Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-26 @ 5:41 PM
Study NCT ID:
NCT05808556
Status:
COMPLETED
Last Update Posted:
2023-04-11
First Post:
2023-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sticker Pad Containing Essential Oil in Volunteer With High Blood Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-10', 'studyFirstSubmitDate': '2023-03-14', 'studyFirstSubmitQcDate': '2023-04-10', 'lastUpdatePostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic blood pressure', 'timeFrame': '14 days', 'description': 'Measure systolic blood pressure in mmHg'}, {'measure': 'Diastolic blood pressure', 'timeFrame': '14 days', 'description': 'Measure diastolic blood pressure in mmHg'}, {'measure': 'Pulse rate', 'timeFrame': '14 days', 'description': 'Measure pulse rate in beats/minutes'}], 'secondaryOutcomes': [{'measure': 'adverse reactions of the respiratory tract, skin, gastrointestinal tract, eye, and central nervous system', 'timeFrame': '14 days', 'description': 'Using a score of 0 to 3, following an increase of severity'}, {'measure': 'Satisfaction of the product', 'timeFrame': '14 days', 'description': 'Using a visual analogue scale, 0 means not satisfied, 10 means very satisfied'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['High Blood Pressure']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age more than 18 years\n* 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\n* no hypertensive medicine\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': 'NCT05808556', 'briefTitle': 'Sticker Pad Containing Essential Oil in Volunteer With High Blood Pressure', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Efficacy and Safety of Sticker Pad Containing Essential Oil in Volunteer With High Blood Pressure', 'orgStudyIdInfo': {'id': 'EC 21233-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sticker pads containing lavender and ylang ylang oil', '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', 'interventionNames': ['Device: Sticker pads containing lavender and ylang ylang oil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', '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.', 'interventionNames': ['Device: Placebo']}], 'interventions': [{'name': 'Sticker pads containing lavender and ylang ylang oil', 'type': 'DEVICE', '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,', 'armGroupLabels': ['Sticker pads containing lavender and ylang ylang oil']}, {'name': 'Placebo', 'type': 'DEVICE', '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.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Chulalongkorn Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pornanong Aramwit, Pharm.D., Ph.D', 'investigatorAffiliation': 'Chulalongkorn University'}}}}