Sticker Pad Containing Essential Oil in Volunteer With High Blood Pressure

High Blood Pressure Clinical Trial

Official title:

Efficacy and Safety of Sticker Pad Containing Essential Oil in Volunteer With High Blood Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05808556
• Other study ID #: EC 21233-20
• Status: Completed
• Phase: N/A
• Start date: October 2, 2020
• Est. completion date: September 20, 2021

Study information

• Verified date: April 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 efficacy and safety of the sticker pads containing lavender and ylang ylang oil in high blood pressure volunteers

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 20, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• an unstable condition of other diseases
• olfactory problems
• pregnancy
• lactation

Related Conditions & MeSH terms

• High Blood Pressure
• Hypertension

Intervention

Device:
• Sticker pads containing lavender and ylang ylang oil
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
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.

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	Systolic blood pressure	Measure systolic blood pressure in mmHg	14 days
Primary	Diastolic blood pressure	Measure diastolic blood pressure in mmHg	14 days
Primary	Pulse rate	Measure pulse rate in beats/minutes	14 days
Secondary	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	14 days
Secondary	Satisfaction of the product	Using a visual analogue scale, 0 means not satisfied, 10 means very satisfied	14 days