<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/NCT03806062</url>
  </required_header>
  <id_info>
    <org_study_id>48</org_study_id>
    <nct_id>NCT03806062</nct_id>
  </id_info>
  <brief_title>EFFECT OF LOW LEVEL LASER THERAPY VERSUS ELECTROACUPUNCTURE ON POSTNATAL SCANTY MILK SECRETION</brief_title>
  <official_title>EFFECT OF LOW LEVEL LASER THERAPY VERSUS ELECTROACUPUNCTURE ON POSTNATAL SCANTY MILK SECRETION</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</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>
      A randomized controlled study conducted on 60 healthy primiparous mothers with insufficient&#xD;
      lactation. The participants were divided randomly into three equal groups, Group (A) control,&#xD;
      Group (B) received low power He-Ne laser beam on both breasts and Group (C) received faradic&#xD;
      current stimulation at Spleen 6, Liver 3 and Small Intestine 1 acupuncture points on both&#xD;
      sides, all participants received 10 mg domperidone 3 times a day and advice about lactation,&#xD;
      nutrition and fluid intake. Evaluation was done before and after the treatment program&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Women in Group (A) acted as a control group and only received medical treatment in the form&#xD;
      of 10 mg domperidone 3 times a day after meals) and advice about lactation, nutrition and&#xD;
      fluid intake all through the treatment period (4 weeks) Each woman in group (B) lied in&#xD;
      supine lying position on the treatment plinth wearing the protective eyewear as precautionary&#xD;
      measures for her safety and exposing her breast out of her clothes then the breast was&#xD;
      cleaned by alcohol. The laser apparatus was directed perpendicularly over the treated breast&#xD;
      at a distance 50 cm from it, all metal objects must be removed from the range of action of&#xD;
      laser (i.e. necklaces). The laser scan beam was adjusted to the size of the treated breast&#xD;
      for 10 minutes with wave length 632.8 nm and power output 25 mw after the end of treatment&#xD;
      session the machine switched off automatically then, it was adjusted again to start&#xD;
      irradiation by the same procedures for the other breast. The mother had one session every&#xD;
      other day, three sessions weekly for four weeks. (Total 12 sessions). He-Ne laser (Bravo&#xD;
      TrezaSerie) device was used. The equipment was designed in compliance with international&#xD;
      technical standards UNI EN ISO 9002 and En 46002 and complies with the safety requirements.&#xD;
&#xD;
      Group (B) had received 12 sessions of irradiation by low power He-Ne laser beam on both sides&#xD;
      of the breasts 10 minutes on each side. One session every other day, three sessions weekly&#xD;
      for four weeks beside the medical treatment (10 mg domperidone 3 times a day after meals) and&#xD;
      advice about lactation, nutrition and fluid intake all through the treatment period Group (C)&#xD;
      women were treated by faradic stimulation (Body shaping System, model B-333, made in China) ,&#xD;
      at the following acupuncture points on both sides: Spleen 6 (Sanyinjiao), Liver 3 (Taichong)&#xD;
      and Small Intestine 1 (Shaoze) using surface electrodes in addition to medical treatment (10&#xD;
      mg domperidone 3 times a day after meals) and advice about lactation, nutrition and fluid&#xD;
      intake allthrough the treatment period&#xD;
&#xD;
      SP-6 Acupuncture Point lies on the inner leg aspect about 3 cm higher than the medial&#xD;
      malleolus, along the posterior tibial border. Fig. (2)&#xD;
&#xD;
      LIV-3 Acupuncture Point is the one that lies in the depressed area between the 1st 2&#xD;
      metatarsal bones proximal to the metatarsophalangeal joints on the dorsal foot aspect Fig.&#xD;
      (2)&#xD;
&#xD;
      SI.1 Acupuncture point is located on the little finger, ulnar to the distal phalanx, at the&#xD;
      intersection of the vertical line of ulnar border of the nail and the horizontal line of the&#xD;
      base of the little fingernail. Fig. (2)&#xD;
&#xD;
      Each woman in group (C) was asked to be in a long sitting or half lying position, When the&#xD;
      points were located, the electrodes were fastened securely with an adhesive tape or an&#xD;
      elastic band to ensure good contact between the skin and the electrode over the acupuncture&#xD;
      points. The intensity control of the stimulator was slowly increased until the patient could&#xD;
      just feel the stimulation. The session lasted for 30 minutes. One session every other day, 3&#xD;
      sessions weekly for 4 weeks. (Total 12 sessions).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2018</start_date>
  <completion_date type="Actual">January 2, 2019</completion_date>
  <primary_completion_date type="Actual">December 4, 2018</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>serum prolactin</measure>
    <time_frame>12 weeks after treatment</time_frame>
    <description>the mean difference in the value of serum prolactin between the three studied groups measured at post-treatment</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Insufficient Lactation</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10 mg domperidone 3 times a day after meals) and advice about lactation, nutrition and fluid intake all through the treatment period (4 weeks)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laser group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The laser scan beam was adjusted to the size of the treated breast for 10 minutes with wave length 632.8 nm and power output 25 mw after the end of treatment session on both breasts.&#xD;
