<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/NCT03005821</url>
  </required_header>
  <id_info>
    <org_study_id>2013B032500014</org_study_id>
    <nct_id>NCT03005821</nct_id>
  </id_info>
  <brief_title>Chinese Pediatric Massage on Children With Acute Diarrhea: a Randomized Sham Massage Controlled Trial</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dongguan Kanghua Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Guangzhou University of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy of Chinese pediatric massage as an&#xD;
      add-on therapy while comparing with sham massage both on the basis of usual care for 0-6&#xD;
      years old children with acute diarrhea.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chinese pediatric massage has been practised as an option for the treatment of pediatric&#xD;
      diarrhea for hundreds of years (since Ming Dynasty). The history of Chinese pediatric massage&#xD;
      for health promotion is much longer, it can be traced back to more than one thousand years&#xD;
      ago (652 AD). Many of the acupoints adopted in Chinese pediatric massage are unique if it is&#xD;
      compared with those for adult massage. The manipulation is found to be easily accepted by&#xD;
      children, as the strength of massage is gentle and soft. No severe adverse reaction in&#xD;
      regards of Chinese pediatric massage was reported, the mild adverse reaction such as skin&#xD;
      abrasion can be completely avoided with correct operating instructions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">October 25, 2019</completion_date>
  <primary_completion_date type="Actual">October 25, 2019</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diarrhea days</measure>
    <time_frame>Within 14 days, the period of days from baseline to the first day that the diarrhea time reduces to equal to or less than 2 times per day.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The diarrhea times</measure>
    <time_frame>On the 3rd day.</time_frame>
    <description>The baseline and the 1st day of intervention are on the same day.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Global change rating</measure>
    <time_frame>On the 7th day and 14th day from baseline (the baseline and the 1st day of intervention are on the same day).</time_frame>
    <description>much better，slightly better，unchanged，slightly worse，much worse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Period of days when the stool character turns to normal</measure>
    <time_frame>Within 14 days, the period of days from baseline to the first day that the stool character turns to normal.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events</measure>
    <time_frame>Within 14 days</time_frame>
    <description>monitor adverse events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">84</enrollment>
  <condition>Diarrhea</condition>
  <arm_group>
    <arm_group_label>pediatric massage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive Montmorillonite Powder and racecadotril granules as usual care according to different age or weight. Intravenous infusion, Oral Rehydration Salts (ORS), Zn,and antibiotics will be used if the pediatrician in charge considers necessary. Patients will receive Chinese pediatric massage once per day and for three days continuously. A cloak which can cover the child's hands and upper body will be required to put on, all the manipulations will be done under the cloak. Six acupoints will be adopted,i.e. Neibagua, Dachang,Xiaochang, Banmen, Fu, Tuishang Qijiegu. Each visit, children who are under 2 years old will receive manipulations on Neibagua for 500 times, 300 times for the other 5 acupoints each; if they are from 2-3 years old, the manipulations on Neibagua will be 700 times and 500 times for the other 5 acupoints respectively; while the manipulations on Neibagua will be 1000 times, and 800 times for the other 5 acupoints if the children are from 4-6 years old.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham massage</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients will receive the same usual care as the experimental group. For the sham massage, the therapist will use one hand to hold the childrens' hand or just put one hand on childrens' body and the other hand will do the manipulations on the therapist's own hand instead childrens' hand or childrens' body. Patients will be required to put on the same kind of cloak as that for the the experimental group, all the manipulations will be done under the cloak. The manipulation times for each acupoints will be the same as those for experimental group in accordance with different age. The sham massage will be given once per day for 3 days continuously.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Chinese pediatric massage therapy + usual care</intervention_name>
    <arm_group_label>pediatric massage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham massage therapy + usual care</intervention_name>
    <arm_group_label>sham massage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject's symptoms meet the diagnosis criteria of acute diarrhea.&#xD;
&#xD;
          2. The occurrence of diarrhea is no more than 72 hours.&#xD;
&#xD;
          3. Stool frequency is equal or more than 5 times a day.&#xD;
&#xD;
          4. Subject has not been involved in any other clinical trials at the same period of time.&#xD;
&#xD;
          5. Subject's guardian may coordinate during the clinical trial.&#xD;
&#xD;
          6. Subject's guardian have signed the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A history of experiencing Chinese pediatric massage on hands&#xD;
&#xD;
          2. Subject has cholera or malaria&#xD;
&#xD;
          3. Subject with the following conditions on the manipulating part: phlebitis，open&#xD;
             wound，fracture，tissue damage&#xD;
&#xD;
          4. Subject has the follow complications: severe dehydration，metabolic acidosis，disorders&#xD;
             of consciousness, seizures or twitching, shock, azotemia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dongguan Kanghua Hospital</name>
      <address>
        <city>Dongguan</city>
        <state>Guangdong</state>
        <zip>523080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>December 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>October 25, 2019</last_update_submitted>
  <last_update_submitted_qc>October 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangzhou University of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Darong Wu</investigator_full_name>
    <investigator_title>MD, PhD, Director,Program for Outcome Assessment in TCM, Professor, Chief Physician</investigator_title>
  </responsible_party>
  <keyword>pediatric massage</keyword>
  <keyword>Tuina therapy</keyword>
  <keyword>acute diarrhea</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diarrhea</mesh_term>
  </condition_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/NCT03005821
org study id: 2013B032500014
nct id: NCT03005821
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate the efficacy of Chinese pediatric massage as an
      add-on therapy while comparing with sham massage both on the basis of usual care for 0-6
      years old children with acute diarrhea.
