<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/NCT02190448</url>
  </required_header>
  <id_info>
    <org_study_id>SLS2013</org_study_id>
    <nct_id>NCT02190448</nct_id>
  </id_info>
  <brief_title>Randomized, Placebo-Controlled Study of an Herbal Tea to Support Lactation</brief_title>
  <acronym>SLS</acronym>
  <official_title>A Randomized, Placebo-Controlled Study of an Herbal Tea to Support Lactation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Traditional Medicinals Corporation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of South Carolina</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall aims of this project are to 1) determine the quality of life effects of a&#xD;
      combination herbal galactagogue tea in lactating women, and 2) measure changes in maternal&#xD;
      blood concentration of oxytocin, prolactin, and milk production. The defined outcome measures&#xD;
      will include quality of life measures in the breastfeeding woman and basic infant health. If&#xD;
      the tea proves safe and effective, then it can provide a proven all-natural and organic&#xD;
      supplement for increasing lactation in women. This in turn will increase quality of life for&#xD;
      both the infant and the mother.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In order to establish the quality of life of combination herbal galactagogue tea in lactating&#xD;
      women, a randomized controlled trial of combination herbal galactagogue tea vs. placebo is&#xD;
      being undertaken in 120 fully lactating women beginning at 2-12 weeks postpartum for four&#xD;
      weeks. Women will be randomized to one of two teas: combination herbal galactagogue tea vs.&#xD;
      an herbal placebo tea. The study duration will be 4 weeks total beginning in the second to&#xD;
      twelfth week postpartum, with follow up phone calls at postpartum months 3, 6, 9 and 12, to&#xD;
      ascertain if the mother is continuing to breastfeed. During the 4-week study, participants&#xD;
      and their infants will have three scheduled outpatient visits to the Medical University of&#xD;
      South Carolina or an affiliated study center: one visit at 2-12 weeks postpartum, a second&#xD;
      visit at 4-14 weeks postpartum, and a final visit at 6-16 weeks postpartum. The first visit,&#xD;
      will include watching a video on how to correctly steep the tea and then brewing tea in the&#xD;
      presence of the study coordinator, in addition to the procedures listed below. This initial&#xD;
      visit will last approximately 90 minutes. Each subsequent visit will take less than 60&#xD;
      minutes for a maternal blood drawing, pumping a breast milk sample, answering questionnaires,&#xD;
      and both weighing and measuring the infant. Study participants will be given a study journal&#xD;
      to be completed with the number of cups of tea they drink every day and to document an&#xD;
      assessment of how they felt throughout the day both physically and emotionally. All&#xD;
      participants will receive telephone calls/texts, depending on the study participants&#xD;
      preferred method of communication. This will be done by a Study Coordinator at the end of&#xD;
      weeks 1 and 3 of the study in order to ensure safety and to remind them to complete their&#xD;
      journals. This call will also be an opportunity to assess if the participant is in need of&#xD;
      additional dietetic or lactation support by the team professionals or if she is having any&#xD;
      difficulty brewing her tea. At the last study visit, participants will be asked to call and&#xD;
      report any adverse events for 3 months after the end of their time on the active study.&#xD;
&#xD;
      Post Active-Study Communication: After the active-study, the Study Coordinators will call&#xD;
      each study participant when their infants are 3, 6, 9 and 12 months old, if applicable in&#xD;
      order to record the number of months that she continues to fully or partially breastfeed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 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>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life</measure>
    <time_frame>4 weeks</time_frame>
    <description>To determine quality of life, the following measurement tools will be compared across the 3 study visits:&#xD;
• The Satisfaction with Life Scale (Diener, Emmons et al. 1985; Pavot, Diener et al. 1991; Pavot and Diener 1993; Shevlin, Brunsden et al. 1998)-an overall global life satisfaction questionnaire.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life</measure>
    <time_frame>4 weeks</time_frame>
    <description>To determine quality of life, the following measurement tools will be compared across the 3 study visits:&#xD;
