Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-28 @ 11:24 PM
Study NCT ID:
NCT00120458
Status:
COMPLETED
Last Update Posted:
2010-03-02
First Post:
2005-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Black Cohosh as Alternative Therapy for Treating Menopause-Related Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713173', 'term': 'black cohosh root extract'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-01', 'studyFirstSubmitDate': '2005-07-14', 'studyFirstSubmitQcDate': '2005-07-14', 'lastUpdatePostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score on Hamilton Anxiety Rating Scale', 'timeFrame': '12 Weeks'}], 'secondaryOutcomes': [{'measure': 'Quality of life and functional outcome ratings', 'timeFrame': '12 Weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Black Cohosh', 'Cimicifuga', 'Anxiety', 'Women', 'Complementary and Alternative Medicine'], 'conditions': ['Generalized Anxiety Disorder', 'Menopause']}, 'referencesModule': {'references': [{'pmid': '19745648', 'type': 'DERIVED', 'citation': 'Amsterdam JD, Yao Y, Mao JJ, Soeller I, Rockwell K, Shults J. Randomized, double-blind, placebo-controlled trial of Cimicifuga racemosa (black cohosh) in women with anxiety disorder due to menopause. J Clin Psychopharmacol. 2009 Oct;29(5):478-83. doi: 10.1097/JCP.0b013e3181b2abf2.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine the effectiveness of the herb black cohosh for treating menopause-related anxiety symptoms in women.\n\nStudy hypotheses: 1) Black cohosh will have a superior anti-anxiety effect compared to placebo. 2) Black cohosh will have a comparable safety profile to that of placebo.', 'detailedDescription': "During menopause, up to 90% of women will experience symptoms of anxiety, such as nervousness, irritability, fatigue, muscle aches, depression, and low libido. Concern over the safety and effectiveness of hormone replacement therapy for relieving these symptoms has caused many women to seek alternative medical treatments. Data suggest that black cohosh has a direct effect on the neurotransmitters and receptors involved in anxiety. This study will determine whether black cohosh can effectively treat anxiety symptoms in menopausal women.\n\nThis study will last 12 weeks. Participants will be randomly assigned to receive either black cohosh or placebo daily for the duration of the study. Self-report scales will be used to assess participants' anxiety symptoms and quality of life at the beginning and end of the study."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently experiencing menopause or postmenopausal\n* Have symptoms of menopause-related anxiety\n\nExclusion Criteria:\n\n* Any form of generalized anxiety disorder (GAD) unrelated to menopause\n* Onset of GAD at least 3 years prior to menopause or at least 5 years after menstruation has stopped\n* Alcohol or drug dependence within 3 months prior to study entry\n* Allergy to black cohosh\n* History of hormone replacement therapy\n* Current use of vaginal estrogen cream or phytoestrogens\n* Current use of tranquilizers, antidepressants, or antianxiety therapies\n* Abnormal uterine bleeding\n* History of estrogen-dependent cancer\n* History of endometrial hyperplasia (abnormal increase in cells) or endometrial cancer\n* Rapidly growing uterine fibroids\n* Abnormal finding upon gynecological examination that would interfere with the study\n* Abnormal breast examination or mammogram\n* Any unstable medical condition'}, 'identificationModule': {'nctId': 'NCT00120458', 'briefTitle': 'Black Cohosh as Alternative Therapy for Treating Menopause-Related Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Black Cohosh Therapy for Menopause-Related Anxiety', 'orgStudyIdInfo': {'id': 'R21AT002289-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R21AT002289-01A1', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R21AT002289-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R21AT002289-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Anxiolytic Therapy', 'interventionNames': ['Dietary Supplement: Black cohosh']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Anxiolytic Therapy', 'interventionNames': ['Dietary Supplement: Black cohosh']}], 'interventions': [{'name': 'Black cohosh', 'type': 'DIETARY_SUPPLEMENT', 'description': '32 to 128 mg (black cohosh)\n\n1 to 4 capsules daily (placebo)', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104-3309', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Depression Research Unit, University of Pennsylvania School of Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Jay D. Amsterdam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}, {'name': 'Office of Dietary Supplements (ODS)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Jay D. Amsterdam, M.D.', 'oldOrganization': 'University of Pennsylvania'}}}}