Essential Oils for Healthy Subjects

Overseen By Allison Zhang, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Pregnancy, Breastfeeding, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how regular exposure to essential oils affects overall health and wellness. Participants will use different essential oils in a diffuser while sleeping, with breaks to observe any changes. This trial suits those interested in natural remedies and curious about the potential benefits of essential oils. Ideal participants are U.S. residents without allergies to trees like cypress or cedar and no history of epilepsy. As an unphased trial, this study offers a unique opportunity to explore the natural benefits of essential oils in a structured setting.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Natural Compound A, like other essential oils, might cause minor irritation, affecting skin, eyes, or breathing. Handle it carefully to avoid these issues.

For Natural Compound B, studies have found similar concerns. It can irritate skin, eyes, and breathing, and it is also flammable. Use it safely, especially near open flames.

Both compounds are generally safe when used properly. Their availability in stores suggests they are safe for most people. However, always follow guidelines to minimize any possible side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore the potential benefits of essential oils for promoting relaxation and sleep quality. Unlike conventional sleep aids that often rely on pharmaceuticals, these treatments use natural compounds like essential oils, which might offer a gentler, more holistic approach. The treatments are delivered through a diffuser, creating an easy and non-invasive experience. By assessing different oils — Natural Compounds A, B, and C — researchers aim to uncover any unique benefits each might have in enhancing sleep and overall well-being.

What evidence suggests that this trial's treatments could be effective for holistic health outcomes?

Research shows that essential oils, such as Natural Compound A, offer various health benefits, often due to their germ-fighting and anti-inflammatory properties. Some studies suggest they may also aid sleep and reduce anxiety. In this trial, participants will use Natural Compound A, Natural Compound B, or a control compound at different stages. Natural Compound B, which contains oils from the Boswellia plant, has been used in traditional medicine for its calming effects. It is known for reducing inflammation and may also promote relaxation. While both compounds appear promising, results can vary, and further research is needed to confirm these effects. ^{6 7 8 9 10}

Who Is on the Research Team?

Michael Snyder, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who can read, speak, and understand English and live in the US. It's not suitable for those who are pregnant or breastfeeding, have epilepsy, mental incapacity, cognitive impairments, or allergies to certain plant families like redwoods and cedars.

Inclusion Criteria

You possess a proficient understanding of the English language.

You are residing in the United States.

Exclusion Criteria

You are currently breastfeeding.

I have epilepsy.

You are allergic to certain types of plants like redwoods, junipers, cypress, cedar, fir, and sequoia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cycle 1

Participants use diffused 'Natural Compound A' (essential oil) in a diffuser every night when sleeping

4 weeks

Weekly visits for monitoring

Cycle 2

Wash-out period where participants do not use compounds/diffuser

4 weeks

Weekly visits for monitoring

Cycle 3

Participants use diffused 'Natural Compound B' (essential oil) in a diffuser every night when sleeping

4 weeks

Weekly visits for monitoring

Cycle 4

Post-intervention observation period where participants do not use compounds/diffuser

4 weeks

Weekly visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Natural Compound A
• Natural Compound B

Trial Overview The study tests two natural compounds (essential oils A & B) to see if they promote holistic health benefits through regular exposure. Participants will not know which compound they're receiving as part of the study's design.

How Is the Trial Designed?

Group I: Group C- Natural Compound C to Natural Compound A to Natural Compound B Experimental Treatment 3 Interventions

* Cycle 1 (4 weeks): use diffused "Natural Compound C" (control) in a diffuser every night when sleeping * Cycle 2 (4 weeks): will not use compounds/diffuser (wash-out period) * Cycle 3 (4 weeks): use diffused "Natural Compound A" (essential oil) in a diffuser every night when sleeping * Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period) * Cycle 3 (4 weeks): use diffused "Natural Compound B" (essential oil) in a diffuser every night when sleeping * Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period) There will be 3 natural compounds; the intervention compounds essential oils and are commercially available and there is a control compound (water). They will be used as intended with diffusers.

Group II: Group B- Natural Compound B to Natural Compound C to Natural Compound A Experimental Treatment 3 Interventions

* Cycle 1 (4 weeks): use diffused "Natural Compound B" (essential oil) in a diffuser every night when sleeping * Cycle 2 (4 weeks): will not use compounds/diffuser (wash-out period) * Cycle 3 (4 weeks): use diffused "Natural Compound C" (control) in a diffuser every night when sleeping * Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period) * Cycle 3 (4 weeks): use diffused "Natural Compound A" (essential oil) in a diffuser every night when sleeping * Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period) There will be 3 natural compounds; the intervention compounds essential oils and are commercially available and there is a control compound (water). They will be used as intended with diffusers.

Group III: Group A- Natural Compound A to Natural Compound B to Natural Compound C Experimental Treatment 3 Interventions

* Cycle 1 (4 weeks): use diffused "Natural Compound A" (essential oil) in a diffuser every night when sleeping * Cycle 2 (4 weeks): will not use compounds/diffuser (wash-out period) * Cycle 3 (4 weeks): use diffused "Natural Compound B" (essential oil) in a diffuser every night when sleeping * Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period) * Cycle 3 (4 weeks): use diffused "Natural Compound C" (control) in a diffuser every night when sleeping * Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period) There will be 3 natural compounds; the intervention compounds essential oils and are commercially available and there is a control compound (water). They will be used as intended with diffusers.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

Essential oils are complex mixtures derived from various plant sources, and their composition can vary significantly based on factors like the plant family, extraction method, and environmental conditions.

