Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2026-02-22 @ 7:04 AM
Study NCT ID:
NCT02580968
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2015-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Key Electro-acupuncture Technique on Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005444', 'term': 'Flunarizine'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-03', 'studyFirstSubmitDate': '2015-07-30', 'studyFirstSubmitQcDate': '2015-10-18', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Migraine Disability Assessment Questionnaire (MIDAS)', 'timeFrame': '20 days', 'description': 'a scientifically reliable and valid measure of migraine disability that can improve communication between patients and physicians, assess migraine severity and act as an outcome measure to monitor treatment efficacy'}], 'secondaryOutcomes': [{'measure': 'The medical outcomes study 36-item short-form health survey(SF-36)', 'timeFrame': '20 days', 'description': 'A 36-item short-form (SF-36) was constructed to survey health status in the Medical Outcomes Study'}, {'measure': 'peripheral Nitrogen Monoxide(NO) protein expression', 'timeFrame': '20 days', 'description': 'marker'}, {'measure': 'peripheral Calcitonin gene related peptide(CGRP) protein expression', 'timeFrame': '20 days', 'description': 'marker'}, {'measure': 'peripheral Nuclear factor-kappa B(NF-кB) protein expression', 'timeFrame': '20 days', 'description': 'marker'}, {'measure': 'Visual Analogue Scale (VAS) to assess pain', 'timeFrame': '20 days', 'description': 'Visual Analogue Scale (VAS) were applied to measure pain in patients'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Electroacupuncture therapy', 'Migraine', 'Acupuncture Therapy'], 'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': 'A random controlled trail to evaluate the efficacy of migraine standard electroacupuncture formula, and to analysis the regulation of the intensity-effects and to observe the peripheral NO, CGRP and NF-кB expression level of migraine patients after electroacupuncture treatment.', 'detailedDescription': 'acupuncture group(group A): treated by acupuncture for 20 days, 1 time per day control group(group B): treated by FlunarizineHydrochloride for 20 days, 1 table per day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* met the diagnostic criteria for migraine; suffering from migraine attacks; migraine attacks for more than 5 days per month, and lasts for 3 months; voluntarily join this study with informed consents.\n\nExclusion Criteria:\n\n* other systemic, neurological and psychiatric disorders; headache caused by other diseases; not treatment compliance during the study.'}, 'identificationModule': {'nctId': 'NCT02580968', 'briefTitle': 'Study of Key Electro-acupuncture Technique on Migraine', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai University of Traditional Chinese Medicine'}, 'officialTitle': 'Study of Key Electro-acupuncture Technique on Migraine', 'orgStudyIdInfo': {'id': '643857003534'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'electro-acupuncture', 'description': '100hz, 2min. electro-acupoint: LI4(Large Intestine4) with LV3(Liver3).5times a week. lasting for 4 weeks.', 'interventionNames': ['Device: electro-acupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'routin medicine', 'description': 'one tablet of flunarizine hydrochloride tablet per day. lasting for 20days', 'interventionNames': ['Drug: flunarizine hydrochloride']}], 'interventions': [{'name': 'electro-acupuncture', 'type': 'DEVICE', 'description': 'electro-acupuncture on acupoints according to the traditional syndrome diagnosis.once per day, for 20 days.', 'armGroupLabels': ['electro-acupuncture']}, {'name': 'flunarizine hydrochloride', 'type': 'DRUG', 'otherNames': ['flunarizine'], 'description': 'flunarizine hydrochloride ，10mg/day，for 20 days。', 'armGroupLabels': ['routin medicine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'country': 'China', 'facility': 'Longhua Hospital,Shanghai University of Traditional Chinese Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Jian Pei, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Longhua Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}