NCT05791266

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Mar 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

March 14, 2023

Last Update Submit

March 28, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Irritation of eye, respiratory, other neurological, and toxicity reaction

    2 hours

  • Systolic blood pressure

    2 hours

  • Diastolic blood pressure

    2 hours

  • Pulse rate

    2 hours

  • Rhinoconjunctivitis quality of life questionnaire

    2 hours

Study Arms (1)

Sticker pads containing lavender and ylang ylang oil

EXPERIMENTAL

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.

Device: Sticker pads containing lavender and ylang ylang oil

Interventions

Sticker pads containing lavender and ylang ylang oilDEVICE

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.

Sticker pads containing lavender and ylang ylang oil

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 18 to 60 years
  • no allergic history of lavender and ylang ylang oil
  • 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

Study Officials

  • Pornanong Aramwit

    Chulalongkorn University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 14, 2023

First Posted

March 30, 2023

Study Start

March 21, 2022

Primary Completion

January 30, 2023

Study Completion

February 20, 2023

Last Updated

March 30, 2023

Record last verified: 2023-03

Locations

TH(1)