Quality of LifeNCT05000424
Clary Sage Essential Oil & Pregnancy
A study testing Clary Sage Massage Oil and Inert Massage Oil in people with Quality of Life and Pregnancy Related, run by Nutraceuticals Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Pregnancy Related
- What is being tested?
- Clary Sage Massage Oil and Inert Massage Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20-39
- Lives in the United States
- Pregnant, singleton
- Low risk
- Less than 27 weeks gestation
Who cannot join
- PCOS diagnosis
- Uncontrolled Hypertension (i.e. systolic/diastolic blood pressure > 140/90)
- Gestational Diabetes
- History of Preeclampsia
- Preterm labor
- Incompetent cervix
Show all 9Show fewer
- Allergy to salvia sclarea or related plants
- Known Birth Defects
- Thyroid Disease diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Franklin Health Research Center
Franklin, Tennessee, 37067
Jessie Hawkins, PhD, 615-642-1919, j.hawkins@franklinhealth.org
About this study
Official title: Clary Sage Essential Oil Inhalation and Third Trimester Quality of Life: A Randomized, Double Blind, Controlled Trial
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.
Read the 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.
- Conditions
- Quality of Life, Pregnancy Related
- Being tested
- Clary Sage Massage Oil, Inert Massage Oil
- Keywords
- clary sage, essential oil, aromatherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clary Sage Massage OilOther
This massage oil contains clary sage oil. Five drops will be used daily.
Inert Massage OilOther
This massage oil consists entirely of plant based oils. Five drops will be used daily.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Other: Clary Sage Massage Oil |
| Control | Placebo comparator | 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. Receives: Other: Inert Massage Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
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.
Measured: Pregnancy week 27 and 36
Secondary outcomes (2)
Duration of Pregnancy
The total length of the pregnancy (in days) from last menstrual period to birth.
Measured: from enrollment to birth, up to 16 weeks
Duration of phase 2 of labor
The total length of phase 2 of labor (in minutes)
Measured: from the onset of labor to birth, up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start1 Nov 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutraceuticals Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000424
- Sponsor's protocol ID
- Pro00055623
- Status last verified
- Apr 2022
- First submitted
- 26 Jul 2021
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clary Sage Essential Oil Inhalation and Third Trimester Quality of Life: A Randomized, Double Blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT05000424
- Acronym / sponsor ID
- Pro00055623
- Conditions
- Quality of Life, Pregnancy Related
- Keywords
- clary sage, essential oil, aromatherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nutraceuticals Research InstituteUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Clary Sage Massage OilParticipants 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. |
| Control | Placebo comparator | Other: Inert Massage OilParticipants 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. |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 20-39
- Lives in the United States
- Pregnant, singleton
- Low risk
- Less than 27 weeks gestation
Key exclusion criteria (9 listed)
- PCOS diagnosis
- Uncontrolled Hypertension (i.e. systolic/diastolic blood pressure > 140/90)
- Gestational Diabetes
- History of Preeclampsia
- Preterm labor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clary Sage Massage OilThis massage oil contains clary sage oil. Five drops will be used daily. | Other | Intervention |
| Inert Massage OilThis massage oil consists entirely of plant based oils. Five drops will be used daily. | Other | Control |
Primary outcome
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
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.
2 secondary outcomes
Duration of Pregnancy
Time frame: from enrollment to birth, up to 16 weeks
Duration of phase 2 of labor
Time frame: from the onset of labor to birth, up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clary Sage Massage Oil and Inert Massage Oil in people with Quality of Life and Pregnancy Related, run by Nutraceuticals Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in salivary estriol levels from pregnancy week 27 to pregnancy week 36. (time frame: Pregnancy week 27 and 36). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.