Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT04368169
Status:
COMPLETED
Last Update Posted:
2021-02-26
First Post:
2020-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of an Aromatic Botanical Extract on Respiratory Health.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Double Blind'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are recruited through a single health practice and randomized through block randomization to one of 2 groups: botanical extract or inert control.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-25', 'studyFirstSubmitDate': '2020-04-27', 'studyFirstSubmitQcDate': '2020-04-27', 'lastUpdatePostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline on the 44-part Wisconsin Upper Respiratory Symptom Survey (WURSS-44) at day 3.', 'timeFrame': 'Baseline and Day 3', 'description': 'The Wisconsin Upper Respiratory Symptom Survey (WURSS-44) is a validated, self reported instrument assessing overall respiratory health. Possible scores range from 0 to 308 with lower scores indicating fewer respiratory complaints.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Health']}, 'descriptionModule': {'briefSummary': 'This study is a randomized, double blind, placebo controlled, intervention study evaluating the effect of an aromatic botanical extract on overall respiratory health among otherwise healthy adults.', 'detailedDescription': 'After being informed about the study and providing informed consent, patients with respiratory complaints will be randomized into a double blind placebo controlled trial of the botanical extract.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'self identify as female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age: 18-60 years\n* currently experiencing respiratory symptoms\n* otherwise healthy\n\nExclusion Criteria:\n\n* underlying respiratory conditions\n* pregnant, breastfeeding, or trying to conceive\n* tobacco use in the home\n* allergies to any of the ingredients'}, 'identificationModule': {'nctId': 'NCT04368169', 'briefTitle': 'The Effects of an Aromatic Botanical Extract on Respiratory Health.', 'organization': {'class': 'OTHER', 'fullName': 'Nutraceuticals Research Institute'}, 'officialTitle': 'The Effects of an Aromatic Botanical Extract on Respiratory Health.', 'orgStudyIdInfo': {'id': '20-4-9100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aromatic Extract', 'description': 'Participants receive the aromatic botanical extract orally every 4-6 waking hours for 3 days.', 'interventionNames': ['Dietary Supplement: Teramune Botanical Extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants receive the placebo matching the botanical extract orally every 4-6 waking hours for 3 days.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Teramune Botanical Extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Combination blend of aromatic plant extracts in an emulsifier carrier.', 'armGroupLabels': ['Aromatic Extract']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Emulsifier carrier without active supplement ingredients.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37067', 'city': 'Franklin', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Franklin School of Integrative Health Sciences', 'geoPoint': {'lat': 35.92506, 'lon': -86.86889}}], 'overallOfficials': [{'name': 'Jessie H Hawkins, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nutraceuticals Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nutraceuticals Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}