Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2026-02-20 @ 6:42 PM
Study NCT ID:
NCT02093650
Status:
UNKNOWN
Last Update Posted:
2014-09-25
First Post:
2014-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Black Cohosh Extract for Treatment of Moderate to Severe Menopausal Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713173', 'term': 'black cohosh root extract'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-09-23', 'studyFirstSubmitDate': '2014-03-19', 'studyFirstSubmitQcDate': '2014-03-19', 'lastUpdatePostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The changes in Kupperman Index', 'timeFrame': 'baseline, week 4, week 8 and week 12', 'description': 'Kupperman index questionnaire at baseline, 4, 8 and 12 weeks'}], 'secondaryOutcomes': [{'measure': 'A change in MENQOL', 'timeFrame': 'baseline and week 12', 'description': 'MENQOL questionnaire measurement at baseline and 12 weeks'}, {'measure': 'The changes in daily hot flushes frequency', 'timeFrame': 'baseline, week 4, week 8 and week 12', 'description': 'Daily hot flushes frequency over 12 weeks treatment'}, {'measure': 'Global satisfaction', 'timeFrame': 'week 12', 'description': 'Overall patient satisfaction 0 - 10 scale'}, {'measure': 'A change in liver function test', 'timeFrame': 'baseline and week 12', 'description': 'Changes in liver function test from baseline and 12 weeks'}, {'measure': 'adverse events', 'timeFrame': 'week 4, week 8 and week 12', 'description': 'frequency of adverse events'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Menopausal symptoms', 'menopause related quality of life', 'black cohosh', 'cimicifuga racemosa', 'MENQOL', 'Kupperman index', 'KI', 'liver function tests'], 'conditions': ['Menopause', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'Compare the treatment efficacy of black cohosh extract 80 mg daily and placebo for moderate to severe menopausal symptoms', 'detailedDescription': 'Compare the treatment efficacy of black cohosh extract 80 mg/day an placebo for moderate to severe menopausal symptoms with Kupperman menopausal index and MENQOL'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age at least 40 years\n* Peri or post menopause\n* Moderate to severe menopausal symptoms (Kupperman index at least 20)\n\nExclusion Criteria:\n\n* Use hormonal treatment or other treatments within 4 weeks\n* Use atorvastatin azathioprine or cyclosporin within 4 weeks\n* BMI at least 30 kg m2\n* Allergic to drug or components\n* Liver disease or abnormal liver function test\n* Psychiatric disease\n* Alcoholic or drug abuse\n* Vegetarian'}, 'identificationModule': {'nctId': 'NCT02093650', 'acronym': 'BCOMS', 'briefTitle': 'Black Cohosh Extract for Treatment of Moderate to Severe Menopausal Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Navamindradhiraj University'}, 'officialTitle': 'Black Cohosh Extract for the Treatment of Moderate to Severe Menopausal Symptoms: a Randomized-placebo Controlled Trial', 'orgStudyIdInfo': {'id': '081/56'}, 'secondaryIdInfos': [{'id': 'TCTR20140318001', 'type': 'REGISTRY', 'domain': 'Thai Clinical Trials Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Black cohosh extract', 'description': 'black cohosh extract 80 mg daily', 'interventionNames': ['Drug: black cohosh extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'black cohosh extract', 'type': 'DRUG', 'otherNames': ['Femosa'], 'description': 'Black cohosh extract 80 mg', 'armGroupLabels': ['Black cohosh extract']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Soy bean oil', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10300', 'city': 'Dusit', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Patsama Vichinsartvichai, MD', 'role': 'CONTACT', 'email': 'pat_si109@hotmail.com', 'phone': '+66877905656'}, {'name': 'Patsama Vichinsartvichai, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lookwai Kutheerawong, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Obstetrics and Gynecology, Faculty of Medicine Vajira Hospital, Navamindradhiraj University', 'geoPoint': {'lat': 13.7775, 'lon': 100.51977}}], 'centralContacts': [{'name': 'Patsama Vichinsartvichai, MD.', 'role': 'CONTACT', 'email': 'pat_si109@hotmail.com', 'phone': '+66877905656'}, {'name': 'Lookwai Kutheerawong, MD.', 'role': 'CONTACT', 'email': 'lookwaik@yahoo.com', 'phone': '+66820886464'}], 'overallOfficials': [{'name': 'Patsama Vichinsartvichai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine Vajira Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Navamindradhiraj University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD.', 'investigatorFullName': 'Patsama Vichinsartvichai', 'investigatorAffiliation': 'Navamindradhiraj University'}}}}