<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02233439</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 54/2013</org_study_id>
    <nct_id>NCT02233439</nct_id>
  </id_info>
  <brief_title>Double-blind, Placebocontrolled A Randomized Trial on the Efficacy of Herbal Galactogogues</brief_title>
  <official_title>Efficacy of Herbal Galactogogues: a Double-blinded, Placebo-controlled Randomized Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Università degli Studi dell'Insubria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Milte Italia SpA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Università degli Studi dell'Insubria</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the effectiveness of a commercially available product&#xD;
      containing a combination of Silybum marianum and Galega officinalis to support continuation&#xD;
      or augmentation of breast milk production.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">March 2015</completion_date>
  <primary_completion_date type="Anticipated">January 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of mothers who exclusively breastfeed their child</measure>
    <time_frame>At 6 weeks postpartum</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of breastfeeding (either exclusively or as a supplement to formula feeding )</measure>
    <time_frame>at 6 weeks and 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume (mL) and frequency (times a day) of formula</measure>
    <time_frame>6 weeks postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>weight gain experienced by the newborns</measure>
    <time_frame>6 weeks postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum prolactin level</measure>
    <time_frame>at baseline and 6 weeks after treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of maternal allergic reactions and gastrointestinal side effects</measure>
    <time_frame>6 weeks postpartum</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">210</enrollment>
  <condition>Breastfeeding</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>a placebo identical in appearance to the galactagogue product</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care and breastfeeding support</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Herbal galactagogue</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A commercially available product containing a combination of Silybum marianum 400 mg and Galega officinalis 150 mg, once a day for 6 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Herbal galactagogue</intervention_name>
    <arm_group_label>Herbal galactagogue</arm_group_label>
    <other_name>Piùlatte® Plus (MILTE ITALIA SpA)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  singleton, term delivery&#xD;
&#xD;
          -  &gt;2.5 kg newborn weight&#xD;
&#xD;
          -  lactation-deficiency&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neonatal Intensive Care Unit admission&#xD;
&#xD;
          -  use of galactagogue drugs&#xD;
&#xD;
          -  allergy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Antonella Cromi, MD</last_name>
    <email>antonella.cromi@uninsubria.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria Ospedale di Circolo e Fondazione Macchi, Presidio F. Del Ponte</name>
      <address>
        <city>Varese</city>
        <zip>21100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <investigator>
      <last_name>Antonella Cromi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>September 5, 2014</last_update_submitted>
  <last_update_submitted_qc>September 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Università degli Studi dell'Insubria</investigator_affiliation>
    <investigator_full_name>Antonella Cromi</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>galactagogues</keyword>
  <keyword>herbs</keyword>
  <keyword>breastfeeding</keyword>
  <keyword>supplements</keyword>
  <keyword>Silybum marianum</keyword>
  <keyword>Galega officinalis</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Galactogogues</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02233439
org study id: IRB 54/2013
nct id: NCT02233439
lead sponsor: 
collaborator: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Percentage of mothers who exclusively breastfeed their child
time frame: At 6 weeks postpartum
measure: Rate of breastfeeding (either exclusively or as a supplement to formula feeding )
time frame: at 6 weeks and 3 months
measure: Volume (mL) and frequency (times a day) of formula
time frame: 6 weeks postpartum
measure: weight gain experienced by the newborns
time frame: 6 weeks postpartum
measure: serum prolactin level
time frame: at baseline and 6 weeks after treatment
measure: Rate of maternal allergic reactions and gastrointestinal side effects
time frame: 6 weeks postpartum
arm group label: Placebo
arm group type: Placebo Comparator
description: a placebo identical in appearance to the galactagogue product
arm group label: No treatment
arm group type: No Intervention
description: Usual care and breastfeeding support
arm group label: Herbal galactagogue
arm group type: Experimental
description: A commercially available product containing a combination of Silybum marianum 400 mg and Galega officinalis 150 mg, once a day for 6 weeks
intervention type: Dietary Supplement
intervention name: Herbal galactagogue
arm group label: Herbal galactagogue
other name: Piùlatte® Plus (MILTE ITALIA SpA)
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Antonella Cromi, MD
email: antonella.cromi@uninsubria.it
facility: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Università degli Studi dell'Insubria
investigator full name: Antonella Cromi
investigator title: Associate professor
mesh term: Galactogogues