BreastfeedingNCT02233439
Double-blind, Placebocontrolled A Randomized Trial on the Efficacy of Herbal Galactogogues
A study testing Herbal galactagogue in people with Breastfeeding, run by Università degli Studi dell'Insubria at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Herbal galactagogue
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- singleton, term delivery
- >2.5 kg newborn weight
- lactation-deficiency
Who cannot join
- Neonatal Intensive Care Unit admission
- use of galactagogue drugs
- allergy
Trial locations and contacts
1 site in 1 country.
Antonella Cromi, MD contact
Italy1 site
Azienda Ospedaliero-Universitaria Ospedale di Circolo e Fondazione Macchi, Presidio F. Del Ponte
Varese, 21100
Antonella Cromi, MD
About this study
Official title: Efficacy of Herbal Galactogogues: a Double-blinded, Placebo-controlled Randomized Trial.
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.
- Conditions
- Breastfeeding
- Being tested
- Herbal galactagogue, Placebo
- Keywords
- galactagogues, herbs, breastfeeding, supplements, Silybum marianum, Galega officinalis
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal galactagogueDietary supplement
Also called Piùlatte® Plus (MILTE ITALIA SpA)
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | a placebo identical in appearance to the galactagogue product Receives: 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 Receives: Dietary Supplement: Herbal galactagogue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of mothers who exclusively breastfeed their child
Measured: At 6 weeks postpartum
Secondary outcomes (5)
Rate of breastfeeding (either exclusively or as a supplement to formula feeding )
Measured: at 6 weeks and 3 months
Volume (mL) and frequency (times a day) of formula
Measured: 6 weeks postpartum
weight gain experienced by the newborns
Measured: 6 weeks postpartum
serum prolactin level
Measured: at baseline and 6 weeks after treatment
Rate of maternal allergic reactions and gastrointestinal side effects
Measured: 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Collaborators
- Milte Italia SpA
- Responsible party
- Principal investigator, Antonella Cromi, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233439
- Sponsor's protocol ID
- IRB 54/2013
- Status last verified
- Sep 2014
- First submitted
- 29 Aug 2014
- Last updated
- 8 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32421208
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Herbal Galactogogues: a Double-blinded, Placebo-controlled Randomized Trial.
- ClinicalTrials.gov ID
- NCT02233439
- Acronym / sponsor ID
- IRB 54/2013
- Conditions
- Breastfeeding
- Keywords
- galactagogues, herbs, breastfeeding, supplements, Silybum marianum, Galega officinalis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Collaborators
- Milte Italia SpA
- Study start
- Sep 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 8 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placeboa placebo identical in appearance to the galactagogue product |
| No treatment | No intervention | –Usual care and breastfeeding support |
| Herbal galactagogue | Experimental | Dietary Supplement: Herbal galactagogueA commercially available product containing a combination of Silybum marianum 400 mg and Galega officinalis 150 mg, once a day for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- singleton, term delivery
- >2.5 kg newborn weight
- lactation-deficiency
Key exclusion criteria (3 listed)
- Neonatal Intensive Care Unit admission
- use of galactagogue drugs
- allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herbal galactagogueAlso: Piùlatte® Plus (MILTE ITALIA SpA) | Dietary supplement | Herbal galactagogue |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Percentage of mothers who exclusively breastfeed their child
Time frame: At 6 weeks postpartum
5 secondary outcomes
Rate of breastfeeding (either exclusively or as a supplement to formula feeding )
Time frame: at 6 weeks and 3 months
Volume (mL) and frequency (times a day) of formula
Time frame: 6 weeks postpartum
weight gain experienced by the newborns
Time frame: 6 weeks postpartum
serum prolactin level
Time frame: at baseline and 6 weeks after treatment
Rate of maternal allergic reactions and gastrointestinal side effects
Time frame: 6 weeks postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2014.
- Derived from this study: PubMed 32421208Foong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonella Cromi, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Herbal galactagogue in people with Breastfeeding, run by Università degli Studi dell'Insubria at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonella Cromi, MD (antonella.cromi@uninsubria.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of mothers who exclusively breastfeed their child (time frame: At 6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02233439, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2014.