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Clary Sage Essential Oil & Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05000424
Recruitment Status : Unknown
Verified April 2022 by Franklin Health Research.
Recruitment status was:  Recruiting
First Posted : August 11, 2021
Last Update Posted : May 2, 2022
Sponsor:
Information provided by (Responsible Party):
Franklin Health Research

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Quality of Life Pregnancy Related Other: Clary Sage Massage Oil Other: Inert Massage Oil Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Clary Sage Essential Oil Inhalation and Third Trimester Quality of Life: A Randomized, Double Blind, Controlled Trial
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
Participants in this group will receive a fragrant plant based massage oil with the addition of clary sage essential oil. The massage oil will be massaged into the upper thighs daily for the duration of the third trimester.
 Other: Clary Sage Massage Oil
This massage oil contains clary sage oil. Five drops will be used daily.
Placebo Comparator: Control
Participants in this group will receive a fragrant plant based massage oil. The massage oil will be massaged into the upper thighs daily for the duration of the third trimester.
 Other: Inert Massage Oil
This massage oil consists entirely of plant based oils. Five drops will be used daily.


Outcome Measures
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Primary Outcome Measures :
  1. Change in salivary estriol levels from pregnancy week 27 to pregnancy week 36. [ Time Frame: Pregnancy week 27 and 36 ]
    salivary estriol levels are collected via the passive drool method and laboratory analyzed

  2. 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). [ Time Frame: Pregnancy week 27 and 36 ]
    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.


Secondary Outcome Measures :
  1. Duration of Pregnancy [ Time Frame: from enrollment to birth, up to 16 weeks ]
    The total length of the pregnancy (in days) from last menstrual period to birth.

  2. Duration of phase 2 of labor [ Time Frame: from the onset of labor to birth, up to 24 hours ]
    The total length of phase 2 of labor (in minutes)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05000424


Locations
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United States, Tennessee
Franklin Health Research Center Recruiting
Franklin, Tennessee, United States, 37067
Contact: Jessie Hawkins, PhD    615-642-1919    j.hawkins@franklinhealth.org   
Sponsors and Collaborators
Franklin Health Research
More Information
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Responsible Party: Franklin Health Research
ClinicalTrials.gov Identifier: NCT05000424    
Other Study ID Numbers: Pro00055623
First Posted: August 11, 2021    Key Record Dates
Last Update Posted: May 2, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Franklin Health Research:
clary sage
essential oil
aromatherapy