NCT03465176

Brief Summary

This study evaluates the effects of an inhaled blend of essential oils on fatigue scores among women who have hypothyroidism. Half of the participants will receive an essential oil blend to inhale daily for two weeks while the other half will serve as controls and inhale a carrier oil.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

August 1, 2018

Status Verified

July 1, 2018

Enrollment Period

9 months

First QC Date

March 8, 2018

Last Update Submit

July 31, 2018

Conditions

FatigueHypothyroidism

Keywords

aromatherapyfatiguehypothyroidismessential oils

Outcome Measures

Primary Outcomes (1)

  • 83-item Multidimensional Symptoms of Fatigue Inventory

    This measurement collects self reported fatigue scores at baseline and at the end of each week of the intervention. Each item is scored from 0-4, with higher scores indicating greater levels of fatigue.

    2 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

The women in this arm will receive an essential oil blend to inhale each afternoon for two weeks.

Other: Aromatherapy Blend

Control

PLACEBO COMPARATOR

The women in this arm will receive an odorless vegetable based oil to inhale each afternoon for two weeks as a control/placebo.

Other: Placebo

Interventions

Aromatherapy BlendOTHER

The essential oil intervention is a blend of plant derived oils which have been distilled from crude plant matter and analyzed in a laboratory to identify chemical composition.

Intervention
PlaceboOTHER

The placebo substance is an odorless vegetable oil derived from avocados.

Control

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • female
  • diagnosed with hypothyroidism
  • otherwise healthy

You may not qualify if:

  • history of thyroid cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Franklin Institute of Wellness

Franklin, Tennessee, 37067, United States

Location

MeSH Terms

Conditions

FatigueHypothyroidism

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsThyroid DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2018

First Posted

March 14, 2018

Study Start

July 11, 2017

Primary Completion

March 30, 2018

Study Completion

May 31, 2018

Last Updated

August 1, 2018

Record last verified: 2018-07

Locations

US(1)