Efficacy of Herbal Galactogogues in Breastfeeding Mothers

Weight Gain Clinical Trial

— Galactogogue  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02740751
• Other study ID #: SamiUlusCH-trials-stilltee
• Status: Recruiting
• Phase: N/A
• First received: April 12, 2016
• Last updated: April 15, 2016
• Start date: April 2016
• Est. completion date: April 2017

Study information

• Verified date: April 2016
• Source: Dr. Sami Ulus Children's Hospital
• Contact: Dilek Dilli, Assoc Prof
• Phone: 0903056310
• Email: dilekdilli2[@]yahoo.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 30 Days

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Weight Gain

Intervention

Dietary Supplement:
• Still-Tee
The mothers of the babies will receive Still-Tee galactogogue tea

Locations

Country	Name	City	State
Turkey	Dr Sami Ulus Children Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Sami Ulus Children's Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight gain		4 weeks	No
Secondary	Breast milk volume		4 weeks	No