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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: Sticker pads containing lavender and ylang ylang oil

• Registration Number: NCT05791266
• Lead Sponsor: Chulalongkorn University

Brief Summary

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 Timeline

• Study Start: 2022-03-21
• Primary Completion: 2023-01-30
• Study Completion: 2023-02-20
• Status Verified: 2023-03
• Study First Submitted: 2023-03-14
• Study First Submitted QC: 2023-03-28
• Last Update Submitted: 2023-03-28
• Study First Posted: 2023-03-30
• Last Update Posted: 2023-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sticker pads containing lavender and ylang ylang oil	Sticker pads containing lavender and ylang ylang oil	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.

Primary Outcome Measures

Name	Time	Method
Adverse reactions of the respiratory tract, skin, eye, and central nervous system	2 hours	The severity scores were 0 (no symptoms) to 3 (severe symptoms)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chulalongkorn Hospital; 🇹🇭 Bangkok, Thailand