Efficacy of Herbal Galactogogues in Breastfeeding Mothers (Galactogogue)

April 15, 2016 updated by: Dilek Dilli, Dr. Sami Ulus Children's Hospital

Efficacy of Herbal Galactogogues on Weight Gain of the Newborns Within the First Month of Life in Breastfeeding Mothers

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06120
        • Recruiting
        • Dr Sami Ulus Children Hospital
        • Contact:
        • Sub-Investigator:
          • Selcan Yılmaz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 days to 4 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight gain
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Breast milk volume
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Sami Ulus Children's Hospital

Investigators

  • Study Director: Dilek Dilli, Assoc Prof, Dr Sami Ulus Research and Training Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

April 12, 2016

First Submitted That Met QC Criteria

April 12, 2016

First Posted (Estimate)

April 15, 2016

Study Record Updates

Last Update Posted (Estimate)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SamiUlusCH-trials-stilltee

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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