Aromatherapy for Upper Respiratory Health

Aromatherapy for Upper Respiratory Health: A Randomized, Placebo Controlled, Triple-Blind Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Immune System
• Intervention / Treatment: Other: Essential oil blend; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • Franklin Health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Essential oil blend in an inhaler stick	Other: Essential oil blend; an aroma stick containing a blend of essential oils
Placebo Comparator: Placebo; blank inhaler stick	Other: Placebo; an aroma stick containing an inert blend of oils

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
severity of respiratory symptoms	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.	14 days
duration of respiratory symptoms	Respiratory symptoms are measured daily; total number of days with symptoms will be calculated to produce a duration score	daily up to 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sleep scores using the Franklin Health Sleep Scale	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.	14 days

Collaborators and Investigators

• Sponsor: Franklin Health Research
• Collaborators: Prodeco Pharma
• Investigators: Principal Investigator: Jessie Hawkins, PhD, Franklin Health Research

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): April 8, 2023

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: January 3, 2024
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 22-12-500

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No