Efficacy and Safety of an Essential Oil-Based Product System for Immune Support
dōTERRA International
Summary
This randomized, double-blind, placebo-controlled clinical trial will evaluate the safety and efficacy of an essential oil-based product system for immune support in healthy adolescents and adults aged 18-45 years. Participants will be randomized to receive aromatic, topical, internal, or combined use of the investigational product or matching placebo for 30 days. The aromatic intervention consists of overnight diffusion, the topical intervention consists of diluted application to specified areas prior to bedtime, and the internal intervention consists of oral capsule administration twice daily. Study visits will occur at baseline and at the end of the 30-day intervention period. Primary outcomes include changes in immune-related biomarkers, including complete blood count, comprehensive metabolic panel, salivary immunoglobulin A (IgA), and inflammatory cytokines (IL-6, TNF-α, IL-10). Epigenetic markers will also be evaluated. Secondary outcomes include validated subjective assessments of immune status and overall well-being, as well as evaluation of safety and tolerability. The study includes an adaptive design with interim analysis to assess enrollment and study continuation parameters.
Description
This study is a randomized, double-blind, placebo-controlled, parallel-group clinical trial designed to evaluate the safety and efficacy of a multi-modal essential oil-based product system in healthy adolescents and adults aged 18-45 years. Approximately 20 participants per arm will be enrolled and randomized, with the option for sample size expansion following a planned interim analysis. Participants will be randomized to receive either the investigational product or matching placebo administered through one of four intervention approaches: aromatic use, topical use, internal use, or combine…