NCT05808556

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 11, 2023

Completed
Last Updated

April 11, 2023

Status Verified

April 1, 2023

Enrollment Period

11 months

First QC Date

March 14, 2023

Last Update Submit

April 10, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Systolic blood pressure

    Measure systolic blood pressure in mmHg

    14 days

  • Diastolic blood pressure

    Measure diastolic blood pressure in mmHg

    14 days

  • Pulse rate

    Measure pulse rate in beats/minutes

    14 days

Secondary Outcomes (2)

  • adverse reactions of the respiratory tract, skin, gastrointestinal tract, eye, and central nervous system

    14 days

  • Satisfaction of the product

    14 days

Study Arms (2)

Sticker pads containing lavender and ylang ylang oil

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

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,

Sticker pads containing lavender and ylang ylang oil
PlaceboDEVICE

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.

Placebo group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chulalongkorn Hospital

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 14, 2023

First Posted

April 11, 2023

Study Start

October 2, 2020

Primary Completion

September 1, 2021

Study Completion

September 20, 2021

Last Updated

April 11, 2023

Record last verified: 2023-04

Locations