Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-01-04 @ 6:47 PM
Study NCT ID:
NCT03230760
Status:
UNKNOWN
Last Update Posted:
2017-08-02
First Post:
2017-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture for Breast Engorgement During Lactation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2018-06-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-01', 'studyFirstSubmitDate': '2017-07-24', 'studyFirstSubmitQcDate': '2017-07-25', 'lastUpdatePostDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'breast engorgement', 'timeFrame': '3 days', 'description': 'Six-point Engorgement Scale'}], 'secondaryOutcomes': [{'measure': 'mastitis', 'timeFrame': '3 days', 'description': 'The incidence of mastitis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acupuncture', 'breast engorgement', 'lactation'], 'conditions': ['Breast Engorgement']}, 'referencesModule': {'references': [{'pmid': '27351423', 'type': 'RESULT', 'citation': 'Mangesi L, Zakarija-Grkovic I. Treatments for breast engorgement during lactation. Cochrane Database Syst Rev. 2016 Jun 28;2016(6):CD006946. doi: 10.1002/14651858.CD006946.pub3.'}, {'pmid': '32987448', 'type': 'DERIVED', 'citation': 'Crepinsek MA, Taylor EA, Michener K, Stewart F. Interventions for preventing mastitis after childbirth. Cochrane Database Syst Rev. 2020 Sep 29;9(9):CD007239. doi: 10.1002/14651858.CD007239.pub4.'}, {'pmid': '32944940', 'type': 'DERIVED', 'citation': 'Zakarija-Grkovic I, Stewart F. Treatments for breast engorgement during lactation. Cochrane Database Syst Rev. 2020 Sep 18;9(9):CD006946. doi: 10.1002/14651858.CD006946.pub4.'}]}, 'descriptionModule': {'briefSummary': 'Breast engorgement which may manifest swell, throb, and cause mild to extreme pain is the common difficulty for breast feeding woman. It occurs in the mammary glands due to expansion and pressure exerted by the synthesis and storage of breast milk and it usually happens when the breasts switch from colostrums to mature milk. However, engorgement can also happen if lactating women miss several nursing and not enough milk is expressed from the breasts. It can be exacerbated by insufficient breastfeeding and/or blocked milk ducts. Engorgement may lead to mastitis and untreated engorgement puts pressure on the milk ducts, often causing a plugged duct.\n\nAccording the meridian theory, the investigators propose the acupuncture treatment for patients of breast engorgement.\n\nThe investigators will include 60 patients and measure the acupuncture effect. The inclusion criteria are women with breast engorgement and 20 years old or older. Exclusion standards are patients with: 1. diabetes mellitus 2. Psychological disease or mental illness 3. Fever \\> 38 degrees Celsius 4. Mastitis 5.analgetics or anti - inflammatory agents used 6. ultrasound therapy applied'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women with breast engorgement and 20 years old or older\n\nExclusion Criteria:\n\n* patients with:\n\n 1. diabetes mellitus\n 2. psychological disease or mental illness\n 3. Fever \\> 38 degrees Celsius\n 4. Mastitis\n 5. analgesics or anti - inflammatory agents used\n 6. ultrasound therapy applied'}, 'identificationModule': {'nctId': 'NCT03230760', 'briefTitle': 'Acupuncture for Breast Engorgement During Lactation', 'organization': {'class': 'OTHER', 'fullName': 'Taichung Veterans General Hospital'}, 'officialTitle': 'Acupuncture for Breast Engorgement During Lactation: a Pilot Study.', 'orgStudyIdInfo': {'id': 'CF17141A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment', 'interventionNames': ['Device: acupuncture']}], 'interventions': [{'name': 'acupuncture', 'type': 'DEVICE', 'description': 'Device: acupuncture Acupuncture is the treatment which balances qi and blood by inserting needles into the acupoints of the meridians in human body.', 'armGroupLabels': ['treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '407', 'city': 'Taichung', 'status': 'NOT_YET_RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'PeiJung Chiang', 'role': 'CONTACT', 'email': 'aerin.chiang@gmail.com', 'phone': '886963826707'}], 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '407', 'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'PeiJung Chiang', 'role': 'CONTACT', 'phone': '886963826707'}], 'facility': 'TCM', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'ShuHuey Chou', 'role': 'CONTACT', 'email': 'lummdo@gmail.com', 'phone': '886963826707'}], 'overallOfficials': [{'name': 'PeiJung Chiang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Traditional Chinese Medicine department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'physician', 'investigatorFullName': 'PeiJung Chiang', 'investigatorAffiliation': 'Taichung Veterans General Hospital'}}}}