Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of Feel Free Classic Tonic on Self-Perceived Stress and Pharmacokinetic Profile in Healthy Adults
Led by Botanic Tonics, LLC · Updated on 2026-05-01
165
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
Sponsors
B
Botanic Tonics, LLC
Lead Sponsor
N
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Feel Free Classic Tonic, a herbal supplement containing kava and kratom, on stress and anxiety in healthy adults aged 21 to 55. This randomized, double-blind, placebo-controlled study aims to understand how the tonic influences self-reported stress, physiological stress markers, and how its ingredients are absorbed and processed in the body through a pharmacokinetic sub-study. Participants are randomly assigned to one of three groups: a placebo group, a group receiving a higher dose of the tonic (380 mg Kava root extract and 1480 mg dried Kratom leaf powder per bottle), or a group receiving a half-strength dose (190 mg Kava root extract and 740 mg dried Kratom leaf powder per bottle). The study compares these groups over 29 days, including single and multiple-day dosing periods. During the study, participants will complete questionnaires like the Perceived Stress Scale-10 and State-Trait Anxiety Inventory to assess stress and anxiety levels. Researchers will also measure physiological markers such as cortisol, alpha-amylase, and heart rate, especially during the Trier Social Stress Test-Arithmetic. Participants must follow lifestyle and diet restrictions, abstain from alcohol, and may attend video calls for coordination. The primary outcome is the change in perceived stress from baseline to day 29, with various secondary measures tracking anxiety and physiological stress responses.
CONDITIONS
Brief Title
Effects of Feel Free® Classic Tonic on Stress and Pharmacokinetics in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 21 to 55 years at screening
- Self-reported stress with a Perceived Stress Scale-10 (PSS-10) score between 14 and 26
- In good general health without uncontrolled diseases or conditions
- Use nicotine, kava, or kratom products three or fewer times in the past 3 months and willing to abstain 14 days before baseline and during study
- Body mass index between 18.5 and 29.9 kg/m2 at screening and baseline
- Agree to follow restrictions on treatments, lifestyle, diet, and contraceptive use
- Abstain from alcohol for the entire study duration
- Willing and able to give voluntary consent, complete questionnaires, and follow study procedures
- For sub-study participants: have suitable veins for repeated blood draws and able to attend video calls with coordinators
You will not qualify if you...
- Currently pregnant, lactating, or planning pregnancy during the study
- Known allergy or intolerance to study products or rescue medications
- Positive drug, cotinine, or breath alcohol tests at screening or baseline
- Abnormal respiratory rate or oxygen saturation at screening or baseline
- Elevated liver enzyme levels or other clinically significant lab abnormalities
- Participation in other clinical trials or investigational product use within 28 days before baseline
- Gastrointestinal conditions preventing swallowing or digestion
- Diabetes or thyroid disease
- High blood pressure (systolic 140 mmHg or diastolic 90 mmHg) or low blood pressure (systolic <90 mmHg or diastolic <60 mmHg) unless clinically insignificant
- History of heart disease, blood clotting disorders, kidney or liver impairment
- Known genetic enzyme polymorphisms affecting drug metabolism
- Active asthma or asthma attack in past 5 years
- Recent or ongoing psychiatric disorders requiring treatment or hospitalization
- History of cancer within 5 years except localized skin or in situ cervical cancer
- Recent significant blood loss or donation
- Major surgery within 3 months before screening or planned surgery during study
- History of alcohol or substance abuse
- High addictive tendency indicated by LDQ score 21
- Use of anxiolytic or sleep aids within 4 weeks before baseline
- Regular consumption of more than two standard alcoholic drinks per day for 4 weeks
- Excessive caffeine intake over 500 mg per day
- Other medical conditions or treatments that may affect study participation or safety
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.
1 visit (in-person)
Duration - 29 days
Participants take one of two dose levels of the Feel Free® Classic Tonic or placebo daily to assess effects on self-perceived stress and physiological stress markers.
Baseline visit on Day 1 and follow-up visit on Day 29
Trial Site Locations
Total: 1 location
1
ApexTrials
Guelph, Ontario, Canada, N1G 0B4
Actively Recruiting
Research Team
A
Ambreen Atif, MD
S
Stephanie Recker
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here