Immune System
Conditions
Brief summary
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.
Interventions
OTHEREssential oil blend
an aroma stick containing a blend of essential oils
OTHERPlacebo
an aroma stick containing an inert blend of oils
Sponsors
Prodeco Pharma
Nutraceuticals Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| severity of respiratory symptoms | 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 | daily up to 14 days | Respiratory symptoms are measured daily; total number of days with symptoms will be calculated to produce a duration score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sleep scores using the Franklin Health Sleep Scale | 14 days | 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. |
Countries
United States
Outcome results
None listed