Despite being natural substances, essential oils can be toxic, highlighting the need for careful evaluation and regulation to ensure their safe use in cosmetics, drugs, and food.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Essential oils: renewal of interest and toxicity. Vigan, M.[2022]

Essential oils (EOs) have a wide range of potential health benefits, including support for digestive health, metabolic regulation, and immune system enhancement, as highlighted by recent clinical trials and preclinical research.

Specific EOs, such as green and black cumin, bergamot, and peppermint, show promise in managing conditions like irritable bowel syndrome, inflammatory bowel disease, and even neuroprotection, suggesting they could be valuable in functional foods and dietary supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plant Essential Oils as Healthy Functional Ingredients of Nutraceuticals and Diet Supplements: A Review. Matera, R., Lucchi, E., Valgimigli, L.[2023]

Essential oils, while popular for their therapeutic uses, can pose safety risks, including toxic reactions from oral or topical use, especially in vulnerable populations like children and pregnant women.

The regulation of essential oils is complex, with varying classifications (medicine, food supplement, etc.) in Belgium, and many essential oils lack sufficient clinical trial data to support their efficacy, despite public misconceptions about their safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Essential oils: good advice by the pharmacist is necessary]. Vandersteen, L.[2018]

Essential oils, derived from plants, have gained attention for their germicidal, antifungal, antiviral, and anti-parasitic properties, suggesting they could be a source of new therapeutic agents alongside traditional treatments.

While essential oils may positively influence health and mental well-being, there is a risk of side effects and the potential for developing resistant pathogens, highlighting the need for quality standards in their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of Essential Oils on Infectious Agents. Piątkowska, E., Rusiecka-Ziółkowska, J.[2018]

Essential oils (EOs) have a wide range of therapeutic activities, including anti-inflammatory, antimicrobial, and analgesic effects, which can work both individually and synergistically to promote health.

To ensure the safety and efficacy of EOs, it is crucial to analyze their complex chemical profiles using gas-chromatography-mass detection methods, which helps establish standards for their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Essential oils in medicine: principles of therapy. Pisseri, F., Bertoli, A., Pistelli, L.[2008]

Essential oils (EOs) are concentrated natural plant products with various applications in modern medicine, including treatment for respiratory diseases, pain management, and stress relief.

While EOs can be beneficial, there are risks associated with their use, such as allergic reactions, overdosing, and variability in substance quality, which must be carefully considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Aromatherapy - From Traditional and Scientific Evidence into Clinical Practice]. Steflitsch, W.[2018]

Natural essential oil constituents from aromatic herbs and dietary plants have various mechanisms that contribute to cancer prevention and treatment, including antioxidant and antimutagenic properties, immune function enhancement, and modulation of drug resistance.

The review highlights the importance of these constituents' structural categories and their molecular anticancer mechanisms, suggesting their potential as effective chemopreventive agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticancer activity of essential oils: a review. Bhalla, Y., Gupta, VK., Jaitak, V.[2014]

Essential oils (EOs) possess antibacterial, antiviral, and anti-inflammatory properties, making them valuable for both treating and preventing various diseases, as well as for use in cosmetics and food.

The complex mixture of compounds in EOs allows for multi-target activity, which may enhance their therapeutic effects compared to single compounds, indicating their potential role in integrative medicine and future health applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Essential Oils as Multicomponent Mixtures and Their Potential for Human Health and Well-Being. Bunse, M., Daniels, R., Gründemann, C., et al.[2023]

In a pilot study involving 40 patients in a rheumatology ward, nursing interventions that included essential oils led to significant improvements in specific aspects of well-being, although they did not enhance overall general well-being.

The study suggests that nursing with essential oils is more effective than standard nursing without oils, as patients reported more positive experiences related to their care when essential oils were used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nursing without and with essential oils: a controlled study of patients in an acute rheumatologic department]. Christen, L., Christen, S., Waldmeier, V., et al.[2019]

A new guide has been created to assess the safety of essential oils used as flavor ingredients, focusing on their complete chemical composition and the variability in their mixtures.

The guide evaluates the safety of essential oil constituents by organizing them into congeneric groups based on their chemical properties, ensuring that all potentially harmful components are thoroughly assessed while allowing for flexibility in evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A procedure for the safety evaluation of natural flavor complexes used as ingredients in food: essential oils. Smith, RL., Cohen, SM., Doull, J., et al.[2006]

A new tiered approach for determining safe recommended doses of essential oils (EOs) as food supplements has been proposed, focusing on the toxicological evaluation of each constituent's concentration.

This methodology assesses the genotoxic potential of constituents and establishes safety margins, ensuring that recommended doses are safe without requiring new animal testing, thus promoting safer consumption of EOs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicological safety assessment of essential oils used as food supplements to establish safe oral recommended doses. Sartori Tamburlin, I., Roux, E., Feuillée, M., et al.[2022]

Citations

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Essential Oils: Chemistry and Pharmacological Activities The data show that the multiplicity of pharmacological properties of essential oils occurs due to the chemical diversity in their composition and their ability ...

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Aromatherapy: Do Essential Oils Really Work? Some studies indicate that there's a benefit to using essential oils while others show no improvement in symptoms. Clinical trials have looked at whether ...

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Chemical profiling and biological assessment of essential ... Despite the widespread use of Artemisia herba alba in traditional medicine, the anticancer properties of its EO have been infrequently studied.

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Essential oils: classification, labelling, and safety data sheet This post give practical tips on how essential oils are handled in chemical regulations, particularly for hazard classification, labelling, and safety data ...

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The Essential Oil Company SAFETY DATA SHEET Do not eat, drink or smoke when using this product. Wear personal protective equipment. Do not breathe vapors or spray mist. Use only in area provided with ...