• World Health Organization's World Health Organization Quality of Life - Brief Survey [WHOQOL-BREF] (WHO 1997; Skevington, Lotfy et al. 2004)-Current perception of position in life in context of personal culture and value systems.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life</measure>
    <time_frame>4 weeks</time_frame>
    <description>To determine quality of life, the following measurement tools will be compared across the 3 study visits:&#xD;
• Edinburgh Postpartum Depression Inventory:(Murray and Carothers 1990)-a postpartum depression screen</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life</measure>
    <time_frame>4 weeks</time_frame>
    <description>To determine quality of life, the following measurement tools will be compared across the 3 study visits:&#xD;
• State-Trait Anxiety Inventory (STAI-Y) (Spielberger, Gorsuch et al. 1970; Ramanaiah, Franzen et al. 1983; Spielberger and Vagg 1984) -differentiates between temporary or emotional state anxiety versus long standing personality trait anxiety in adults.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oxytocin in maternal blood</measure>
    <time_frame>4 weeks</time_frame>
    <description>Blood will be collected at each of the 3 study visits. We will measure changes in maternal blood concentrations of oxytocin, across study groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prolactin in maternal blood</measure>
    <time_frame>4 weeks</time_frame>
    <description>Blood will be collected at each of the 3 study visits. We will measure changes in maternal blood concentrations of prolactin, across study groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composition of breast milk</measure>
    <time_frame>4 weeks</time_frame>
    <description>Measuring the quantities and quality of breast milk at the 3 study visits between groups. Checking the composition for milk caloric density and fatty acid content between the placebo and the combination galactagogue tea.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Lactation</condition>
  <arm_group>
    <arm_group_label>study herbal tea</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Supplementation of 3-5, 8 oz cups of study tea daily for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>herbal placebo tea</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Supplementation of 3-5, 8oz cups of tea daily for 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>study herbal tea</intervention_name>
    <description>3-5 cups, 8oz tea daily for 4 weeks</description>
    <arm_group_label>study herbal tea</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>herbal placebo tea</intervention_name>
    <description>3-5 cups, 8oz each daily for 4 weeks</description>
    <arm_group_label>herbal placebo tea</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women between the ages of 18 and 45 years&#xD;
&#xD;
          -  Good general health&#xD;
&#xD;
          -  Lactating&#xD;
&#xD;
          -  Singleton birth&#xD;
&#xD;
          -  Two to twelve weeks postpartum&#xD;
&#xD;
          -  Have a full term (&gt;37 weeks gestation) healthy infant&#xD;
&#xD;
          -  Is successfully fully breastfeeding at the time they enter the study&#xD;
&#xD;
          -  Intend to fully breastfeed their infants for the following 4 weeks at the time of&#xD;
             enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic illnesses (e.g. diabetes, hypertension, bronchial asthma, Gastroesophageal&#xD;
             Reflux Disease (GERD), atopic dermatitis, celiac disease or gluten sensitivity,&#xD;
             Crohn's Disease, ulcerative colitis, eating disorders, breast cancer, blood disorder,&#xD;
             psychiatric)&#xD;
&#xD;
          -  Pre-pregnant BMI (&gt;50)&#xD;
&#xD;
          -  History of alcohol, drug abuse or cigarette smoking&#xD;
&#xD;
          -  Currently using the following pharmaceuticals: diuretics, pseudoephedrine,&#xD;
             anticholinergics, and an estrogen-containing birth control pill or using an&#xD;
             estrogen-containing device&#xD;
&#xD;
          -  Currently consuming other drugs/herbals used to induce milk production including&#xD;
             metoclopramide, domperidone, or other drugs/herbals (i.e. fenugreek capsules, goat's&#xD;
             rue products, or &quot;More Milk&quot; capsules or tinctures)&#xD;
&#xD;
          -  Sensitivity or known allergies to peanuts, soybeans, or chick peas&#xD;
&#xD;
          -  Sensitivity or known allergies to plants in the Apiaceae/carrot plant family (e.g.&#xD;
             anise, celery, coriander, fennel) or the compound anethole&#xD;
&#xD;
          -  Sensitivity or known allergies to plants in the Asteraceae/daisy family (e.g. blessed&#xD;
