Efficacy of Herbal Galactogogues in Breastfeeding Mothers
Galactogogue
1 other identifier
interventional
90
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 12, 2016
CompletedFirst Posted
Study publicly available on registry
April 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedApril 18, 2016
April 1, 2016
9 months
April 12, 2016
April 15, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Weight gain
4 weeks
Secondary Outcomes (1)
Breast milk volume
4 weeks
Study Arms (3)
Still-Tee
ACTIVE COMPARATORGeneric 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
Placebo
PLACEBO COMPARATORThe mothers of the babies will receive placebo tea which does not contain galactogogue herbs
Water
NO INTERVENTIONThe mothers of the babies will receive water
Interventions
The mothers of the babies will receive Still-Tee galactogogue tea
Eligibility Criteria
You may qualify if:
- Babies with gestational age of 35-42 weeks
- Breasfed babies
- Lactating mothers
- Babies admitted to outpatient clinics of neonatology within the the first week of life
You may not qualify if:
- Babies with gestational age of \<35 weeks
- Not breast feeding mothers
- Babies admitted to outpatient clinics of neonatology within the the first week of life
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr Sami Ulus Children Hospital
Ankara, Ankara, 06120, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 32421208DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dilek Dilli, Assoc Prof
Dr Sami Ulus Research and Training Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Assoc Prof
Study Record Dates
First Submitted
April 12, 2016
First Posted
April 15, 2016
Study Start
April 1, 2016
Primary Completion
January 1, 2017
Study Completion
April 1, 2017
Last Updated
April 18, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will not share