Aromatherapy for Upper Respiratory Health

NCT ID: NCT06190379

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-04-08

Brief Summary

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

Detailed Description

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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.

Conditions

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Immune System

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Intervention

Essential oil blend in an inhaler stick

Group Type EXPERIMENTAL

Essential oil blend

Intervention Type OTHER

an aroma stick containing a blend of essential oils

Placebo

blank inhaler stick

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

an aroma stick containing an inert blend of oils

Interventions

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Essential oil blend

an aroma stick containing a blend of essential oils

Intervention Type OTHER

Placebo

an aroma stick containing an inert blend of oils

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Prodeco Pharma

UNKNOWN

Sponsor Role collaborator

Nutraceuticals Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jessie Hawkins, PhD

Role: PRINCIPAL_INVESTIGATOR

Nutraceuticals Research Institute

Locations

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Franklin Health Research

Franklin, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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22-12-500

Identifier Type: -

Identifier Source: org_study_id

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