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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02233439
Recruitment Status : Unknown
Verified September 2014 by Antonella Cromi, Università degli Studi dell'Insubria.
Recruitment status was:  Not yet recruiting
First Posted : September 8, 2014
Last Update Posted : September 8, 2014
Sponsor:
Collaborator:
Milte Italia SpA
Information provided by (Responsible Party):
Antonella Cromi, Università degli Studi dell'Insubria

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breastfeeding Dietary Supplement: Herbal galactagogue Dietary Supplement: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Herbal Galactogogues: a Double-blinded, Placebo-controlled Randomized Trial.
Study Start Date : September 2014
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
a placebo identical in appearance to the galactagogue product
 Dietary Supplement: Placebo
No Intervention: No treatment
Usual care and breastfeeding support
Experimental: 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
 Dietary Supplement: Herbal galactagogue
Other Name: Piùlatte® Plus (MILTE ITALIA SpA)


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of mothers who exclusively breastfeed their child [ Time Frame: At 6 weeks postpartum ]

Secondary Outcome Measures :
  1. Rate of breastfeeding (either exclusively or as a supplement to formula feeding ) [ Time Frame: at 6 weeks and 3 months ]
  2. Volume (mL) and frequency (times a day) of formula [ Time Frame: 6 weeks postpartum ]
  3. weight gain experienced by the newborns [ Time Frame: 6 weeks postpartum ]
  4. serum prolactin level [ Time Frame: at baseline and 6 weeks after treatment ]
  5. Rate of maternal allergic reactions and gastrointestinal side effects [ Time Frame: 6 weeks postpartum ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Neonatal Intensive Care Unit admission
  • use of galactagogue drugs
  • allergy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02233439


Contacts
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Contact: Antonella Cromi, MD antonella.cromi@uninsubria.it

Locations
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Italy
Azienda Ospedaliero-Universitaria Ospedale di Circolo e Fondazione Macchi, Presidio F. Del Ponte
Varese, Italy, 21100
Principal Investigator: Antonella Cromi, MD         
Sponsors and Collaborators
Università degli Studi dell'Insubria
Milte Italia SpA
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Antonella Cromi, Associate professor, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT02233439    
Other Study ID Numbers: IRB 54/2013
First Posted: September 8, 2014    Key Record Dates
Last Update Posted: September 8, 2014
Last Verified: September 2014
Keywords provided by Antonella Cromi, Università degli Studi dell'Insubria:
galactagogues
herbs
breastfeeding
 supplements
Silybum marianum
Galega officinalis
Additional relevant MeSH terms:
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Galactogogues
Physiological Effects of Drugs