NCT02233439

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

September 8, 2014

Status Verified

September 1, 2014

Enrollment Period

4 months

First QC Date

August 29, 2014

Last Update Submit

September 5, 2014

Conditions

Breastfeeding

Keywords

galactagoguesherbsbreastfeedingsupplementsSilybum marianumGalega officinalis

Outcome Measures

Primary Outcomes (1)

  • Percentage of mothers who exclusively breastfeed their child

    At 6 weeks postpartum

Secondary Outcomes (5)

  • 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

a placebo identical in appearance to the galactagogue product

Dietary Supplement: Placebo

No treatment

NO INTERVENTION

Usual care and breastfeeding support

Herbal galactagogue

EXPERIMENTAL

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

Interventions

Herbal galactagogueDIETARY_SUPPLEMENT
Also known as: Piùlatte® Plus (MILTE ITALIA SpA)
Herbal galactagogue
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Neonatal Intensive Care Unit admission
  • use of galactagogue drugs
  • allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Varese, 21100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 32421208DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Central Study Contacts

Antonella Cromi, MD

CONTACT

antonella.cromi@uninsubria.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 29, 2014

First Posted

September 8, 2014

Study Start

September 1, 2014

Primary Completion

January 1, 2015

Study Completion

March 1, 2015

Last Updated

September 8, 2014

Record last verified: 2014-09

Locations

IT(1)