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Efficacy and Safety of an Essential Oil-Based Product System for Immune Support

NCT07482644 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Essential Oil Blend (Botanical Combination Product)

A botanical essential oil blend administered via aromatic diffusion, topical application, oral capsule ingestion, or combined use for 30 days. Aromatic administration consists of diffusion of the assigned product overnight (approximately 8 hours) using a standardized protocol. Topical administration consists of application of a diluted preparation to specified skin areas prior to bedtime. Internal administration consists of oral capsule ingestion twice daily with meals. Dosage and administration procedures are standardized across study arms.

DRUG

Placebo

Matching placebo preparations administered via aromatic diffusion, topical application, oral capsule ingestion, or combined use for 30 days using the same procedures and schedule as the active intervention.

Sponsors & Collaborators

  • dōTERRA International

    lead INDUSTRY

Principal Investigators

  • Nicole Stevens, PhD · DoTERRA International LLC.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-04
Primary Completion
2026-06-12
Completion
2026-07-17

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07482644 on ClinicalTrials.gov