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Efficacy of Herbal Galactogogues in Breastfeeding Mothers (Galactogogue)

Primary Purpose

Weight Gain

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Still-Tee
Sponsored by
Dr. Sami Ulus Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Weight Gain

Eligibility Criteria

3 Days - 30 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Dr Sami Ulus Children HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Arm Label

Still-Tee

Placebo

Water

Arm 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

The mothers of the babies will receive placebo tea which does not contain galactogogue herbs

The mothers of the babies will receive water

Outcomes

Primary Outcome Measures

Weight gain

Secondary Outcome Measures

Breast milk volume

Full Information

First Posted
April 12, 2016
Last Updated
April 15, 2016
Sponsor
Dr. Sami Ulus Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02740751
Brief Title
Efficacy of Herbal Galactogogues in Breastfeeding Mothers
Acronym
Galactogogue
Official Title
Efficacy of Herbal Galactogogues on Weight Gain of the Newborns Within the First Month of Life in Breastfeeding Mothers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Sami Ulus Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Still-Tee
Arm Type
Active Comparator
Arm 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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The mothers of the babies will receive placebo tea which does not contain galactogogue herbs
Arm Title
Water
Arm Type
No Intervention
Arm Description
The mothers of the babies will receive water
Intervention Type
Dietary Supplement
Intervention Name(s)
Still-Tee
Intervention Description
The mothers of the babies will receive Still-Tee galactogogue tea
Primary Outcome Measure Information:
Title
Weight gain
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Breast milk volume
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Days
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dilek Dilli, Assoc Prof
Phone
0903056310
Ext
6310
Email
dilekdilli2@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilek Dilli, Assoc Prof
Organizational Affiliation
Dr Sami Ulus Research and Training Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Dr Sami Ulus Children Hospital
City
Ankara
ZIP/Postal Code
06120
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dilek Dilli, Assoc prof
Phone
00903123056000
Ext
6310
Email
dilekdilli2@yahoo.com
First Name & Middle Initial & Last Name & Degree
Selcan Yılmaz, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32421208
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.
Results Reference
derived

Learn more about this trial

Efficacy of Herbal Galactogogues in Breastfeeding Mothers

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