Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-31 @ 10:21 PM
Study NCT ID:
NCT01933204
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2013-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture for Relieving Perimenopausal Symptoms
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': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'C103294', 'term': 'estradiol valerate, cyproterone acetate drug combination'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-13', 'studyFirstSubmitDate': '2013-08-09', 'studyFirstSubmitQcDate': '2013-08-28', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Menopause Rating Scale', 'timeFrame': '12 weeks after randomization', 'description': 'The scale was developed and validated over the years from a research network of many institutions such as Organon Germany, Infratest Munich, Universities of Muenster and Berlin,the Berlin Center for Epidemiology and Health Research, etc. It is a scale consisted of 11 items, ranging from no symptoms to very severe symptoms.'}], 'secondaryOutcomes': [{'measure': 'Menopausal Specific Quality of Life Questionnaire', 'timeFrame': 'asessed 0, 6, 12, 24, 36 weeks after randomization', 'description': 'The Menopausal Specific Quality of Life Questionnaire (MENQOL) is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29).'}, {'measure': 'Average hot flash score during 24 hours', 'timeFrame': '0, 12, 24, 36 weeks after randomization'}, {'measure': 'Level of Estradiol in serum', 'timeFrame': '0, 12, 24 weeks after randomization'}, {'measure': 'Level of follicle stimulating hormone in serum', 'timeFrame': '0, 12, 24 weeks after randomization'}, {'measure': 'Level of luteinizing hormone in serum', 'timeFrame': '0, 12, 24 weeks after randomization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['perimenopause', 'hot flash', 'palpitation'], 'conditions': ['Perimenopause']}, 'referencesModule': {'references': [{'pmid': '24886348', 'type': 'DERIVED', 'citation': 'Li Y, Zheng H, Zheng Q, Zhao L, Qin E, Wang Y, Zeng Q, Zheng H, Zhao Y, Sun W, Zhang X, Liu Z, Liu B. Use acupuncture to relieve perimenopausal syndrome: study protocol of a randomized controlled trial. Trials. 2014 May 30;15:198. doi: 10.1186/1745-6215-15-198.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether acupuncture is effective for relieving perimenopausal symptoms.', 'detailedDescription': '* A randomised controlled trial with superiority design\n* A total of 220 participants will be included in 3 centers\n* 2 arms: acupuncture group and Climen® group'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days. At least 2 cycles were missing during the past 12 months, or reported menopause for at least 60 days.\n* Reported relative perimenopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.\n* Age 40-50 years.\n* Not accompanied with conditions that are needed for hormone therapy, e.g., menopause after surgery, active osteoporosis.\n* Willing to participate and signing the inform consent.\n\nExclusion Criteria:\n\n* Had a regular menopausal cycle 3 months before this trial.\n* Taking estrogen, selective serotonin reuptake inhibitor(SSRI), soy isoflavone, progesterone, Vitamin E or black cohosh in the 4 weeks before inclusion.\n* receiving chemoradiotherapy.\n* Agnogenic vaginal bleeding.\n* Coagulation defeats, or taking anticoagulant drugs, such as warfarin, heparin, etc.\n* Dermal diseases, e.g., eczema, psoriasis.\n* Liver or kidney failure.\n* Uncontrollable hypertension, diabetes, or thyroid diseases.\n* With diabetic neuropathy, malignant cancer and mental diseases (including depression).\n* Intend to gestation, in gestation period or lactation period.\n* Using sedative or antianxiety drugs.\n* With smoking or intemperance problems.\n* Using cardiac pacemaker, or joint prosthesis.\n* Low compliance.\n* Benign tumor in breast.\n* Family history of breast cancer.'}, 'identificationModule': {'nctId': 'NCT01933204', 'briefTitle': 'Acupuncture for Relieving Perimenopausal Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Chengdu University of Traditional Chinese Medicine'}, 'officialTitle': 'Acupuncture for Relieving Perimenopausal Symptoms: a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '2012BAI24B01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupuncture', 'description': 'Using basic points combined with additional points. Basic points are fixed, while additional points will be selected from a list of points categorized by syndrome differentiation.', 'interventionNames': ['Other: Acupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Climen 21 Tablets', 'description': 'COMPOSITION 11 white tablets each containing estradiol-17-valerate 2 mg, plus 10 pink tablets each containing estradiol-17-valerate 2 mg and cyproterone acetate 1 mg.', 'interventionNames': ['Drug: Climen 21 Tablets']}], 'interventions': [{'name': 'Acupuncture', 'type': 'OTHER', 'description': 'Acupuncture is a collection of procedures involving penetration of the skin with needles to stimulate certain points on the body. In its classical form it is a characteristic component of traditional Chinese medicine (TCM), a form of alternative medicine, and one of the oldest healing practices in the world.', 'armGroupLabels': ['Acupuncture']}, {'name': 'Climen 21 Tablets', 'type': 'DRUG', 'otherNames': ['Climen Tablets'], 'description': 'Climen Tablets are commonly used for menopausal symptoms', 'armGroupLabels': ['Climen 21 Tablets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610075', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Chengdu University of Traditional Chinese Medicine', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '610075', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'First affiliated hospital of Chengdu University of TCM', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'overallOfficials': [{'name': 'Ying Li, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chengdu University of Traditional Chinese Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chengdu University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': "Chengdu First People's Hospital", 'class': 'OTHER'}, {'name': 'Chengdu PLA General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}