Essential Oils and Post COVID-19 Fatigue

Covid19 Clinical Trial

Official title:

The Effects of Aromatherapy on Post COVID-19 Fatigue: A Randomized, Double Blind, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04980573
• Other study ID #: 21-07-0300
• Status: Completed
• Phase: N/A
• Start date: August 5, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: January 2022
• Source: Franklin Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy of plant based aromas on energy levels among otherwise healthy female survivors of COVID-19.

Description:

After being informed about the study, participants will provide informed consent, then will be randomized into one of two groups in a 1:1 ratio. Participants will either inhale an inert blend twice a day or an active aroma twice a day for 14 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 49 Years

Eligibility

Inclusion Criteria:

• Age 19-49

• Lives in the United States

• Otherwise Healthy

• COVID-19 Diagnosis between December 1, 2020 and March 31, 2021

• Decreased energy or fatigue at a level that was not present prior to the diagnosis

Exclusion Criteria:

• Positive COVID-19 test any time before December 1, 2020

• Positive COVID-19 test any time after March 31, 2021

• COVID vaccine of any type scheduled during the intervention period or the week prior to the start of the study

• Allergy to any of the ingredients

• Pregnant, trying to conceive, or breastfeeding

• Regular smokers in the home

• Abnormal pulmonary function

• Chest pain

• Recurring headaches

• Uncontrolled hypertension

• Chronic Fatigue Syndrome diagnosis

• Persistent fatigue prior to COVID-19 diagnosis

• Hypothyroidism

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Fatigue

Intervention

Other:
• Aromatherapy
The aromatherapy intervention consists of inhaling a fragrant oil extracted from citrus peels, plant resins, and leaves.
• Placebo
The placebo intervention consists of inhaling an oil extracted from inert plant matter.

Locations

Country	Name	City	State
United States	Franklin Health Research Center	Franklin	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Franklin Health Research	Young Living Essential Oils

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline on the Multidimensional Fatigue Symptom Inventory (MFSI) at day 14.	The MFSI is a validated, 83 question scale measuring fatigue levels across ten domains. Each question is scored from 0-5 on a Likert scale, with higher scores indicating higher levels of fatigue.	Baseline and Day 14
Secondary	Change from baseline to day 14 on the Patient Health Questionnaire (PHQ-9)	This survey includes 9 questions regarding levels of depression. Each question is scored from 0-3 on a Likert scale, with higher scores indicating higher levels of depression.	Baseline and Day 14