Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:36 AM
Study NCT ID:
NCT07469527
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Feel Free® Classic Tonic on Stress and Pharmacokinetics in Healthy Adults
Sponsor:
Botanic Tonics, LLC
Organization:
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
This is a randomized, double-blind, parallel, 3-arm, placebo-controlled study to assess the effects of two dose levels of the Feel Free® Classic Tonic on stress in healthy adults. The primary goal is to evaluate how the tonic affects self-reported and physiological measures of stress and anxiety. A pharmacokinetic sub-study will assess how the tonic's components are absorbed and processed. The tonic contains kava and kratom, botanicals traditionally used for relaxation and mood support, and early data suggest it is generally well tolerated.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: