Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-01 @ 3:52 PM
Study NCT ID:
NCT02114957
Status:
COMPLETED
Last Update Posted:
2014-04-15
First Post:
2014-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Decursin/Decursinol Angelate (CognIQTM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'lastUpdateSubmitDate': '2014-04-14', 'studyFirstSubmitDate': '2014-04-11', 'studyFirstSubmitQcDate': '2014-04-14', 'lastUpdatePostDateStruct': {'date': '2014-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma concentration versus time curve (AUC) of decursin, decursinol angelate (DA) and decursinol', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 6, 8, 12 , 24, 48 hours post-dose'}], 'secondaryOutcomes': [{'measure': 'vital signs, plasma biochemistry and blood cell counts of subjects after consumption the study herb', 'timeFrame': '0 and 24 hours post-dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bio-availability', 'decursin', 'decursinol angelate', 'decursinol', 'subjects'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '25695490', 'type': 'DERIVED', 'citation': 'Zhang J, Li L, Hale TW, Chee W, Xing C, Jiang C, Lu J. Single oral dose pharmacokinetics of decursin and decursinol angelate in healthy adult men and women. PLoS One. 2015 Feb 19;10(2):e0114992. doi: 10.1371/journal.pone.0114992. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'This study is to investigate how human bodies absorb and metabolize two herbal drugs. The information is critical for drug development and could not be obtained from any other studies using animals. The two herbal drugs are decursin and decursinol angelate (DA) which naturally exist in a traditional herb Angelica gigas Nakai (AGN). Preclinical and clinical studies indicated that AGN and decursin/DA were quite safe to animals and human.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Health subjects weighing between 50 to 91 kilograms (110 to 200 pounds)\n* Subjects 18 to 65 years of age\n* Subjects having normal hepatic, renal and bone marrow function as assessed by history, physical and clinical chemistry analysis\n\nExclusion Criteria:\n\n* Subjects positive for HIV, HBV and HCV\n* Subjects with diabetes-due to length of fasting\n* Subjects regularly taking any kind of prescription medications\n* Subjects taking oral contraception, hormone-containing IUDs, contraception implants, or Depo medroxyprogesterone injections\n* Subjects taking any food or herbal supplements containing AGN (e.g. CognIQTM, D-Cursinol, Decursinol-50™, Ache Action™, Fast-Acting Joint Formula, EstroG-100™) within 30 days of the study.\n* Female subjects that are pregnant, \\<6 months postpartum, or breastfeeding women.'}, 'identificationModule': {'nctId': 'NCT02114957', 'briefTitle': 'Pharmacokinetics of Decursin/Decursinol Angelate (CognIQTM)', 'organization': {'class': 'OTHER', 'fullName': 'Texas Tech University Health Sciences Center'}, 'officialTitle': 'Single Oral Dose Pharmacokinetics of Decursin/Decursinol Angelate in Healthy Adult Men and Women', 'orgStudyIdInfo': {'id': 'A12-3742'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study herb', 'interventionNames': ['Dietary Supplement: 800mg dietary supplement CognIQTM (4 capsules) by oral at hour 0']}], 'interventions': [{'name': '800mg dietary supplement CognIQTM (4 capsules) by oral at hour 0', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['study herb']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79106', 'city': 'Amarillo', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Research Unit, School of Medicine, Texas Tech University Health Sciences Center', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}], 'overallOfficials': [{'name': 'Jinhui Zhang, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas Tech University Health Sciences Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas Tech University Health Sciences Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}