Chinese pediatric massage has been practised as an option for the treatment of pediatric
      diarrhea for hundreds of years (since Ming Dynasty). The history of Chinese pediatric massage
      for health promotion is much longer, it can be traced back to more than one thousand years
      ago (652 AD). Many of the acupoints adopted in Chinese pediatric massage are unique if it is
      compared with those for adult massage. The manipulation is found to be easily accepted by
      children, as the strength of massage is gentle and soft. No severe adverse reaction in
      regards of Chinese pediatric massage was reported, the mild adverse reaction such as skin
      abrasion can be completely avoided with correct operating instructions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Diarrhea days
time frame: Within 14 days, the period of days from baseline to the first day that the diarrhea time reduces to equal to or less than 2 times per day.
measure: The diarrhea times
time frame: On the 3rd day.
description: The baseline and the 1st day of intervention are on the same day.
measure: Global change rating
time frame: On the 7th day and 14th day from baseline (the baseline and the 1st day of intervention are on the same day).
description: much better，slightly better，unchanged，slightly worse，much worse
measure: Period of days when the stool character turns to normal
time frame: Within 14 days, the period of days from baseline to the first day that the stool character turns to normal.
measure: Incidence of Treatment-Emergent Adverse Events
time frame: Within 14 days
description: monitor adverse events
arm group label: pediatric massage
arm group type: Experimental
description: Patients will receive Montmorillonite Powder and racecadotril granules as usual care according to different age or weight. Intravenous infusion, Oral Rehydration Salts (ORS), Zn,and antibiotics will be used if the pediatrician in charge considers necessary. Patients will receive Chinese pediatric massage once per day and for three days continuously. A cloak which can cover the child's hands and upper body will be required to put on, all the manipulations will be done under the cloak. Six acupoints will be adopted,i.e. Neibagua, Dachang,Xiaochang, Banmen, Fu, Tuishang Qijiegu. Each visit, children who are under 2 years old will receive manipulations on Neibagua for 500 times, 300 times for the other 5 acupoints each; if they are from 2-3 years old, the manipulations on Neibagua will be 700 times and 500 times for the other 5 acupoints respectively; while the manipulations on Neibagua will be 1000 times, and 800 times for the other 5 acupoints if the children are from 4-6 years old.
arm group label: sham massage
arm group type: Sham Comparator
description: Patients will receive the same usual care as the experimental group. For the sham massage, the therapist will use one hand to hold the childrens' hand or just put one hand on childrens' body and the other hand will do the manipulations on the therapist's own hand instead childrens' hand or childrens' body. Patients will be required to put on the same kind of cloak as that for the the experimental group, all the manipulations will be done under the cloak. The manipulation times for each acupoints will be the same as those for experimental group in accordance with different age. The sham massage will be given once per day for 3 days continuously.
intervention type: Other
intervention name: Chinese pediatric massage therapy + usual care
arm group label: pediatric massage
intervention type: Other
intervention name: Sham massage therapy + usual care
arm group label: sham massage
criteria: 
gender: All
minimum age: N/A
maximum age: 6 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guangzhou University of Traditional Chinese Medicine
investigator full name: Darong Wu
investigator title: MD, PhD, Director,Program for Outcome Assessment in TCM, Professor, Chief Physician
mesh term: Diarrhea