Clary Sage Essential Oil & Pregnancy

Quality of Life Clinical Trial

Official title:

Clary Sage Essential Oil Inhalation and Third Trimester Quality of Life: A Randomized, Double Blind, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05000424
• Other study ID #: Pro00055623
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: February 28, 2023

Study information

• Verified date: April 2022
• Source: Franklin Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the potential for clary sage essential oil to support overall health, wellbeing, and quality of life during the third trimester of pregnancy among otherwise healthy adult women.

Description:

Women will be informed of the opportunity to participate through their care providers, childbirth educators, or doulas. If they meet inclusion criteria, they will be given a brochure describing the risks and benefits of the study and the informed consent paperwork.

If they provide consent, they will be randomized to one of two groups: active essential oil and inert placebo. Both groups will receive a 4-ounce bottle of oil to apply daily during the third trimester of pregnancy. Those in the placebo group will be given an inert plant oil. Those in the intervention group will be given the same oil with the addition of clary sage essential oil.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 28, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

Inclusion Criteria:

• Age 20-39

• Lives in the United States

• Pregnant, singleton

• Low risk

• Less than 27 weeks gestation

Exclusion Criteria:

• PCOS diagnosis

• Uncontrolled Hypertension (i.e. systolic/diastolic blood pressure > 140/90)

• Gestational Diabetes

• History of Preeclampsia

• Preterm labor

• Incompetent cervix

• Allergy to salvia sclarea or related plants

• Known Birth Defects

• Thyroid Disease diagnosis

Related Conditions & MeSH terms

• Pregnancy Related
• Quality of Life

Intervention

Other:
• Clary Sage Massage Oil
This massage oil contains clary sage oil. Five drops will be used daily.
• Inert Massage Oil
This massage oil consists entirely of plant based oils. Five drops will be used daily.

Locations

Country	Name	City	State
United States	Franklin Health Research Center	Franklin	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Franklin Health Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in salivary estriol levels from pregnancy week 27 to pregnancy week 36.	salivary estriol levels are collected via the passive drool method and laboratory analyzed	Pregnancy week 27 and 36
Primary	Change in quality of life from week 27 to 36 of the pregnancy using the World Health Organization's Quality of Life, Brief-Form Scale (WHOQOL-BREF).	This one survey measures overall quality of life through. It contains 26 questions across 4 domains. Questions are scored on a 1-5 likert scale with higher scores indicating higher quality of life.	Pregnancy week 27 and 36
Secondary	Duration of Pregnancy	The total length of the pregnancy (in days) from last menstrual period to birth.	from enrollment to birth, up to 16 weeks
Secondary	Duration of phase 2 of labor	The total length of phase 2 of labor (in minutes)	from the onset of labor to birth, up to 24 hours