## Protocol Section
### Identification Module
**NCT ID:** NCT06190379

**Brief Title:** Aromatherapy for Upper Respiratory Health

**Official Title:** Aromatherapy for Upper Respiratory Health: A Randomized, Placebo Controlled, Triple-Blind Clinical Trial

#### Organization Study ID Info
**ID:** 22-12-500
#### Organization
**Class:** OTHER
**Full Name:** Franklin Health Research
### Status Module
#### Completion Date
**Date:** 2023-04-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-01-05

**Type:** ACTUAL

**Last Update Submit Date:** 2024-01-03

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-02-28

**Type:** ACTUAL

#### Start Date
**Date:** 2022-12-01

**Type:** ACTUAL

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2024-01-05
**Type:** ACTUAL
**Study First Submit Date:** 2022-12-05
**Study First Submit QC Date:** 2024-01-03
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Prodeco Pharma

#### Lead Sponsor

**Class:** OTHER

**Name:** Franklin Health Research

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Immune System

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 45

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Essential oil blend in an inhaler stick

**Intervention Names:**

- Other: Essential oil blend

**Label:** Intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** blank inhaler stick

**Intervention Names:**

- Other: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention

**Description:** an aroma stick containing a blend of essential oils

**Name:** Essential oil blend

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** an aroma stick containing an inert blend of oils

**Name:** Placebo

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** severity of respiratory symptoms

**Time Frame:** 14 days

**Description:** Respiratory symptoms are measured daily; total number of days with symptoms will be calculated to produce a duration score

**Measure:** duration of respiratory symptoms

**Time Frame:** daily up to 14 days

#### Secondary Outcomes

**Description:** 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.

**Measure:** sleep scores using the Franklin Health Sleep Scale

**Time Frame:** 14 days

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 20 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Franklin

**Country:** United States

**Facility:** Franklin Health Research

**State:** Tennessee

**Zip:** 37067

#### Overall Officials

**Official 1:**

**Affiliation:** Franklin Health Research

**Name:** Jessie Hawkins, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
