<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/NCT01671670</url>
  </required_header>
  <id_info>
    <org_study_id>2012CB518501-3</org_study_id>
    <secondary_id>2012CB518501</secondary_id>
    <nct_id>NCT01671670</nct_id>
  </id_info>
  <brief_title>Acupuncture for Patients With Function Dyspepsia</brief_title>
  <official_title>Phase III Study of Acupuncture for Patients With Functional Dyspepsia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chengdu University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hunan University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chengdu University of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypothesis: Acupuncture is efficacious and safe for patients with functional dyspepsia&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  A single blind randomized controlled trial&#xD;
&#xD;
        -  200 participants will be included&#xD;
&#xD;
        -  Two arms: acupuncture and sham acupuncture group&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim: to clarify the efficacy and safety of acupuncture for patients with functional dyspepsia&#xD;
      Design: A single blind randomized controlled trial will be performed in Chengdu, Hunan and&#xD;
      Chongqing province. Two hundred participants will be randomly assign to acupuncture and sham&#xD;
      acupuncture group. Each participants will receive 20 sessions of acupuncture in 4 weeks, with&#xD;
      a duration of 30 minutes in a session. The primary outcome is Patients' global assessments of&#xD;
      efficacy in 16 weeks after inclusion. Secondary outcomes include validated Leeds Dyspepsia&#xD;
      Questionnaire, Nepean dyspepsia index, etc.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of participants reporting complete absence of dyspeptic symptoms</measure>
    <time_frame>at 16 weeks after inclusion</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>validated Leeds Dyspepsia Questionnaire</measure>
    <time_frame>4, 8, 16, 20, 24 weeks after inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nepean dyspepsia index</measure>
    <time_frame>4, 8, 16, 20, 24 weeks after inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse events in each group</measure>
    <time_frame>4 weeks after inclusion</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Functional Dyspepsia</condition>
  <condition>Postprandial Distress Syndrome</condition>
  <arm_group>
    <arm_group_label>acupuncture group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>use traditional acupuncture to treat functional dyspepsia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham acupuncture group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>use penetrating sham acupuncture to manage functional dyspepsia</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>acupuncture</intervention_name>
    <description>In this group, acupuncture is given according to traditional acupuncture theories.</description>
    <arm_group_label>acupuncture group</arm_group_label>
    <other_name>use hwato acupuncture needles</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>sham acupuncture</intervention_name>
    <description>Sham acupuncture points will be used in this trial, with needle penetration.</description>
    <arm_group_label>sham acupuncture group</arm_group_label>
    <other_name>verum acupuncture</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consistent with the diagnostic criteria of functional dyspepsia.&#xD;
&#xD;
          -  Age of a subject is older than 18 and is younger than 65.（including 18 and 65）&#xD;
&#xD;
          -  Include postprandial distress syndrome.&#xD;
&#xD;
          -  Did not take any gastroenteric dynamic drugs in the last 15 days, and did not take&#xD;
             part in any clinical trial.&#xD;
&#xD;
          -  Informed consent is signed by a subject or his lineal relation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with any contraindications of Itopride.&#xD;
&#xD;
          -  Patients who are unconscious, psychotic.&#xD;
&#xD;
          -  Patients with aggravating tumor and other serious consumptive disease, and who are&#xD;
             subject to infection and bleeding.&#xD;
&#xD;
          -  With serious protopathy or disease of cardiovascular, liver, renal, gastrointestinal,&#xD;
             hematological systems and so on.&#xD;
&#xD;
          -  Pregnant women or women in lactation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fan-rong Liang, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Chengdu University of TCM</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chengdu University of TCM</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610075</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Ma TT, Yu SY, Li Y, Liang FR, Tian XP, Zheng H, Yan J, Sun GJ, Chang XR, Zhao L, Wu X, Zeng F. Randomised clinical trial: an assessment of acupuncture on specific meridian or specific acupoint vs. sham acupuncture for treating functional dyspepsia. Aliment Pharmacol Ther. 2012 Mar;35(5):552-61. doi: 10.1111/j.1365-2036.2011.04979.x. Epub 2012 Jan 16.</citation>
    <PMID>22243034</PMID>
  </reference>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>November 25, 2014</last_update_submitted>
  <last_update_submitted_qc>November 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Functional dyspepsia</keyword>
  <keyword>postprandial distress syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyspepsia</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/NCT01671670
org study id: 2012CB518501-3
secondary id: 2012CB518501
nct id: NCT01671670
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Hypothesis: Acupuncture is efficacious and safe for patients with functional dyspepsia

      Design:

        -  A single blind randomized controlled trial

        -  200 participants will be included

        -  Two arms: acupuncture and sham acupuncture group
Aim: to clarify the efficacy and safety of acupuncture for patients with functional dyspepsia
      Design: A single blind randomized controlled trial will be performed in Chengdu, Hunan and
      Chongqing province. Two hundred participants will be randomly assign to acupuncture and sham
      acupuncture group. Each participants will receive 20 sessions of acupuncture in 4 weeks, with
      a duration of 30 minutes in a session. The primary outcome is Patients' global assessments of
      efficacy in 16 weeks after inclusion. Secondary outcomes include validated Leeds Dyspepsia
      Questionnaire, Nepean dyspepsia index, etc.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: The proportion of participants reporting complete absence of dyspeptic symptoms
time frame: at 16 weeks after inclusion
measure: validated Leeds Dyspepsia Questionnaire
time frame: 4, 8, 16, 20, 24 weeks after inclusion
measure: Nepean dyspepsia index
time frame: 4, 8, 16, 20, 24 weeks after inclusion
measure: adverse events in each group
time frame: 4 weeks after inclusion
arm group label: acupuncture group
arm group type: Experimental
description: use traditional acupuncture to treat functional dyspepsia
arm group label: sham acupuncture group
arm group type: Sham Comparator
description: use penetrating sham acupuncture to manage functional dyspepsia
intervention type: Other
intervention name: acupuncture
description: In this group, acupuncture is given according to traditional acupuncture theories.
arm group label: acupuncture group
other name: use hwato acupuncture needles
intervention type: Other
intervention name: sham acupuncture
description: Sham acupuncture points will be used in this trial, with needle penetration.
arm group label: sham acupuncture group
other name: verum acupuncture
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fan-rong Liang, MD
role: Study Chair
affiliation: Chengdu University of TCM
facility: 
country: China
citation: Ma TT, Yu SY, Li Y, Liang FR, Tian XP, Zheng H, Yan J, Sun GJ, Chang XR, Zhao L, Wu X, Zeng F. Randomised clinical trial: an assessment of acupuncture on specific meridian or specific acupoint vs. sham acupuncture for treating functional dyspepsia. Aliment Pharmacol Ther. 2012 Mar;35(5):552-61. doi: 10.1111/j.1365-2036.2011.04979.x. Epub 2012 Jan 16.
PMID: 22243034
responsible party type: Sponsor
mesh term: Dyspepsia