The mother had one session every other day, three sessions weekly for four weeks. (Total 12 sessions)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Electro acupuncture group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>faradic stimulation (Body shaping System, model B-333, made in China) , at the following acupuncture points on both sides: Spleen 6 (Sanyinjiao), Liver 3 (Taichong) and Small Intestine 1 (Shaoze) using surface electrodes</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>domperidone</intervention_name>
    <description>10 mg domperidone 3 times a day after meals</description>
    <arm_group_label>Electro acupuncture group</arm_group_label>
    <arm_group_label>Laser group</arm_group_label>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>He-Ne laser (Bravo TrezaSerie) device</intervention_name>
    <description>The laser scan beam was adjusted to the size of the treated breast for 10 minutes with wave length 632.8 nm and power output 25 mw after the end of treatment session</description>
    <arm_group_label>Laser group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>faradic current</intervention_name>
    <description>faradic stimulation (Body shaping System, model B-333, made in China) , at the following acupuncture points on both sides: Spleen 6 (Sanyinjiao), Liver 3 (Taichong) and Small Intestine 1 (Shaoze)</description>
    <arm_group_label>Electro acupuncture group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Their age ranged between 20 and 35 years old&#xD;
&#xD;
          -  25 to 30 kg/m² body mass index (BMI).&#xD;
&#xD;
          -  They attended the breast feeding clinic complaining from insufficiency of lactation&#xD;
             within the 1st month after normal vaginal delivery and they were using mixed feeding&#xD;
             (Both breast and bottle feeding at least 3 bottles per day and not more than 6&#xD;
             bottles).&#xD;
&#xD;
          -  They had approximately the same nutrition as well as, education level&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  lactating mothers who suffered from post-partum hemorrhage&#xD;
&#xD;
          -  cardio respiratory disease&#xD;
&#xD;
          -  diabetes mellitus&#xD;
&#xD;
          -  breast cancer&#xD;
&#xD;
          -  previous surgeries in the chest, breast or the surrounding area&#xD;
&#xD;
          -  anemia&#xD;
&#xD;
          -  those who had any causes that hindering their normal breast feeding as (retraced,&#xD;
             cracked, inflamed or inverted nipples)&#xD;
&#xD;
          -  Women receiving contraceptive pills,&#xD;
&#xD;
          -  conditions related to the infant that affect the lactation process were excluded such&#xD;
             as congenital conditions of infant mouth: tongue tie, cleft of the soft palate and&#xD;
             congenital heart disease of the infant&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Maged</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kasr Alainy medical school</name>
      <address>
        <city>Cairo</city>
        <zip>12151</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 13, 2019</study_first_submitted>
  <study_first_submitted_qc>January 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 13, 2019</last_update_submitted>
  <last_update_submitted_qc>January 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Maged</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Domperidone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03806062
org study id: 48
nct id: NCT03806062
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A randomized controlled study conducted on 60 healthy primiparous mothers with insufficient
      lactation. The participants were divided randomly into three equal groups, Group (A) control,
      Group (B) received low power He-Ne laser beam on both breasts and Group (C) received faradic
      current stimulation at Spleen 6, Liver 3 and Small Intestine 1 acupuncture points on both
      sides, all participants received 10 mg domperidone 3 times a day and advice about lactation,
      nutrition and fluid intake. Evaluation was done before and after the treatment program
Women in Group (A) acted as a control group and only received medical treatment in the form
      of 10 mg domperidone 3 times a day after meals) and advice about lactation, nutrition and
      fluid intake all through the treatment period (4 weeks) Each woman in group (B) lied in
      supine lying position on the treatment plinth wearing the protective eyewear as precautionary
      measures for her safety and exposing her breast out of her clothes then the breast was
      cleaned by alcohol. The laser apparatus was directed perpendicularly over the treated breast
      at a distance 50 cm from it, all metal objects must be removed from the range of action of
      laser (i.e. necklaces). The laser scan beam was adjusted to the size of the treated breast
      for 10 minutes with wave length 632.8 nm and power output 25 mw after the end of treatment
      session the machine switched off automatically then, it was adjusted again to start
      irradiation by the same procedures for the other breast. The mother had one session every
      other day, three sessions weekly for four weeks. (Total 12 sessions). He-Ne laser (Bravo
      TrezaSerie) device was used. The equipment was designed in compliance with international
      technical standards UNI EN ISO 9002 and En 46002 and complies with the safety requirements.

