Sticker Pad Containing Essential Oil in Volunteer With High Blood Pressure

April 10, 2023 updated by: Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Chulalongkorn Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sticker pads containing lavender and ylang ylang oil
The subjects in 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
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 Comparator: Placebo group
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic blood pressure
Time Frame: 14 days
Measure systolic blood pressure in mmHg
14 days
Diastolic blood pressure
Time Frame: 14 days
Measure diastolic blood pressure in mmHg
14 days
Pulse rate
Time Frame: 14 days
Measure pulse rate in beats/minutes
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse reactions of the respiratory tract, skin, gastrointestinal tract, eye, and central nervous system
Time Frame: 14 days
Using a score of 0 to 3, following an increase of severity
14 days
Satisfaction of the product
Time Frame: 14 days
Using a visual analogue scale, 0 means not satisfied, 10 means very satisfied
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2020

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

September 20, 2021

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

April 10, 2023

First Posted (Actual)

April 11, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC 21233-20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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