Breastfeeding
Conditions
Keywords
galactagogues, herbs, breastfeeding, supplements, Silybum marianum, Galega officinalis
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.
Interventions
DIETARY_SUPPLEMENTHerbal galactagogue
DIETARY_SUPPLEMENTPlacebo
Sponsors
Milte Italia SpA
Università degli Studi dell'Insubria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* singleton, term delivery * \>2.5 kg newborn weight * lactation-deficiency
Exclusion criteria
* Neonatal Intensive Care Unit admission * use of galactagogue drugs * allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of mothers who exclusively breastfeed their child | At 6 weeks postpartum |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Italy
Contacts
Primary ContactAntonella Cromi, MD
Outcome results
None listed