Safety of Sticker Pad Containing Essential Oil Containing Lavender and Ylang-ylang Oil

Study Overview
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Brief Summary
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The aims of the study were to evaluate safety of sticker pads containing lavender and ylang ylang oil in healthy volunteers.

Detailed Description
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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

Official Title
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Safety of Sticker Pad Containing Essential Oil Containing Lavender and Ylang-ylang Oil Attached to the Collar for Decrease Blood Pressure in Healthy Volunteer

Conditions
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Healthy

Intervention / Treatment
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* Device: Sticker pads containing lavender and ylang ylang oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 to 60 years no allergic history of lavender and ylang ylang oil no dermatological diseases, immunocompromised diseases, seizures, asthma, or respiratory diseases. Exclusion Criteria: an unstable condition of other diseases olfactory problems pregnancy lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sticker pads containing lavender and ylang ylang oil<br>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. | Device: Sticker pads containing lavender and ylang ylang oil<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse reactions of the respiratory tract, skin, eye, and central nervous system | The severity scores were 0 (no symptoms) to 3 (severe symptoms) | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irritation of eye, respiratory, other neurological, and toxicity reaction | Using a 0 to 100 scale, following an increase of severity | 2 hours | 
| Systolic blood pressure | Measure systemic blood pressure in mmHg | 2 hours | 
| Diastolic blood pressure | Measure diastolic blood pressure in mmHg | 2 hours | 
| Pulse rate | Measure pulse rate in beats/minutes | 2 hours | 
| Rhinoconjunctivitis quality of life questionnaire | Using a score of 1 (no problems) to 5 (severe problem) | 2 hours |