Aromatherapy for Upper Respiratory Health

Not Applicable

Completed

• Conditions: Immune System
• Interventions: Other: Placebo; Other: Essential oil blend

• Registration Number: NCT06190379
• Lead Sponsor: Franklin Health Research

Brief Summary

The purpose of this study is to confirm and quantify the effects of aromatherapy on respiratory health.

Detailed Description

Participants will inhale the scent from an aroma stick every waking hour for the entire duration of a period of respiratory symptoms or 14 days, whichever is shorter. As it is a randomized, placebo-controlled study, some participants will inhale the scent from an aroma stick containing active essential oils while other participants will inhale from an aroma stick containing no essential oils.

Study Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2022-12-05
• Primary Completion: 2023-02-28
• Study Completion: 2023-04-08
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-03
• Last Update Submitted: 2024-01-03
• Study First Posted: 2024-01-05
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

• Provision of signed and dated informed consent form
• Stated willingness and demonstrated ability to comply with all study procedures and availability for the duration of the study
• Gender expression: female
• Aged 20-65
• In good general health
• Exhibiting routine upper respiratory symptoms such as: sneezing, coughing, running nose, headache, general fatigue, or dry or sore throat, etc.
• Ability to utilize the inhaler and be willing to adhere to the regimen

Exclusion Criteria

• Current use of bronchodilators or asthma medications
• Presence of asthma diagnosis or other severe breathing disorder
• Pregnant or trying to conceive
• Known allergic reactions to components of the inhaler, specifically plants in the following families: rutaceae, pinaceae, labiatae, and myrtaceae.
• Treatment with another investigational drug or other intervention within 30 days
• Current smoker
• COVID-19 diagnosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	blank inhaler stick
Intervention	Essential oil blend	Essential oil blend in an inhaler stick

Primary Outcome Measures

Name	Time	Method
severity of respiratory symptoms	14 days	Respiratory symptoms are measured using the Franklin Immune Scale, Respiratory Subdomain, which documents the presence of over 20 symptoms, then rates them by severity. Lower scores mean lesser severity.
duration of respiratory symptoms	daily up to 14 days	Respiratory symptoms are measured daily; total number of days with symptoms will be calculated to produce a duration score

Secondary Outcome Measures

Name	Time	Method
sleep scores using the Franklin Health Sleep Scale	14 days	The Franklin Health Sleep Scale measures the quantity and quality of sleep across 6 subdomains. Scores are ranked on a likert scale, with higher scores indicating greater sleep quality.

Trial Locations

Locations (1)

Franklin Health Research; 🇺🇸 Franklin, Tennessee, United States