Recruiting

Clary Sage & Pregnancy

Sponsor:

Nutraceuticals Research Institute

Code:

NCT05000424

Conditions

Quality of Life

Pregnancy Related

Eligibility Criteria

Sex: Female

Age: 20 - 39

Healthy Volunteers: Accepted

Interventions

Clary Sage Massage Oil

Inert Massage Oil

Study Details

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.

Conditions

Quality of Life

Pregnancy Related

Study ID

NCT05000424

Start date

Nov 1, 2021

Status verified date

Apr, 2022

Completion date

Feb 28, 2023

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 20 - 39

Healthy Volunteers: 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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Change in salivary estriol levels from pregnancy week 27 to pregnancy week 36. [ Time Frame: Pregnancy week 27 and 36 ]
  • 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 ]

Central Contacts and Locations

Locations

Franklin Health Research Center

Recruiting

Franklin, Tennessee, United States, 37067

Contacts

Jessie Hawkins, PhD

615-642-1919j.hawkins@franklinhealth.org

More Information

Sponsor

Nutraceuticals Research Institute

Last update posted

May 2, 2022

Last verified

Apr, 2022

Keywords

  • clary sage
  • essential oil
  • aromatherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nutraceuticals Research Institute on 2022-05-02.