Clary Sage Essential Oil & Pregnancy

NCT ID: NCT05000424

Last Updated: 2022-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Quality of Life Pregnancy Related

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Clary Sage Massage Oil

Intervention Type OTHER

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.

Group Type PLACEBO_COMPARATOR

Inert Massage Oil

Intervention Type OTHER

This massage oil consists entirely of plant based oils. Five drops will be used daily.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clary Sage Massage Oil

This massage oil contains clary sage oil. Five drops will be used daily.

Intervention Type OTHER

Inert Massage Oil

This massage oil consists entirely of plant based oils. Five drops will be used daily.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nutraceuticals Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Franklin Health Research Center

Franklin, Tennessee, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jessie Hawkins, PhD

Role: primary

615-642-1919

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00055623

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Beneficial Exposome Study
NCT06093464 RECRUITING NA
Moxibustion for Primary Dysmenorrhea
NCT01972906 COMPLETED EARLY_PHASE1