurements at Screening or Baseline at the discretion of the investigator.
Trial design
Treatments tested in this trial
- Placebo
- Kava and Kratom Herbal Supplement
- Kava and Kratom Herbal Supplement
Treatment groups
165 Participants
are divided into 3 treatment groupsSponsors and collaborators
Botanic Tonics, LLC
Lead sponsor
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Collaborator
Source ClinicalTrials.gov