Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-24 @ 9:22 AM
Study NCT ID:
NCT02511860
Status:
UNKNOWN
Last Update Posted:
2015-07-30
First Post:
2015-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Burdock and Blood Pressure in African-American Women
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629444', 'term': 'burdock complex'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-29', 'studyFirstSubmitDate': '2015-07-15', 'studyFirstSubmitQcDate': '2015-07-29', 'lastUpdatePostDateStruct': {'date': '2015-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Body fat percentage', 'timeFrame': '6 Weeks'}, {'measure': 'Extracellular/Total Body Water Ratio', 'timeFrame': '6 Weeks'}, {'measure': 'Hemoglobin A1c', 'timeFrame': '6 weeks'}, {'measure': 'Blood urea nitrogen', 'timeFrame': '6 weeks'}, {'measure': 'Creatinine', 'timeFrame': '6 weeks'}, {'measure': 'Fasting Blood Glucose', 'timeFrame': '6 weeks'}, {'measure': 'Liver function tests', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This is a study of women aged 18-65, to determine the physiological effects of consuming burdock root in supplement form. Burdock has long been used by herbalists for its diuretic and blood sugar lowering properties.', 'detailedDescription': 'This study will allow us to determine the effect of burdock consumption on basic laboratory tests such as the complete metabolic panel (CMP) as well as the effect on blood pressure over time. Participants will self-monitor their blood pressures and undergo lab testing. They will also complete symptom inventories to determine subjective factors that change with burdock consumption, such as menstrual water retention. Subjects will undergo electronic body composition testing before and after the intervention.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be able to swallow tablets\n* African-American race\n* Able to travel to our clinic in Santa Monica\n\nExclusion Criteria:\n\n* Severely low blood pressure\n* Hypoglycemia\n* Baseline creatinine over 1.2'}, 'identificationModule': {'nctId': 'NCT02511860', 'briefTitle': 'Burdock and Blood Pressure in African-American Women', 'organization': {'class': 'OTHER', 'fullName': 'Proactive Health Labs'}, 'officialTitle': 'Burdock and Blood Pressure in African-American Women: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '00000001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients will consume a placebo pill containing methylcellulose.', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active', 'description': 'Patients will consume 850 mg of burdock twice per day.', 'interventionNames': ['Dietary Supplement: Burdock']}], 'interventions': [{'name': 'Burdock', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Arctium lappa'], 'description': 'Subjects will consume burdock daily and will undergo laboratory tests to determine the effect of burdock, if any, on organ function.', 'armGroupLabels': ['Active']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Methylcellulose (inert) tablet taken as placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dr De', 'role': 'CONTACT', 'email': 'mde@phlabs.com', 'phone': '3108995577', 'phoneExt': '2'}], 'overallOfficials': [{'name': 'Dr. De', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Proactive Health Labs'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Proactive Health Labs', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}