Immune SystemNCT06190379
Aromatherapy for Upper Respiratory Health
A study testing Essential oil blend in people with Immune System, run by Nutraceuticals Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to confirm and quantify the effects of aromatherapy on respiratory health. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Immune System
- What is being tested?
- Essential oil blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 8 Apr 2023
- 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 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aromatherapy for Upper Respiratory Health: A Randomized, Placebo Controlled, Triple-Blind Clinical Trial
The purpose of this study is to confirm and quantify the effects of aromatherapy on respiratory health.
Read the detailed description
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
- Immune System
- Being tested
- Essential oil blend, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential oil blendOther
an aroma stick containing a blend of essential oils
PlaceboOther
an aroma stick containing an inert blend of oils
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Essential oil blend in an inhaler stick Receives: Other: Essential oil blend |
| Placebo | Placebo comparator | blank inhaler stick Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: daily up to 14 days
Secondary outcomes (1)
sleep scores using the Franklin Health Sleep Scale
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Dec 2022
- Primary completion28 Feb 2023
- Study completion8 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune SystemStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutraceuticals Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Prodeco Pharma
- Responsible party
- Sponsor
- Investigators
- Jessie Hawkins, PhD, Principal investigator, Nutraceuticals Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190379
- Sponsor's protocol ID
- 22-12-500
- Status last verified
- Jan 2024
- First submitted
- 5 Dec 2022
- Last updated
- 5 Jan 2024
- 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 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aromatherapy for Upper Respiratory Health: A Randomized, Placebo Controlled, Triple-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT06190379
- Acronym / sponsor ID
- 22-12-500
- Conditions
- Immune System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Nutraceuticals Research InstituteUniversity, hospital or other
- Collaborators
- Prodeco Pharma
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 8 Apr 2023 (actual)
- First posted
- 5 Jan 2024 (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 confirm and quantify the effects of aromatherapy on respiratory health.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Essential oil blendEssential oil blend in an inhaler stick |
| Placebo | Placebo comparator | Other: Placeboblank inhaler stick |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Essential oil blendan aroma stick containing a blend of essential oils | Other | Intervention |
| Placeboan aroma stick containing an inert blend of oils | Other | Placebo |
Primary outcome
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.
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
1 secondary outcome
sleep scores using the Franklin Health Sleep Scale
Time frame: 14 days
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 5 Jan 2024.
- 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.
Jessie Hawkins, PhD principal investigator
Nutraceuticals Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Essential oil blend in people with Immune System, 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 7 inclusion and 7 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 5 Jan 2024. 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?
severity of respiratory symptoms (time frame: 14 days). The study lists 2 primary outcomes in all. 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 5 Jan 2024.