Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-01-03 @ 2:24 AM
Study NCT ID:
NCT02740751
Status:
UNKNOWN
Last Update Posted:
2016-04-18
First Post:
2016-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Herbal Galactogogues in Breastfeeding Mothers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015430', 'term': 'Weight Gain'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-15', 'studyFirstSubmitDate': '2016-04-12', 'studyFirstSubmitQcDate': '2016-04-12', 'lastUpdatePostDateStruct': {'date': '2016-04-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight gain', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Breast milk volume', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Weight Gain']}, 'referencesModule': {'references': [{'pmid': '32421208', 'type': 'DERIVED', 'citation': 'Foong SC, Tan ML, Foong WC, Marasco LA, Ho JJ, Ong JH. Oral galactagogues (natural therapies or drugs) for increasing breast milk production in mothers of non-hospitalised term infants. Cochrane Database Syst Rev. 2020 May 18;5(5):CD011505. doi: 10.1002/14651858.CD011505.pub2.'}]}, 'descriptionModule': {'briefSummary': 'Herbal teas with galactogoge effects have been used extensively in recent years in order to increase the amount of breast milk in lactating mothers. We also investigated whether a sleep-induced herbal tea (Still-Tee; Mamsel®) was effective in regulating the sleep of these mothers. Plain water was used as placebo.', 'detailedDescription': 'Herbal teas with galactogoge effects have been used extensively in recent years in order to increase the amount of breast milk in lactating mothers. Mothers of premature babies often have problems in breastfeeding and this study was designed to investigate if such herbal teas has any effect on the increasing of breast milk in mothers of premature babies. We also investigated whether a sleep-induced herbal tea (Still-Tee; Mamsel®) was effective in regulating the sleep of these mothers. Plain water was used as placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Days', 'minimumAge': '3 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Babies with gestational age of 35-42 weeks\n* Breasfed babies\n* Lactating mothers\n* Babies admitted to outpatient clinics of neonatology within the the first week of life\n\nExclusion Criteria:\n\n* Babies with gestational age of \\<35 weeks\n* Not breast feeding mothers\n* Babies admitted to outpatient clinics of neonatology within the the first week of life'}, 'identificationModule': {'nctId': 'NCT02740751', 'acronym': 'Galactogogue', 'briefTitle': 'Efficacy of Herbal Galactogogues in Breastfeeding Mothers', 'organization': {'class': 'OTHER', 'fullName': "Dr. Sami Ulus Children's Hospital"}, 'officialTitle': 'Efficacy of Herbal Galactogogues on Weight Gain of the Newborns Within the First Month of Life in Breastfeeding Mothers', 'orgStudyIdInfo': {'id': 'SamiUlusCH-trials-stilltee'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Still-Tee', 'description': 'Generic name: galactogoe herbal tee, still-tee Dosage: Three cups (each 200 ml) of tea of Still-Tee galactogogue tea will be used Frequency: Three times in a day Duration: for 4 weeks after birth', 'interventionNames': ['Dietary Supplement: Still-Tee']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The mothers of the babies will receive placebo tea which does not contain galactogogue herbs', 'interventionNames': ['Dietary Supplement: Still-Tee']}, {'type': 'NO_INTERVENTION', 'label': 'Water', 'description': 'The mothers of the babies will receive water'}], 'interventions': [{'name': 'Still-Tee', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The mothers of the babies will receive Still-Tee galactogogue tea', 'armGroupLabels': ['Placebo', 'Still-Tee']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06120', 'city': 'Ankara', 'state': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Dilek Dilli, Assoc prof', 'role': 'CONTACT', 'email': 'dilekdilli2@yahoo.com', 'phone': '00903123056000', 'phoneExt': '6310'}, {'name': 'Selcan Yılmaz, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Dr Sami Ulus Children Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Dilek Dilli, Assoc Prof', 'role': 'CONTACT', 'email': 'dilekdilli2@yahoo.com', 'phone': '0903056310', 'phoneExt': '6310'}], 'overallOfficials': [{'name': 'Dilek Dilli, Assoc Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dr Sami Ulus Research and Training Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Dr. Sami Ulus Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Assoc Prof', 'investigatorFullName': 'Dilek Dilli', 'investigatorAffiliation': "Dr. Sami Ulus Children's Hospital"}}}}