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

NCT ID: NCT02233439

Last Updated: 2014-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-03-31

Brief Summary

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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

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Conditions

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Breastfeeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Placebo

a placebo identical in appearance to the galactagogue product

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

No treatment

Usual care and breastfeeding support

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Herbal galactagogue

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Herbal galactagogue

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Piùlatte® Plus (MILTE ITALIA SpA)

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Neonatal Intensive Care Unit admission
* use of galactagogue drugs
* allergy
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Milte Italia SpA

UNKNOWN

Sponsor Role collaborator

Università degli Studi dell'Insubria

OTHER

Sponsor Role lead

Responsible Party

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Antonella Cromi

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda Ospedaliero-Universitaria Ospedale di Circolo e Fondazione Macchi, Presidio F. Del Ponte

Varese, , Italy

Site Status

Countries

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Italy

Central Contacts

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Antonella Cromi, MD

Role: CONTACT

References

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Foong SC, Tan ML, Foong WC, Marasco LA, Ho JJ, Ong JH. Oral galactagogues (natural therapies or drugs) for increasing breast milk production in mothers of non-hospitalised term infants. Cochrane Database Syst Rev. 2020 May 18;5(5):CD011505. doi: 10.1002/14651858.CD011505.pub2.

Reference Type DERIVED
PMID: 32421208 (View on PubMed)

Other Identifiers

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IRB 54/2013

Identifier Type: -

Identifier Source: org_study_id

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