Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2026-01-03 @ 7:37 PM
Study NCT ID:
NCT05309161
Status:
COMPLETED
Last Update Posted:
2022-08-03
First Post:
2022-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Testing of Crassocephalum Rabens Extract Capsules
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', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-01', 'studyFirstSubmitDate': '2022-03-16', 'studyFirstSubmitQcDate': '2022-03-24', 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of skin hydration', 'timeFrame': 'Week 0', 'description': 'Corneometer CM825 is used to measure the moisture of upper cheek (unit: Corneometer® unit)'}, {'measure': 'Measurement of skin hydration', 'timeFrame': 'Week 4', 'description': 'Corneometer CM825 is used to measure the moisture of upper cheek (unit: Corneometer® unit)'}, {'measure': 'Measurement of skin brightness', 'timeFrame': 'Week 0', 'description': 'Chroma Meter MM500 is employed to measure the brightness of upper cheek (unit: L\\* value (L\\* range: 0-100)).'}, {'measure': 'Measurement of skin brightness', 'timeFrame': 'Week 4', 'description': 'Chroma Meter MM500 is employed to measure the brightness of upper cheek (unit: L\\* value (L\\* range: 0-100)).'}, {'measure': 'Measurement of skin texture', 'timeFrame': 'Week 0', 'description': 'Visia® skin analysis system is used to measure the skin texture of full face (unit: number of fine lines)'}, {'measure': 'Measurement of skin texture', 'timeFrame': 'Week 4', 'description': 'Visia® skin analysis system is used to measure the skin texture of full face (unit: number of fine lines)'}, {'measure': 'Measurement of skin spots', 'timeFrame': 'Week 0', 'description': 'Visia® skin analysis system is used to measure the skin spots of full face (unit: number of spots)'}, {'measure': 'Measurement of skin spots', 'timeFrame': 'Week 4', 'description': 'Visia® skin analysis system is used to measure the skin spots of full face (unit: number of spots)'}, {'measure': 'Measurement of collagen content', 'timeFrame': 'Week 0', 'description': 'DermaLab® Series SkinLab Combo (Cortex) is employed to measure skin collagen content of upper cheek (unit: collagen density)'}, {'measure': 'Measurement of collagen content', 'timeFrame': 'Week 4', 'description': 'DermaLab® Series SkinLab Combo (Cortex) is employed to measure skin collagen content of upper cheek (unit: collagen density)'}, {'measure': "Measurement of Crow's feet", 'timeFrame': 'Week 0', 'description': 'Visia® skin analysis system is used to measure the skin spots of full face (unit: number of Visia® skin analysis system is used to measure the skin spots of full face (unit: number of fine lines around eyes)'}, {'measure': "Measurement of Crow's feet", 'timeFrame': 'Week 4', 'description': 'Visia® skin analysis system is used to measure the skin spots of full face (unit: number of Visia® skin analysis system is used to measure the skin spots of full face (unit: number of fine lines around eyes)'}, {'measure': 'Measurement of skin elasticity', 'timeFrame': 'Week 0', 'description': 'Cutometer® is used to measure the skin elasticity of upper cheek (unit: mm)'}, {'measure': 'Measurement of skin elasticity', 'timeFrame': 'Week 4', 'description': 'Cutometer® is used to measure the skin elasticity of upper cheek (unit: mm)'}, {'measure': 'Measurement of skin wrinkles', 'timeFrame': 'Week 0', 'description': 'Visia® skin analysis system is used to measure the skin wrinkles of full face (unit: number of wrinkles)'}, {'measure': 'Measurement of skin wrinkles', 'timeFrame': 'Weeks 4', 'description': 'Visia® skin analysis system is used to measure the skin wrinkles of full face (unit: number of wrinkles)'}, {'measure': 'Measurement of skin pores', 'timeFrame': 'Week 0', 'description': 'Visia® skin analysis system is used to measure the skin spots of full face (unit: number of pores)'}, {'measure': 'Measurement of skin pores', 'timeFrame': 'Week 4', 'description': 'Visia® skin analysis system is used to measure the skin spots of full face (unit: number of pores)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aging']}, 'descriptionModule': {'briefSummary': 'This study is to investigate the improveing effects of the Crassocephalum rebens extract on skin conditions in normal people.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age over 20 years\n2. Healthy people\n\nExclusion Criteria:\n\n1. Non-volunteer\n2. Pregnant and lactating women\n3. Hypersensitivity to the assigned product\n4. Diagnosed with skin diseases, liver diseases, kinedy disease, and other severe diseases\n5. Cosmetic, drug, or food allergies\n6. Concurrent aesthetic treatments (e.g., intense pulse light, medical peelings, or laser therapy)\n7. Aceepted aesthetic treatments one month ago before the study\n8. Chronic sun exposure (over 3 hours/day)\n9. The members of the research team'}, 'identificationModule': {'nctId': 'NCT05309161', 'briefTitle': 'Efficacy Testing of Crassocephalum Rabens Extract Capsules', 'organization': {'class': 'INDUSTRY', 'fullName': 'Greenyn Biotechnology Co., Ltd.'}, 'officialTitle': 'Efficacy Testing of Crassocephalum Rabens Extract Capsules', 'orgStudyIdInfo': {'id': '21-129-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'A group (placebo)', 'description': 'Placebo', 'interventionNames': ['Dietary Supplement: Crassocephalum rabens extract']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B group (experimental)', 'description': 'Crassocephalum rabens extract', 'interventionNames': ['Dietary Supplement: Crassocephalum rabens extract']}], 'interventions': [{'name': 'Crassocephalum rabens extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'dosage: a capsule (180 mg)/day; duration: 1 month', 'armGroupLabels': ['A group (placebo)', 'B group (experimental)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71710', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Chia Nan University of Pharmacy ＆ Science', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'overallOfficials': [{'name': 'Chia-Hua Liang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cosmetic Science, Chia Nan University of Pharmacy ＆ Science'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Greenyn Biotechnology Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Chia Nan University of Pharmacy ＆ Science', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}