Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-25 @ 2:00 PM
Study NCT ID:
NCT00284492
Status:
COMPLETED
Last Update Posted:
2012-05-14
First Post:
2006-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acupuncture for Hot Flushes in Menopause
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': 'D012648', 'term': 'Self Care'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 286}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-11', 'studyFirstSubmitDate': '2006-01-30', 'studyFirstSubmitQcDate': '2006-01-30', 'lastUpdatePostDateStruct': {'date': '2012-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of hot flushes', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': "Health related quality of life (Women's Health Questionnaire)", 'timeFrame': '12 weeks'}]}, 'conditionsModule': {'keywords': ['Women', 'Acupuncture', 'Menopause', 'Hot flashes', 'Health related quality of life'], 'conditions': ['Menopause', 'Hot Flashes']}, 'descriptionModule': {'briefSummary': 'In a pragmatic study investigate whether Traditional Chinese Medicine acupuncture-care decreases the frequency of hot flushes and increases health related quality of life among postmenopausal women. The intervention group will receive 10 sessions of acupuncture, the control group will engage in self care only. The study period lasts for 12 weeks.', 'detailedDescription': 'The study objective is to determine whether Traditional Chinese Medicine (TCM) acupuncture-care together with self-care is more effective than self-care alone, to relieve climacteric complaints among women who seek alternatives to hormonal replacement therapy (HRT). Study design is a pragmatic randomised controlled trial with two parallel arms. Study participants are postmenopausal women who document a mean value of 7 flushes/24 hours and who are not using HRT or other prescribed medication that may influence climacteric complaints. The treatment group will receive 10 sessions of TCM acupuncture-care and self-care; the control group will engage in self-care only.\n\nThe duration of intervention period is 12 weeks with evaluations at baseline, 4, 8, 12 weeks, and follow up at 6 and 12 months after baseline. Primary endpoint is change in daily hot flush frequency in the two groups from baseline to 12 weeks; secondary endpoint is health related quality of life. N in each treatment group: 143 (286 altogether).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Postmenopausal women (at least one year past the last menstrual period) who are willing to receive acupuncture and who during two weeks of self-completed diaries10 document a mean value of 7 flushes/24 hours or more (or 50 flushes or more over a period of seven consecutive days), will be randomized after a baseline evaluation.\n* Current users prescribed medications that influence hot flush rate (e. g. HRT, SSRI's) can be included after a washout period. The washout-periods are eight weeks for SSRI's and systemic (including transdermal) HRT and four weeks for local estradiol preparations\n\nExclusion Criteria:\n\n* Surgical menopause\n* History of cancer within the past five years\n* Use of anticoagulant drugs\n* Heart valve disease\n* Poorly controlled hypertension\n* Hypothyroidism\n* Hyperthyroidism or diabetes mellitus\n* Organ transplant\n* Mental disease\n* Overt drug or alcohol dependency\n* Inability to complete study forms"}, 'identificationModule': {'nctId': 'NCT00284492', 'acronym': 'ACUFLASH', 'briefTitle': 'Acupuncture for Hot Flushes in Menopause', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of North Norway'}, 'officialTitle': 'Effectiveness of Acupuncture-care for Treatment of Hot Flushes Among Postmenopausal Women', 'orgStudyIdInfo': {'id': 'P REK NORD 102/2005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lifestyle advice', 'interventionNames': ['Behavioral: Self Care']}, {'type': 'EXPERIMENTAL', 'label': 'Lifestyle advice and acupuncture therapy', 'interventionNames': ['Procedure: Traditional chinese medicine type acupuncture']}], 'interventions': [{'name': 'Traditional chinese medicine type acupuncture', 'type': 'PROCEDURE', 'description': '10 acupuncture sessions', 'armGroupLabels': ['Lifestyle advice and acupuncture therapy']}, {'name': 'Self Care', 'type': 'BEHAVIORAL', 'description': 'Lifestyle advice on diet, physical activity', 'armGroupLabels': ['Lifestyle advice']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'No-9038', 'city': 'Tromsø', 'country': 'Norway', 'facility': 'Clinical Research Center, University Hospital of North Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}], 'overallOfficials': [{'name': 'Sameline Grimsgaard, MD, MPH, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of North Norway. No-9038 Tromsø, Norway'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of North Norway', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Research Council of Norway', 'class': 'OTHER'}, {'name': 'University of Tromso', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}