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OpenTrials
Completed

NCT Number: NCT06190379

Aromatherapy for Upper Respiratory Health

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

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Key information

Conditions

Immune System

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Franklin Health Research

Franklin, Tennessee, 37067, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Essential oil blend

Other

an aroma stick containing a blend of essential oils

Placebo

Other

an aroma stick containing an inert blend of oils

Primary outcomes

  1. severity of respiratory symptoms

    Time frame: 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.

  2. duration of respiratory symptoms

    Time frame: 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 outcomes

  1. sleep scores using the Franklin Health Sleep Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nutraceuticals Research Institute

Other

Collaborators

  • Prodeco Pharma

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 5, 2024
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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