Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT05791266
Status:
COMPLETED
Last Update Posted:
2023-03-30
First Post:
2023-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Sticker Pad Containing Essential Oil Containing Lavender and Ylang-ylang Oil
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2023-03-14', 'studyFirstSubmitQcDate': '2023-03-28', 'lastUpdatePostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse reactions of the respiratory tract, skin, eye, and central nervous system', 'timeFrame': '2 hours', 'description': 'The severity scores were 0 (no symptoms) to 3 (severe symptoms)'}], 'secondaryOutcomes': [{'measure': 'Irritation of eye, respiratory, other neurological, and toxicity reaction', 'timeFrame': '2 hours', 'description': 'Using a 0 to 100 scale, following an increase of severity'}, {'measure': 'Systolic blood pressure', 'timeFrame': '2 hours', 'description': 'Measure systemic blood pressure in mmHg'}, {'measure': 'Diastolic blood pressure', 'timeFrame': '2 hours', 'description': 'Measure diastolic blood pressure in mmHg'}, {'measure': 'Pulse rate', 'timeFrame': '2 hours', 'description': 'Measure pulse rate in beats/minutes'}, {'measure': 'Rhinoconjunctivitis quality of life questionnaire', 'timeFrame': '2 hours', 'description': 'Using a score of 1 (no problems) to 5 (severe problem)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The aims of the study were to evaluate safety of sticker pads containing lavender and ylang ylang oil in healthy volunteers.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 to 60 years\n* no allergic history of lavender and ylang ylang oil\n* no dermatological diseases, immunocompromised diseases, seizures, asthma, or respiratory diseases.\n\nExclusion Criteria:\n\n* an unstable condition of other diseases\n* olfactory problems\n* pregnancy\n* lactation'}, 'identificationModule': {'nctId': 'NCT05791266', 'briefTitle': 'Safety of Sticker Pad Containing Essential Oil Containing Lavender and Ylang-ylang Oil', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Safety of Sticker Pad Containing Essential Oil Containing Lavender and Ylang-ylang Oil Attached to the Collar for Decrease Blood Pressure in Healthy Volunteer', 'orgStudyIdInfo': {'id': 'EC 22028-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sticker pads containing lavender and ylang ylang oil', 'description': '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.', 'interventionNames': ['Device: Sticker pads containing lavender and ylang ylang oil']}], 'interventions': [{'name': 'Sticker pads containing lavender and ylang ylang oil', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Sticker pads containing lavender and ylang ylang oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Chulalongkorn Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Pornanong Aramwit', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chulalongkorn University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pornanong Aramwit, Pharm.D., Ph.D', 'investigatorAffiliation': 'Chulalongkorn University'}}}}