Double-blind, Placebocontrolled A Randomized Trial on the Efficacy of Herbal Galactogogues

Not Applicable

• Conditions: Breastfeeding

• Registration Number: NCT02233439
• Lead Sponsor: Università degli Studi dell'Insubria

Brief Summary

The purpose of this study is to assess the effectiveness of a commercially available product containing a combination of Silybum marianum and Galega officinalis to support continuation or augmentation of breast milk production.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-29
• Status Verified: 2014-09
• Study Start: 2014-09
• Study First Submitted QC: 2014-09-05
• Last Update Submitted: 2014-09-05
• Study First Posted: 2014-09-08
• Last Update Posted: 2014-09-08
• Primary Completion: 2015-01
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 210

Inclusion Criteria

• singleton, term delivery
• >2.5 kg newborn weight
• lactation-deficiency

Exclusion Criteria

• Neonatal Intensive Care Unit admission
• use of galactagogue drugs
• allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of mothers who exclusively breastfeed their child	At 6 weeks postpartum

Secondary Outcome Measures

Name	Time	Method
Rate of breastfeeding (either exclusively or as a supplement to formula feeding )	at 6 weeks and 3 months
Volume (mL) and frequency (times a day) of formula	6 weeks postpartum
weight gain experienced by the newborns	6 weeks postpartum
serum prolactin level	at baseline and 6 weeks after treatment
Rate of maternal allergic reactions and gastrointestinal side effects	6 weeks postpartum

Trial Locations

Locations (1)

Azienda Ospedaliero-Universitaria Ospedale di Circolo e Fondazione Macchi, Presidio F. Del Ponte; 🇮🇹 Varese, Italy