<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/NCT04416880</url>
  </required_header>
  <id_info>
    <org_study_id>Medical Acupuncture 2019</org_study_id>
    <nct_id>NCT04416880</nct_id>
  </id_info>
  <brief_title>Effectiveness of Press Tack Needle Acupuncture in Treating Lactation Insufficiency</brief_title>
  <official_title>Effectiveness of Press Tack Needle Acupuncture in Treating Lactation Insufficiency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indonesia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indonesia University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was meant to see the effectiveness of press tack needle acupuncture in improving&#xD;
      lactation insufficiency. The acupuncture points used in this study were CV17 Danzhong and SI1&#xD;
      Shaoze. Press Tack Needles were placed in these acupuncture points for 7 days in hope that it&#xD;
      will give continuous acupuncture stimulation that might help in improving lactation&#xD;
      insufficiency with minimal side effect, less time consuming, and more efficient for the&#xD;
      patient.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 13, 2019</start_date>
  <completion_date type="Actual">February 18, 2020</completion_date>
  <primary_completion_date type="Actual">February 18, 2020</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Breastmilk Volume</measure>
    <time_frame>Day 7 of acupuncture or sham treatment</time_frame>
    <description>Pre- and Post Treatment Breastmilk Volume were measured using electric breast pump</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Breastmilk Volume</measure>
    <time_frame>Day 10 of acupuncture or sham treatment (Day 3 after press tack needles were removed)</time_frame>
    <description>Pre- and Post Treatment Breastmilk Volume were measured using electric breast pump</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Lactation; Insufficient, Partial</condition>
  <condition>Hypogalactia, Without Mention of Attachment Difficulty</condition>
  <arm_group>
    <arm_group_label>Press Tack Needle Acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group were given seirin pyonex press tack needle treatment in the acupuncture points CV17 Danzhong and SI1 Shaoze bilateral for 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Control Press Tack Needle Acupuncture</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients in this group were given sham treatment in the acupuncture points CV17 Danzhong and SI1 Shaoze bilateral for 7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Press Tack Needle Acupuncture</intervention_name>
    <description>Seirin Pyonex Press Tack Needle 0.20 x 0.60 mm for SI1 Shaoze acupuncture point Seirin Pyonex Press Tack Needle 0.20 x 0.90 mm for CV17 Danzhong acupuncture point</description>
    <arm_group_label>Press Tack Needle Acupuncture</arm_group_label>
    <arm_group_label>Sham Control Press Tack Needle Acupuncture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Breastfeeding mother who suffers from lactation insufficiency&#xD;
&#xD;
          -  Breastfeeding mother from 2 weeks to 5 months post-partum&#xD;
&#xD;
          -  Breastfeeding mother with healthy baby&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject consumes drugs that are known to decrease breastmilk production&#xD;
&#xD;
          -  Subject with infection or inflammation in the intended acupuncture points&#xD;
&#xD;
          -  Subject with bleeding disorder&#xD;
&#xD;
          -  Subject consumes anticoagulant&#xD;
&#xD;
          -  Subject with known diabetic history&#xD;
&#xD;
          -  Subject with body temperature &gt; 38 degree celcius&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Breastfeeding mothers</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Diana Oei, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of Medicine University of Indonesia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Puskesmas Kecamatan Menteng</name>
      <address>
        <city>Jakarta Pusat</city>
        <state>DKI Jakarta</state>
        <zip>10310</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Poliklinik Akupunktur Medik RSCM</name>
      <address>
        <city>Jakarta Pusat</city>
        <state>DKI Jakarta</state>
        <zip>10430</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Puskesmas Kelurahan Pegangsaan</name>
      <address>
        <city>Jakarta Pusat</city>
        <state>DKI Jakarta</state>
        <zip>13150</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Indonesia</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indonesia University</investigator_affiliation>
    <investigator_full_name>dr. Diana Oei</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>acupuncture</keyword>
  <keyword>exclusive breastfeeding</keyword>
  <keyword>breastmilk</keyword>
  <keyword>press tack needle</keyword>
  <keyword>lactation insufficiency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lactation Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </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/NCT04416880
org study id: Medical Acupuncture 2019
nct id: NCT04416880
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study was meant to see the effectiveness of press tack needle acupuncture in improving
      lactation insufficiency. The acupuncture points used in this study were CV17 Danzhong and SI1
      Shaoze. Press Tack Needles were placed in these acupuncture points for 7 days in hope that it
      will give continuous acupuncture stimulation that might help in improving lactation
      insufficiency with minimal side effect, less time consuming, and more efficient for the
      patient.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Breastmilk Volume
time frame: Day 7 of acupuncture or sham treatment
description: Pre- and Post Treatment Breastmilk Volume were measured using electric breast pump
measure: Breastmilk Volume
time frame: Day 10 of acupuncture or sham treatment (Day 3 after press tack needles were removed)
description: Pre- and Post Treatment Breastmilk Volume were measured using electric breast pump
arm group label: Press Tack Needle Acupuncture
arm group type: Experimental
description: Patients in this group were given seirin pyonex press tack needle treatment in the acupuncture points CV17 Danzhong and SI1 Shaoze bilateral for 7 days.
arm group label: Sham Control Press Tack Needle Acupuncture
arm group type: Sham Comparator
description: Patients in this group were given sham treatment in the acupuncture points CV17 Danzhong and SI1 Shaoze bilateral for 7 days.
intervention type: Device
intervention name: Press Tack Needle Acupuncture
description: Seirin Pyonex Press Tack Needle 0.20 x 0.60 mm for SI1 Shaoze acupuncture point Seirin Pyonex Press Tack Needle 0.20 x 0.90 mm for CV17 Danzhong acupuncture point
arm group label: Press Tack Needle Acupuncture
arm group label: Sham Control Press Tack Needle Acupuncture
criteria: 
gender: Female
gender based: Yes
gender description: Breastfeeding mothers
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Diana Oei, MD
role: Principal Investigator
affiliation: Faculty of Medicine University of Indonesia
facility: 
facility: 
facility: 
country: Indonesia
responsible party type: Principal Investigator
investigator affiliation: Indonesia University
investigator full name: dr. Diana Oei
investigator title: Principal Investigator
mesh term: Lactation Disorders
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)