Aromatherapy for Upper Respiratory Health

Immune System Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06190379
• Other study ID #: 22-12-500
• Status: Completed
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: April 8, 2023

Study information

• Verified date: January 2024
• Source: Franklin Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 8, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Immune System

Intervention

Other:
• Essential oil blend
an aroma stick containing a blend of essential oils
• Placebo
an aroma stick containing an inert blend of oils

Locations

Country	Name	City	State
United States	Franklin Health Research	Franklin	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Franklin Health Research	Prodeco Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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