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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Sticker pads containing lavender and ylang ylang oil

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Chulalongkorn Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Study Director: Pornanong Aramwit, Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): February 20, 2023

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: EC 22028-20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No