      Group (B) had received 12 sessions of irradiation by low power He-Ne laser beam on both sides
      of the breasts 10 minutes on each side. One session every other day, three sessions weekly
      for four weeks beside the medical treatment (10 mg domperidone 3 times a day after meals) and
      advice about lactation, nutrition and fluid intake all through the treatment period Group (C)
      women were treated by faradic stimulation (Body shaping System, model B-333, made in China) ,
      at the following acupuncture points on both sides: Spleen 6 (Sanyinjiao), Liver 3 (Taichong)
      and Small Intestine 1 (Shaoze) using surface electrodes in addition to medical treatment (10
      mg domperidone 3 times a day after meals) and advice about lactation, nutrition and fluid
      intake allthrough the treatment period

      SP-6 Acupuncture Point lies on the inner leg aspect about 3 cm higher than the medial
      malleolus, along the posterior tibial border. Fig. (2)

      LIV-3 Acupuncture Point is the one that lies in the depressed area between the 1st 2
      metatarsal bones proximal to the metatarsophalangeal joints on the dorsal foot aspect Fig.
      (2)

      SI.1 Acupuncture point is located on the little finger, ulnar to the distal phalanx, at the
      intersection of the vertical line of ulnar border of the nail and the horizontal line of the
      base of the little fingernail. Fig. (2)

      Each woman in group (C) was asked to be in a long sitting or half lying position, When the
      points were located, the electrodes were fastened securely with an adhesive tape or an
      elastic band to ensure good contact between the skin and the electrode over the acupuncture
      points. The intensity control of the stimulator was slowly increased until the patient could
      just feel the stimulation. The session lasted for 30 minutes. One session every other day, 3
      sessions weekly for 4 weeks. (Total 12 sessions).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: serum prolactin
time frame: 12 weeks after treatment
description: the mean difference in the value of serum prolactin between the three studied groups measured at post-treatment
arm group label: control group
arm group type: Active Comparator
description: 10 mg domperidone 3 times a day after meals) and advice about lactation, nutrition and fluid intake all through the treatment period (4 weeks)
arm group label: Laser group
arm group type: Active Comparator
description: The laser scan beam was adjusted to the size of the treated breast for 10 minutes with wave length 632.8 nm and power output 25 mw after the end of treatment session on both breasts.
The mother had one session every other day, three sessions weekly for four weeks. (Total 12 sessions)
arm group label: Electro acupuncture group
arm group type: Active Comparator
description: faradic stimulation (Body shaping System, model B-333, made in China) , at the following acupuncture points on both sides: Spleen 6 (Sanyinjiao), Liver 3 (Taichong) and Small Intestine 1 (Shaoze) using surface electrodes
intervention type: Drug
intervention name: domperidone
description: 10 mg domperidone 3 times a day after meals
arm group label: Electro acupuncture group
arm group label: Laser group
arm group label: control group
intervention type: Device
intervention name: He-Ne laser (Bravo TrezaSerie) device
description: The laser scan beam was adjusted to the size of the treated breast for 10 minutes with wave length 632.8 nm and power output 25 mw after the end of treatment session
arm group label: Laser group
intervention type: Device
intervention name: faradic current
description: faradic stimulation (Body shaping System, model B-333, made in China) , at the following acupuncture points on both sides: Spleen 6 (Sanyinjiao), Liver 3 (Taichong) and Small Intestine 1 (Shaoze)
arm group label: Electro acupuncture group
criteria: 
gender: Female
gender based: Yes
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: No
last name: Ahmed Maged
role: Principal Investigator
affiliation: Professor
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Maged
investigator title: Principal investigator
mesh term: Domperidone
sharing ipd: Undecided