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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02233439
Other study ID # IRB 54/2013
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 29, 2014
Last updated September 5, 2014
Start date September 2014
Est. completion date March 2015

Study information

Verified date September 2014
Source Università degli Studi dell'Insubria
Contact Antonella Cromi, MD
Email antonella.cromi@uninsubria.it
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 210
Est. completion date March 2015
Est. primary completion date January 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

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


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Herbal galactagogue

Placebo


Locations

Country Name City State
Italy Azienda Ospedaliero-Universitaria Ospedale di Circolo e Fondazione Macchi, Presidio F. Del Ponte Varese

Sponsors (2)

Lead Sponsor Collaborator
Università degli Studi dell'Insubria Milte Italia SpA

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of mothers who exclusively breastfeed their child At 6 weeks postpartum No
Secondary Rate of breastfeeding (either exclusively or as a supplement to formula feeding ) at 6 weeks and 3 months No
Secondary Volume (mL) and frequency (times a day) of formula 6 weeks postpartum No
Secondary weight gain experienced by the newborns 6 weeks postpartum No
Secondary serum prolactin level at baseline and 6 weeks after treatment No
Secondary Rate of maternal allergic reactions and gastrointestinal side effects 6 weeks postpartum Yes
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