Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT01487694
Status:
UNKNOWN
Last Update Posted:
2011-12-29
First Post:
2011-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Black Cohosh Extract for the Management of Moderate to Severe Menopausal Symptoms in Thai Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019584', 'term': 'Hot Flashes'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 54}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-12-24', 'studyFirstSubmitDate': '2011-12-05', 'studyFirstSubmitQcDate': '2011-12-05', 'lastUpdatePostDateStruct': {'date': '2011-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean differences of Kupperman index', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Frequencies of menopausal symptoms', 'timeFrame': '12 weeks'}, {'measure': 'Compliance', 'timeFrame': '12 weeks'}, {'measure': 'adverse events', 'timeFrame': '12 weeks'}, {'measure': 'Mean differences of liver function test', 'timeFrame': '12 weeks'}, {'measure': 'quality of life', 'timeFrame': '12 weeks', 'description': 'Thai MENQOL measurement'}, {'measure': 'Overall satisfaction', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['back cohosh', 'cimicifuga racemosa', 'menopausal symptoms', 'hot flashes', 'Kupperman index', 'MENQOL'], 'conditions': ['Hot Flashes']}, 'descriptionModule': {'briefSummary': 'Cimicifuga racemosa (black cohosh) rhizome and root extract have been used to treat menopausal symptoms. To date, there are still scarce information about its efficacy in Thai women with menopausal symptoms. The purpose of this study will assess the efficacy of black cohosh extract in management of menopausal symptoms in Thai women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Thai women, aged ≥ 40 years\n* Peri- or postmenopause\n* Moderate to severe menopausal symptoms from Kupperman menopausal index score at least 20\n\nExclusion Criteria:\n\n* Using any drugs or hormonal treatment within 1 month before enrollment\n* BMI ≥ 30 kg/m2\n* Allergic to drugs or any ingredient\n* Liver disease or AST ≥ 37 U/L or ALT ≥ 40 U/L or total bilirubin ≥ 1 mg/dL or direct bilirubin ≥ 0.3 mg/dL\n* Psychiatric disease\n* Alcohol consumption or any elicit drug use\n* Vegetarian (may consume more phytoestrogen)'}, 'identificationModule': {'nctId': 'NCT01487694', 'briefTitle': 'Black Cohosh Extract for the Management of Moderate to Severe Menopausal Symptoms in Thai Women', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Cimicifuga Racemosa Rhizome and Root Extract for the Management of Moderate to Severe Menopausal Symptoms in Thai Women: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Si573/2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cimicifuga racemosa', 'description': 'patients receive cimicifuga racemosa rhizome and root extract 40 mg/day (equivalent to triterpene glycosides 12.3 mg)', 'interventionNames': ['Drug: cimicifuga racemosa']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo containing no active ingredient which match the drug in bottle, shape, color and smell', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'cimicifuga racemosa', 'type': 'DRUG', 'description': 'Cimicifuga racemosa (black cohosh) rhizome and root extract 40 mg once daily for 12 weeks (equivalent to triterpene glycosides 12.3 mg)', 'armGroupLabels': ['Cimicifuga racemosa']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'matching placebo without active ingredient 1 tab daily for 12 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkoknoi', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Prasong Tanmahasamut, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Patsama Vichinsartvichai, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gynecologic Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University'}], 'centralContacts': [{'name': 'Patsama Vichinsartvichai, MD', 'role': 'CONTACT', 'email': 'pat_si109@hotmail.com', 'phone': '664194657-8'}], 'overallOfficials': [{'name': 'Patsama Vichinsartvichai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynecologic Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}