Double-blind, Placebocontrolled A Randomized Trial on the Efficacy of Herbal Galactogogues
Not Applicable
- Conditions
- Breastfeeding
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Herbal galactagogue
- 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
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
- Arm && Interventions
Group Intervention Description Placebo Placebo a placebo identical in appearance to the galactagogue product Herbal galactagogue Herbal galactagogue A commercially available product containing a combination of Silybum marianum 400 mg and Galega officinalis 150 mg, once a day for 6 weeks
- 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