Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2021-11-01
2023-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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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.
Clary Sage Massage Oil
This massage oil contains clary sage oil. Five drops will be used daily.
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.
Inert Massage Oil
This massage oil consists entirely of plant based oils. Five drops will be used daily.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Lives in the United States
* Pregnant, singleton
* Low risk
* Less than 27 weeks gestation
Exclusion Criteria
* 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
20 Years
39 Years
FEMALE
Yes
Sponsors
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Nutraceuticals Research Institute
OTHER
Responsible Party
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Locations
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Franklin Health Research Center
Franklin, Tennessee, United States
Countries
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Facility Contacts
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Other Identifiers
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Pro00055623
Identifier Type: -
Identifier Source: org_study_id
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