Back to resultsSticker Pad Containing Essential Oil in Volunteer With High Blood Pressure
Primary Purpose
High Blood Pressure
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Sticker pads containing lavender and ylang ylang oil
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for High Blood Pressure
Eligibility Criteria
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
Sites / Locations
- Chulalongkorn Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sticker pads containing lavender and ylang ylang oil
Placebo group
Arm Description
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
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.
Outcomes
Primary Outcome Measures
Systolic blood pressure
Measure systolic blood pressure in mmHg
Diastolic blood pressure
Measure diastolic blood pressure in mmHg
Pulse rate
Measure pulse rate in beats/minutes
Secondary Outcome Measures
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
Satisfaction of the product
Using a visual analogue scale, 0 means not satisfied, 10 means very satisfied
Full Information
NCT ID
NCT05808556
First Posted
March 14, 2023
Last Updated
April 10, 2023
Sponsor
Chulalongkorn University
1. Study Identification
Unique Protocol Identification Number
NCT05808556
Brief Title
Sticker Pad Containing Essential Oil in Volunteer With High Blood Pressure
Official Title
Efficacy and Safety of Sticker Pad Containing Essential Oil in Volunteer With High Blood Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 2, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Blood Pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sticker pads containing lavender and ylang ylang oil
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Sticker pads containing lavender and ylang ylang oil
Intervention Description
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,
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Systolic blood pressure
Description
Measure systolic blood pressure in mmHg
Time Frame
14 days
Title
Diastolic blood pressure
Description
Measure diastolic blood pressure in mmHg
Time Frame
14 days
Title
Pulse rate
Description
Measure pulse rate in beats/minutes
Time Frame
14 days
Secondary Outcome Measure Information:
Title
adverse reactions of the respiratory tract, skin, gastrointestinal tract, eye, and central nervous system
Description
Using a score of 0 to 3, following an increase of severity
Time Frame
14 days
Title
Satisfaction of the product
Description
Using a visual analogue scale, 0 means not satisfied, 10 means very satisfied
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chulalongkorn Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Sticker Pad Containing Essential Oil in Volunteer With High Blood Pressure
We'll reach out to this number within 24 hrs