We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Herbal Galactogogues in Breastfeeding Mothers (Galactogogue)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02740751
Recruitment Status : Unknown
Verified April 2016 by Dilek Dilli, Dr. Sami Ulus Children's Hospital.
Recruitment status was:  Recruiting
First Posted : April 15, 2016
Last Update Posted : April 18, 2016
Sponsor:
Information provided by (Responsible Party):
Dilek Dilli, Dr. Sami Ulus Children's Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Weight Gain Dietary Supplement: Still-Tee Not Applicable

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Efficacy of Herbal Galactogogues on Weight Gain of the Newborns Within the First Month of Life in Breastfeeding Mothers
Study Start Date : April 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Still-Tee
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
 Dietary Supplement: Still-Tee
The mothers of the babies will receive Still-Tee galactogogue tea
Placebo Comparator: Placebo
The mothers of the babies will receive placebo tea which does not contain galactogogue herbs
 Dietary Supplement: Still-Tee
The mothers of the babies will receive Still-Tee galactogogue tea
No Intervention: Water
The mothers of the babies will receive water


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Weight gain [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Breast milk volume [ Time Frame: 4 weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Days to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02740751


Contacts
Layout table for location contacts
Contact: Dilek Dilli, Assoc Prof 0903056310 ext 6310 dilekdilli2@yahoo.com

Locations
Layout table for location information
Turkey
Dr Sami Ulus Children Hospital Recruiting
Ankara, Turkey, 06120
Contact: Dilek Dilli, Assoc prof    00903123056000 ext 6310    dilekdilli2@yahoo.com   
Sub-Investigator: Selcan Yılmaz, MD         
Sponsors and Collaborators
Dr. Sami Ulus Children's Hospital
Investigators
Layout table for investigator information
Study Director: Dilek Dilli, Assoc Prof Dr Sami Ulus Research and Training Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Dilek Dilli, MD, Assoc Prof, Dr. Sami Ulus Children's Hospital
ClinicalTrials.gov Identifier: NCT02740751    
Other Study ID Numbers: SamiUlusCH-trials-stilltee
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: April 18, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Weight Gain
Body Weight Changes
Body Weight