Covid19NCT04980573
Essential Oils and Post COVID-19 Fatigue
A study testing Aromatherapy in people with Covid19 and Fatigue, run by Nutraceuticals Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 49 yearsHealthy volunteers can take part
- What is being tested?
- Aromatherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2021to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- Abnormal pulmonary function
- Chest pain
- Recurring headaches
- Uncontrolled hypertension
- Chronic Fatigue Syndrome diagnosis
- Persistent fatigue prior to COVID-19 diagnosis
- Hypothyroidism
Trial locations and contacts
1 site in 1 country.
United States1 site
Franklin Health Research Center
Franklin, Tennessee, 37067
About this study
Official title: The Effects of Aromatherapy on Post COVID-19 Fatigue: A Randomized, Double Blind, Controlled Trial
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.
Read the detailed 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.
- Being tested
- Aromatherapy, Placebo
- Keywords
- essential oils, aromatherapy, energy
- Medical subject headings
- COVID-19, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AromatherapyOther
The aromatherapy intervention consists of inhaling a fragrant oil extracted from citrus peels, plant resins, and leaves.
PlaceboOther
The placebo intervention consists of inhaling an oil extracted from inert plant matter.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants receive a bottle of plant-based oil to inhale twice daily for 14 days. Receives: Other: Aromatherapy |
| Placebo | Placebo comparator | Participants receive a bottle of inert oil to inhale twice daily for 14 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Day 14
Secondary outcomes (1)
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.
Measured: Baseline and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start5 Aug 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutraceuticals Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Young Living Essential Oils
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980573
- Sponsor's protocol ID
- 21-07-0300
- Status last verified
- Jan 2022
- First submitted
- 26 Jul 2021
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Aromatherapy on Post COVID-19 Fatigue: A Randomized, Double Blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT04980573
- Acronym / sponsor ID
- 21-07-0300
- Keywords
- essential oils, aromatherapy, energy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Nutraceuticals Research InstituteUniversity, hospital or other
- Collaborators
- Young Living Essential Oils
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: AromatherapyParticipants receive a bottle of plant-based oil to inhale twice daily for 14 days. |
| Placebo | Placebo comparator | Other: PlaceboParticipants receive a bottle of inert oil to inhale twice daily for 14 days. |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AromatherapyThe aromatherapy intervention consists of inhaling a fragrant oil extracted from citrus peels, plant resins, and leaves. | Other | Intervention |
| PlaceboThe placebo intervention consists of inhaling an oil extracted from inert plant matter. | Other | Placebo |
Primary outcome
Change from baseline on the Multidimensional Fatigue Symptom Inventory (MFSI) at day 14.
Time frame: Baseline and 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.
1 secondary outcome
Change from baseline to day 14 on the Patient Health Questionnaire (PHQ-9)
Time frame: Baseline and Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy in people with Covid19 and Fatigue, run by Nutraceuticals Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline on the Multidimensional Fatigue Symptom Inventory (MFSI) at day 14. (time frame: Baseline and Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.