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Completed

NCT Number: NCT05791266

Safety of Sticker Pad Containing Essential Oil Containing Lavender and Ylang-ylang Oil

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

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chulalongkorn Hospital

Bangkok, 10330, Thailand

About this study

The lavender and ylang ylang oil 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. Adverse reactions, irritation score, and quality of life were assessed. Blood pressure and pulse rate were also measured

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18 to 60 years
  • no allergic history of lavender and ylang ylang oil
  • no dermatological diseases, immunocompromised diseases, seizures, asthma, or respiratory diseases.

Exclusion criteria

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

Treatment and study plan

Sticker pads containing lavender and ylang ylang oil

Device

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.

Primary outcomes

  1. Adverse reactions of the respiratory tract, skin, eye, and central nervous system

    Time frame: 2 hours

    The severity scores were 0 (no symptoms) to 3 (severe symptoms)

Secondary outcomes

  1. Irritation of eye, respiratory, other neurological, and toxicity reaction

    Time frame: 2 hours

    Using a 0 to 100 scale, following an increase of severity

  2. Systolic blood pressure

    Time frame: 2 hours

    Measure systemic blood pressure in mmHg

  3. Diastolic blood pressure

    Time frame: 2 hours

    Measure diastolic blood pressure in mmHg

  4. Pulse rate

    Time frame: 2 hours

    Measure pulse rate in beats/minutes

  5. Rhinoconjunctivitis quality of life questionnaire

    Time frame: 2 hours

    Using a score of 1 (no problems) to 5 (severe problem)

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

Safety of Sticker Pad Containing Essential Oil Containing Lavender and Ylang-ylang Oil Attached to the Collar for Decrease Blood Pressure in Healthy Volunteer

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 30, 2023
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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