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

Breastfeeding Clinical Trial

Official title:

Efficacy of Herbal Galactogogues: a Double-blinded, Placebo-controlled Randomized Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02233439
• Other study ID #: IRB 54/2013
• 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

• Breastfeeding

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