HealthyNCT05791266
Safety of Sticker Pad Containing Essential Oil Containing Lavender and Ylang-ylang Oil
A study testing Sticker pads containing lavender and ylang ylang oil in people with Healthy, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The aims of the study were to evaluate safety of sticker pads containing lavender and ylang ylang oil in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sticker pads containing lavender and ylang ylang oil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteThailand
- Study dates
- 21 Mar 2022to 20 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18 to 60 years
- no allergic history of lavender and ylang ylang oil
- no dermatological diseases, immunocompromised diseases, seizures, asthma, or respiratory diseases.
Who cannot join
- an unstable condition of other diseases
- olfactory problems
- pregnancy
- lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety of Sticker Pad Containing Essential Oil Containing Lavender and Ylang-ylang Oil Attached to the Collar for Decrease Blood Pressure in Healthy Volunteer
The aims of the study were to evaluate safety of sticker pads containing lavender and ylang ylang oil in healthy volunteers.
Read the detailed description
The lavender and ylang ylang oil pad was attached to the shirts of healthy volunteers for 2 hours. The outcomes were evaluated before, during and 30 minutes after removal of the pad. Adverse reactions, irritation score, and quality of life were assessed. Blood pressure and pulse rate were also measured
- Conditions
- Healthy
- Being tested
- Sticker pads containing lavender and ylang ylang oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sticker pads containing lavender and ylang ylang oilDevice
Sticker pads , size 160 mm2, were produced by a certified ISO 9001 manufacturer and contained 0.3% lavender oil and 0.7% ylang ylang oil. The sticker pad was attached to the shirts of healthy volunteers for 2 hours. The outcomes were evaluated before, during and 30 minutes after removal of the pad.
| Study group | Role | What they receive |
|---|---|---|
| Sticker pads containing lavender and ylang ylang oil | Experimental | Sticker pads , size 160 mm2, were produced by a certified ISO 9001 manufacturer and contained 0.3% lavender oil and 0.7% ylang ylang oil. The sticker pad was attached to the shirts of healthy volunteers for 2 hours. The outcomes were evaluated before, during and 30 minutes after removal of the pad. Receives: Device: Sticker pads containing lavender and ylang ylang oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse reactions of the respiratory tract, skin, eye, and central nervous system
The severity scores were 0 (no symptoms) to 3 (severe symptoms)
Measured: 2 hours
Secondary outcomes (5)
Irritation of eye, respiratory, other neurological, and toxicity reaction
Using a 0 to 100 scale, following an increase of severity
Measured: 2 hours
Systolic blood pressure
Measure systemic blood pressure in mmHg
Measured: 2 hours
Diastolic blood pressure
Measure diastolic blood pressure in mmHg
Measured: 2 hours
Pulse rate
Measure pulse rate in beats/minutes
Measured: 2 hours
Rhinoconjunctivitis quality of life questionnaire
Using a score of 1 (no problems) to 5 (severe problem)
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start21 Mar 2022
- Primary completion30 Jan 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
- Investigators
- Pornanong Aramwit, Study director, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791266
- Sponsor's protocol ID
- EC 22028-20
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2023
- Last updated
- 30 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Sticker Pad Containing Essential Oil Containing Lavender and Ylang-ylang Oil Attached to the Collar for Decrease Blood Pressure in Healthy Volunteer
- ClinicalTrials.gov ID
- NCT05791266
- Acronym / sponsor ID
- EC 22028-20
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 30 Mar 2023 (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 aims of the study were to evaluate safety of sticker pads containing lavender and ylang ylang oil in healthy volunteers.
Detailed description
The lavender and ylang ylang oil pad was attached to the shirts of healthy volunteers for 2 hours. The outcomes were evaluated before, during and 30 minutes after removal of the pad. Adverse reactions, irritation score, and quality of life were assessed. Blood pressure and pulse rate were also measured
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sticker pads containing lavender and ylang ylang oil | Experimental | Device: Sticker pads containing lavender and ylang ylang oilSticker pads , size 160 mm2, were produced by a certified ISO 9001 manufacturer and contained 0.3% lavender oil and 0.7% ylang ylang oil. The sticker pad was attached to the shirts of healthy volunteers for 2 hours. The outcomes were evaluated before, during and 30 minutes after removal of the pad. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 18 to 60 years
- no allergic history of lavender and ylang ylang oil
- no dermatological diseases, immunocompromised diseases, seizures, asthma, or respiratory diseases.
Key exclusion criteria (4 listed)
- an unstable condition of other diseases
- olfactory problems
- pregnancy
- lactation
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 |
|---|---|---|
| Sticker pads containing lavender and ylang ylang oilSticker pads , size 160 mm2, were produced by a certified ISO 9001 manufacturer and contained 0.3% lavender oil and 0.7% ylang ylang oil. The sticker pad was attached to the shirts of healthy volunteers for 2 hours. The outcomes were evaluated before, during and 30 minutes after removal of the pad. | Device | Sticker pads containing lavender and ylang ylang oil |
Primary outcome
Adverse reactions of the respiratory tract, skin, eye, and central nervous system
Time frame: 2 hours
The severity scores were 0 (no symptoms) to 3 (severe symptoms)
5 secondary outcomes
Irritation of eye, respiratory, other neurological, and toxicity reaction
Time frame: 2 hours
Systolic blood pressure
Time frame: 2 hours
Diastolic blood pressure
Time frame: 2 hours
Pulse rate
Time frame: 2 hours
Rhinoconjunctivitis quality of life questionnaire
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
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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.
Pornanong Aramwit study director
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sticker pads containing lavender and ylang ylang oil in people with Healthy, run by Chulalongkorn University at 1 site in Thailand.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 30 Mar 2023. 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 Thailand. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse reactions of the respiratory tract, skin, eye, and central nervous system (time frame: 2 hours). 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 30 Mar 2023.