             thistle, echinacea, or calendula)&#xD;
&#xD;
          -  Taking a selective serotonin reuptake inhibitor (SSRI)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bernadette Marriott, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of South Carolina</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carol Wagner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of South Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.facebook.com/SteepedwithLoveStudy</url>
    <description>Steeped with Love Study</description>
  </link>
  <reference>
    <citation>Academy Of Breastfeeding Medicine Protocol Committee. ABM Clinical Protocol #9: Use of galactogogues in initiating or augmenting the rate of maternal milk secretion (First Revision January 2011). Breastfeed Med. 2011 Feb;6(1):41-9. doi: 10.1089/bfm.2011.9998.</citation>
    <PMID>21332371</PMID>
  </reference>
  <reference>
    <citation>Turkyilmaz C, Onal E, Hirfanoglu IM, Turan O, Koc E, Ergenekon E, Atalay Y. The effect of galactagogue herbal tea on breast milk production and short-term catch-up of birth weight in the first week of life. J Altern Complement Med. 2011 Feb;17(2):139-42. doi: 10.1089/acm.2010.0090. Epub 2011 Jan 24.</citation>
    <PMID>21261516</PMID>
  </reference>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>July 15, 2013</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>July 2, 2018</last_update_submitted>
  <last_update_submitted_qc>July 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>galactogogue</keyword>
  <keyword>lactation</keyword>
  <keyword>milk production</keyword>
  <keyword>breastfeeding</keyword>
  <!-- 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/NCT02190448
org study id: SLS2013
nct id: NCT02190448
lead sponsor: 
collaborator: 
has dmc: Yes
The overall aims of this project are to 1) determine the quality of life effects of a
      combination herbal galactagogue tea in lactating women, and 2) measure changes in maternal
      blood concentration of oxytocin, prolactin, and milk production. The defined outcome measures
      will include quality of life measures in the breastfeeding woman and basic infant health. If
      the tea proves safe and effective, then it can provide a proven all-natural and organic
      supplement for increasing lactation in women. This in turn will increase quality of life for
      both the infant and the mother.
In order to establish the quality of life of combination herbal galactagogue tea in lactating
      women, a randomized controlled trial of combination herbal galactagogue tea vs. placebo is
      being undertaken in 120 fully lactating women beginning at 2-12 weeks postpartum for four
      weeks. Women will be randomized to one of two teas: combination herbal galactagogue tea vs.
      an herbal placebo tea. The study duration will be 4 weeks total beginning in the second to
      twelfth week postpartum, with follow up phone calls at postpartum months 3, 6, 9 and 12, to
      ascertain if the mother is continuing to breastfeed. During the 4-week study, participants
      and their infants will have three scheduled outpatient visits to the Medical University of
      South Carolina or an affiliated study center: one visit at 2-12 weeks postpartum, a second
      visit at 4-14 weeks postpartum, and a final visit at 6-16 weeks postpartum. The first visit,
      will include watching a video on how to correctly steep the tea and then brewing tea in the
      presence of the study coordinator, in addition to the procedures listed below. This initial
      visit will last approximately 90 minutes. Each subsequent visit will take less than 60
      minutes for a maternal blood drawing, pumping a breast milk sample, answering questionnaires,
      and both weighing and measuring the infant. Study participants will be given a study journal
      to be completed with the number of cups of tea they drink every day and to document an
      assessment of how they felt throughout the day both physically and emotionally. All
      participants will receive telephone calls/texts, depending on the study participants
      preferred method of communication. This will be done by a Study Coordinator at the end of
      weeks 1 and 3 of the study in order to ensure safety and to remind them to complete their
      journals. This call will also be an opportunity to assess if the participant is in need of
      additional dietetic or lactation support by the team professionals or if she is having any
      difficulty brewing her tea. At the last study visit, participants will be asked to call and
      report any adverse events for 3 months after the end of their time on the active study.

