Aromatherapy for Upper Respiratory Health

NCT06190379 | Completed

• 1 other identifier: 22-12-500
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Immune System

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• sleep scores using the Franklin Health Sleep Scale

  14 days

Study Arms (2)

Intervention

EXPERIMENTAL

Essential oil blend in an inhaler stick

Other: Essential oil blend

Placebo

PLACEBO COMPARATOR

blank inhaler stick

Other: Placebo

Interventions

Essential oil blend OTHER

an aroma stick containing a blend of essential oils

Intervention

Placebo OTHER

an aroma stick containing an inert blend of oils

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nutraceuticals Research Institute: lead
• Prodeco Pharma: collaborator

Study Sites (1)

Franklin Health Research

Franklin, Tennessee, 37067, United States

Location

Study Officials

• Jessie Hawkins, PhD

  Nutraceuticals Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: January 5, 2024
• Study Start: December 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: April 8, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)