<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/NCT03230760</url>
  </required_header>
  <id_info>
    <org_study_id>CF17141A</org_study_id>
    <nct_id>NCT03230760</nct_id>
  </id_info>
  <brief_title>Acupuncture for Breast Engorgement During Lactation</brief_title>
  <official_title>Acupuncture for Breast Engorgement During Lactation: a Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taichung Veterans General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taichung Veterans General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Breast engorgement which may manifest swell, throb, and cause mild to extreme pain is the&#xD;
      common difficulty for breast feeding woman. It occurs in the mammary glands due to expansion&#xD;
      and pressure exerted by the synthesis and storage of breast milk and it usually happens when&#xD;
      the breasts switch from colostrums to mature milk. However, engorgement can also happen if&#xD;
      lactating women miss several nursing and not enough milk is expressed from the breasts. It&#xD;
      can be exacerbated by insufficient breastfeeding and/or blocked milk ducts. Engorgement may&#xD;
      lead to mastitis and untreated engorgement puts pressure on the milk ducts, often causing a&#xD;
      plugged duct.&#xD;
&#xD;
      According the meridian theory, the investigators propose the acupuncture treatment for&#xD;
      patients of breast engorgement.&#xD;
&#xD;
      The investigators will include 60 patients and measure the acupuncture effect. The inclusion&#xD;
      criteria are women with breast engorgement and 20 years old or older. Exclusion standards are&#xD;
      patients with: 1. diabetes mellitus 2. Psychological disease or mental illness 3. Fever &gt; 38&#xD;
      degrees Celsius 4. Mastitis 5.analgetics or anti - inflammatory agents used 6. ultrasound&#xD;
      therapy applied&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 18, 2017</start_date>
  <completion_date type="Anticipated">June 26, 2018</completion_date>
  <primary_completion_date type="Anticipated">June 26, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>breast engorgement</measure>
    <time_frame>3 days</time_frame>
    <description>Six-point Engorgement Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>mastitis</measure>
    <time_frame>3 days</time_frame>
    <description>The incidence of mastitis</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Breast Engorgement</condition>
  <arm_group>
    <arm_group_label>treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>acupuncture</intervention_name>
    <description>Device: acupuncture Acupuncture is the treatment which balances qi and blood by inserting needles into the acupoints of the meridians in human body.</description>
    <arm_group_label>treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women with breast engorgement and 20 years old or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with:&#xD;
&#xD;
               1. diabetes mellitus&#xD;
&#xD;
               2. psychological disease or mental illness&#xD;
&#xD;
               3. Fever &gt; 38 degrees Celsius&#xD;
&#xD;
               4. Mastitis&#xD;
&#xD;
               5. analgesics or anti - inflammatory agents used&#xD;
&#xD;
               6. ultrasound therapy applied&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>PeiJung Chiang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Traditional Chinese Medicine department</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>ShuHuey Chou</last_name>
    <phone>886963826707</phone>
    <email>lummdo@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>407</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>PeiJung Chiang</last_name>
      <phone>886963826707</phone>
      <email>aerin.chiang@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>TCM</name>
      <address>
        <city>Taichung</city>
        <zip>407</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PeiJung Chiang</last_name>
      <phone>886963826707</phone>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <results_reference>
    <citation>Mangesi L, Zakarija-Grkovic I. Treatments for breast engorgement during lactation. Cochrane Database Syst Rev. 2016 Jun 28;2016(6):CD006946. doi: 10.1002/14651858.CD006946.pub3.</citation>
    <PMID>27351423</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>August 1, 2017</last_update_submitted>
  <last_update_submitted_qc>August 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taichung Veterans General Hospital</investigator_affiliation>
    <investigator_full_name>PeiJung Chiang</investigator_full_name>
    <investigator_title>physician</investigator_title>
  </responsible_party>
  <keyword>acupuncture</keyword>
  <keyword>breast engorgement</keyword>
  <keyword>lactation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03230760
org study id: CF17141A
nct id: NCT03230760
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Breast engorgement which may manifest swell, throb, and cause mild to extreme pain is the
      common difficulty for breast feeding woman. It occurs in the mammary glands due to expansion
      and pressure exerted by the synthesis and storage of breast milk and it usually happens when
      the breasts switch from colostrums to mature milk. However, engorgement can also happen if
      lactating women miss several nursing and not enough milk is expressed from the breasts. It
      can be exacerbated by insufficient breastfeeding and/or blocked milk ducts. Engorgement may
      lead to mastitis and untreated engorgement puts pressure on the milk ducts, often causing a
      plugged duct.

      According the meridian theory, the investigators propose the acupuncture treatment for
      patients of breast engorgement.

      The investigators will include 60 patients and measure the acupuncture effect. The inclusion
      criteria are women with breast engorgement and 20 years old or older. Exclusion standards are
      patients with: 1. diabetes mellitus 2. Psychological disease or mental illness 3. Fever > 38
      degrees Celsius 4. Mastitis 5.analgetics or anti - inflammatory agents used 6. ultrasound
      therapy applied
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: breast engorgement
time frame: 3 days
description: Six-point Engorgement Scale
measure: mastitis
time frame: 3 days
description: The incidence of mastitis
arm group label: treatment
arm group type: Experimental
intervention type: Device
intervention name: acupuncture
description: Device: acupuncture Acupuncture is the treatment which balances qi and blood by inserting needles into the acupoints of the meridians in human body.
arm group label: treatment
criteria: 
gender: Female
gender based: Yes
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: PeiJung Chiang
role: Principal Investigator
affiliation: Traditional Chinese Medicine department
last name: ShuHuey Chou
phone: 886963826707
email: lummdo@gmail.com
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Taiwan
citation: Mangesi L, Zakarija-Grkovic I. Treatments for breast engorgement during lactation. Cochrane Database Syst Rev. 2016 Jun 28;2016(6):CD006946. doi: 10.1002/14651858.CD006946.pub3.
PMID: 27351423
responsible party type: Principal Investigator
investigator affiliation: Taichung Veterans General Hospital
investigator full name: PeiJung Chiang
investigator title: physician
mesh term: Hyperemia
sharing ipd: No