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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05791266
• Other study ID #: EC 22028-20
• Status: Completed
• Phase: N/A
• Start date: March 21, 2022
• Est. completion date: February 20, 2023

Study information

• Verified date: March 2023
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 20, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
Thailand	Chulalongkorn Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

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