      Post Active-Study Communication: After the active-study, the Study Coordinators will call
      each study participant when their infants are 3, 6, 9 and 12 months old, if applicable in
      order to record the number of months that she continues to fully or partially breastfeed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
measure: Quality of life
time frame: 4 weeks
description: To determine quality of life, the following measurement tools will be compared across the 3 study visits:
• The Satisfaction with Life Scale (Diener, Emmons et al. 1985; Pavot, Diener et al. 1991; Pavot and Diener 1993; Shevlin, Brunsden et al. 1998)-an overall global life satisfaction questionnaire.
measure: Quality of life
time frame: 4 weeks
description: To determine quality of life, the following measurement tools will be compared across the 3 study visits:
• World Health Organization's World Health Organization Quality of Life - Brief Survey [WHOQOL-BREF] (WHO 1997; Skevington, Lotfy et al. 2004)-Current perception of position in life in context of personal culture and value systems.
measure: Quality of life
time frame: 4 weeks
description: To determine quality of life, the following measurement tools will be compared across the 3 study visits:
• Edinburgh Postpartum Depression Inventory:(Murray and Carothers 1990)-a postpartum depression screen
measure: Quality of life
time frame: 4 weeks
description: To determine quality of life, the following measurement tools will be compared across the 3 study visits:
• State-Trait Anxiety Inventory (STAI-Y) (Spielberger, Gorsuch et al. 1970; Ramanaiah, Franzen et al. 1983; Spielberger and Vagg 1984) -differentiates between temporary or emotional state anxiety versus long standing personality trait anxiety in adults.
measure: Oxytocin in maternal blood
time frame: 4 weeks
description: Blood will be collected at each of the 3 study visits. We will measure changes in maternal blood concentrations of oxytocin, across study groups.
measure: Prolactin in maternal blood
time frame: 4 weeks
description: Blood will be collected at each of the 3 study visits. We will measure changes in maternal blood concentrations of prolactin, across study groups.
measure: Composition of breast milk
time frame: 4 weeks
description: Measuring the quantities and quality of breast milk at the 3 study visits between groups. Checking the composition for milk caloric density and fatty acid content between the placebo and the combination galactagogue tea.
arm group label: study herbal tea
arm group type: Experimental
description: Supplementation of 3-5, 8 oz cups of study tea daily for 4 weeks.
arm group label: herbal placebo tea
arm group type: Placebo Comparator
description: Supplementation of 3-5, 8oz cups of tea daily for 4 weeks.
intervention type: Dietary Supplement
intervention name: study herbal tea
description: 3-5 cups, 8oz tea daily for 4 weeks
arm group label: study herbal tea
intervention type: Dietary Supplement
intervention name: herbal placebo tea
description: 3-5 cups, 8oz each daily for 4 weeks
arm group label: herbal placebo tea
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bernadette Marriott, PhD
role: Principal Investigator
affiliation: Medical University of South Carolina
last name: Carol Wagner, MD
role: Principal Investigator
affiliation: Medical University of South Carolina
facility: 
country: United States
url: https://www.facebook.com/SteepedwithLoveStudy
description: Steeped with Love Study
citation: Academy Of Breastfeeding Medicine Protocol Committee. ABM Clinical Protocol #9: Use of galactogogues in initiating or augmenting the rate of maternal milk secretion (First Revision January 2011). Breastfeed Med. 2011 Feb;6(1):41-9. doi: 10.1089/bfm.2011.9998.
PMID: 21332371
citation: Turkyilmaz C, Onal E, Hirfanoglu IM, Turan O, Koc E, Ergenekon E, Atalay Y. The effect of galactagogue herbal tea on breast milk production and short-term catch-up of birth weight in the first week of life. J Altern Complement Med. 2011 Feb;17(2):139-42. doi: 10.1089/acm.2010.0090. Epub 2011 Jan 24.
PMID: 21261516
responsible party type: Sponsor