High Blood PressureNCT05808556
Sticker Pad Containing Essential Oil in Volunteer With High Blood Pressure
A study testing Sticker pads containing lavender and ylang ylang oil in people with High Blood Pressure, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The aims of the study were to evaluate efficacy and safety of the sticker pads containing lavender and ylang ylang oil in high blood pressure volunteers Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Blood Pressure
- What is being tested?
- Sticker pads containing lavender and ylang ylang oil
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteThailand
- Study dates
- 2 Oct 2020to 20 Sep 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age more than 18 years
- systolic blood pressure of more than 130 mmHg but less than 160 mmHg or diastolic blood pressure more than 80 mmHg but less than 100 mmHg
- no hypertensive medicine
- 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: Efficacy and Safety of Sticker Pad Containing Essential Oil in Volunteer With High Blood Pressure
The aims of the study were to evaluate efficacy and safety of the sticker pads containing lavender and ylang ylang oil in high blood pressure volunteers
Read the detailed description
High blood pressure volunteers were divided into the sticker group or the placebo group. The volunteers attached the pad to their shirt for 3, 7, 10, and 14 days. Blood pressure, pulse rate, adverse reactions, and satisfaction were investigated.
- Conditions
- High Blood Pressure
- Being tested
- Sticker pads containing lavender and ylang ylang oil, Placebo
- Medical subject headings
- Hypertension
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
The sticker pad group attached an sticker pad (0.3% lavender oil and 0.7% ylang ylang oil) to their shirt, close to the right side of the neck, for 14 days,
PlaceboDevice
The placebo group attached a sticker pad without lavender and ylang ylang oil to their shirt, close to the right side of the neck, for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Sticker pads containing lavender and ylang ylang oil | Experimental | The subjects in the sticker pad group attached an sticker pad (0.3% lavender oil and 0.7% ylang ylang oil) to their shirt, close to the right side of the neck, for 14 days Receives: Device: Sticker pads containing lavender and ylang ylang oil |
| Placebo group | Placebo comparator | The placebo group attached a sticker pad without lavender and ylang ylang oil to their shirt, close to the right side of the neck, for 14 days. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Measure systolic blood pressure in mmHg
Measured: 14 days
Diastolic blood pressure
Measure diastolic blood pressure in mmHg
Measured: 14 days
Pulse rate
Measure pulse rate in beats/minutes
Measured: 14 days
Secondary outcomes (2)
adverse reactions of the respiratory tract, skin, gastrointestinal tract, eye, and central nervous system
Using a score of 0 to 3, following an increase of severity
Measured: 14 days
Satisfaction of the product
Using a visual analogue scale, 0 means not satisfied, 10 means very satisfied
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start2 Oct 2020
- Primary completion1 Sep 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Blood PressureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808556
- Sponsor's protocol ID
- EC 21233-20
- Status last verified
- Apr 2023
- First submitted
- 14 Mar 2023
- Last updated
- 11 Apr 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 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Sticker Pad Containing Essential Oil in Volunteer With High Blood Pressure
- ClinicalTrials.gov ID
- NCT05808556
- Acronym / sponsor ID
- EC 21233-20
- Conditions
- High Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 11 Apr 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 efficacy and safety of the sticker pads containing lavender and ylang ylang oil in high blood pressure volunteers
Detailed description
High blood pressure volunteers were divided into the sticker group or the placebo group. The volunteers attached the pad to their shirt for 3, 7, 10, and 14 days. Blood pressure, pulse rate, adverse reactions, and satisfaction were investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sticker pads containing lavender and ylang ylang oil | Experimental | Device: Sticker pads containing lavender and ylang ylang oilThe subjects in the sticker pad group attached an sticker pad (0.3% lavender oil and 0.7% ylang ylang oil) to their shirt, close to the right side of the neck, for 14 days |
| Placebo group | Placebo comparator | Device: PlaceboThe placebo group attached a sticker pad without lavender and ylang ylang oil to their shirt, close to the right side of the neck, for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age more than 18 years
- systolic blood pressure of more than 130 mmHg but less than 160 mmHg or diastolic blood pressure more than 80 mmHg but less than 100 mmHg
- no hypertensive medicine
- 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 oilThe sticker pad group attached an sticker pad (0.3% lavender oil and 0.7% ylang ylang oil) to their shirt, close to the right side of the neck, for 14 days, | Device | Sticker pads containing lavender and ylang ylang oil |
| PlaceboThe placebo group attached a sticker pad without lavender and ylang ylang oil to their shirt, close to the right side of the neck, for 14 days. | Device | Placebo group |
Primary outcome
Systolic blood pressure
Time frame: 14 days
Measure systolic blood pressure in mmHg
Diastolic blood pressure
Time frame: 14 days
Measure diastolic blood pressure in mmHg
Pulse rate
Time frame: 14 days
Measure pulse rate in beats/minutes
2 secondary outcomes
adverse reactions of the respiratory tract, skin, gastrointestinal tract, eye, and central nervous system
Time frame: 14 days
Satisfaction of the product
Time frame: 14 days
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 11 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
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 High Blood Pressure, 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 4 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 11 Apr 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. 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?
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?
Systolic blood pressure (time frame: 14 days). The study lists 3 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 11 Apr 2023.