<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/NCT02996604</url>
  </required_header>
  <id_info>
    <org_study_id>15QNJJ0008</org_study_id>
    <secondary_id>81473602</secondary_id>
    <nct_id>NCT02996604</nct_id>
  </id_info>
  <brief_title>Acupuncture for Functional Dyspepsia: a Functional Magnetic Resonance Imaging (fMRI) Study</brief_title>
  <official_title>Acupuncture for Functional Dyspepsia: a Functional Magnetic Resonance Imaging (fMRI) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chengdu University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chengdu University of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      He-Mu-point combination（ST36 and CV12） is one of the most commonly used acupoints combination&#xD;
      with synergistic effect for functional dyspepsia(FD). The investigators design the trial to&#xD;
      identify the efficacy and explore the central integrated mechanism of puncturing at&#xD;
      He-Mu-point combination on FD with functional magnetic resonance imaging (fMRI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      105 participants with functional dyspepsia will be allocated into three groups: Low-He point&#xD;
      group, Mu point group and He-Mu-point combination group.Every participant will receive 20&#xD;
      sessions of manual acupuncture treatment during 4 weeks. Clinical evaluations will be&#xD;
      assessed three times, as measured after randomization, 10 and 20 sessions of treatment.The&#xD;
      fMRI scans will be conducted twice, after randomization and treatment completion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Nepean Dyspepsia Index (NDI)</measure>
    <time_frame>4 weeks after allocation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-Rating Anxiety Scale</measure>
    <time_frame>0 day,2, 4weeks after allocation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Rating Depression Scale</measure>
    <time_frame>0 day,2, 4weeks after allocation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leeds dyspepsia questionnaire</measure>
    <time_frame>0 day,4 weeks after allocation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>brain MRI data</measure>
    <time_frame>0 day,4weeks after allocation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of adverse events during the 4 weeks</measure>
    <time_frame>4weeks after allocation</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Functional Dyspepsia</condition>
  <arm_group>
    <arm_group_label>Low-He point(ST36)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Zusanli (ST36, the Low-He point of stomach) is the most important point for gastrointestinal disorder, including functional dyspepsia. Everyone in the group will be punctured at unilateral Zusanli.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mu point(CV12)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Zhongwan (CV12, the Mu point of stomach) is also good at regulating gastric function. Everyone in the group will be punctured at Zhongwan.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>He-Mu-point combination(ST36 and CV12)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In traditional Chinese acupuncture theory，synergistic effect can be produced by acupoints combination and the He-Mu-point combination is a classical acupoints combination formula for gastrointestinal diseases. Everyone in the group will be punctured at unilateral Zusanli and Zhongwan.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>acupuncture</intervention_name>
    <description>Manual acupuncture treatment will be conducted. thirty minutes duration every time, five times per week for one course, a total four courses.</description>
    <arm_group_label>He-Mu-point combination(ST36 and CV12)</arm_group_label>
    <arm_group_label>Low-He point(ST36)</arm_group_label>
    <arm_group_label>Mu point(CV12)</arm_group_label>
    <other_name>Manual acupuncture</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. right handed，age between 18 and 45 years old, college degree or above;&#xD;
&#xD;
          2. match the Rome III criteria on FD;&#xD;
&#xD;
          3. no local organic disease by gastroscope examination;&#xD;
&#xD;
          4. before entering the study, without taking any prokinetic agents at least 15days and&#xD;
             participating in other clinical study;&#xD;
&#xD;
          5. signing an informed consent in writing by the participant or the immediate family&#xD;
             member.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. consciousness, cannot express subjective symptoms and psychiatric participants;&#xD;
&#xD;
          2. participants with advanced cancer or other serious wasting diseases, easy to be&#xD;
             infected and bleeding;&#xD;
&#xD;
          3. complicating with severe cardiovascular, hepatic,nephritic,digestive, hematopoietic&#xD;
             system diseases;&#xD;
&#xD;
          4. impregnate or lactation female;&#xD;
&#xD;
          5. severe depression and anxiety symptoms;&#xD;
&#xD;
          6. female with serious dysmenorrhea;&#xD;
&#xD;
          7. obvious headache, migraine, history of head injury.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fang Zeng, professor</last_name>
    <role>Study Chair</role>
    <affiliation>Chengdu University of Traditional Chinese Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chengdu University of Traditional Chinese Medicine</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>April 5, 2018</last_update_submitted>
  <last_update_submitted_qc>April 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acupuncture</keyword>
  <keyword>functional dyspepsia</keyword>
  <keyword>functional magnetic resonance imaging (fMRI)</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/NCT02996604
org study id: 15QNJJ0008
secondary id: 81473602
nct id: NCT02996604
lead sponsor: 
has dmc: Yes
He-Mu-point combination（ST36 and CV12） is one of the most commonly used acupoints combination
      with synergistic effect for functional dyspepsia(FD). The investigators design the trial to
      identify the efficacy and explore the central integrated mechanism of puncturing at
      He-Mu-point combination on FD with functional magnetic resonance imaging (fMRI).
105 participants with functional dyspepsia will be allocated into three groups: Low-He point
      group, Mu point group and He-Mu-point combination group.Every participant will receive 20
      sessions of manual acupuncture treatment during 4 weeks. Clinical evaluations will be
      assessed three times, as measured after randomization, 10 and 20 sessions of treatment.The
      fMRI scans will be conducted twice, after randomization and treatment completion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Nepean Dyspepsia Index (NDI)
time frame: 4 weeks after allocation
measure: Self-Rating Anxiety Scale
time frame: 0 day,2, 4weeks after allocation
measure: Self-Rating Depression Scale
time frame: 0 day,2, 4weeks after allocation
measure: Leeds dyspepsia questionnaire
time frame: 0 day,4 weeks after allocation
measure: brain MRI data
time frame: 0 day,4weeks after allocation
measure: The incidence of adverse events during the 4 weeks
time frame: 4weeks after allocation
arm group label: Low-He point(ST36)
arm group type: Experimental
description: Zusanli (ST36, the Low-He point of stomach) is the most important point for gastrointestinal disorder, including functional dyspepsia. Everyone in the group will be punctured at unilateral Zusanli.
arm group label: Mu point(CV12)
arm group type: Experimental
description: Zhongwan (CV12, the Mu point of stomach) is also good at regulating gastric function. Everyone in the group will be punctured at Zhongwan.
arm group label: He-Mu-point combination(ST36 and CV12)
arm group type: Active Comparator
description: In traditional Chinese acupuncture theory，synergistic effect can be produced by acupoints combination and the He-Mu-point combination is a classical acupoints combination formula for gastrointestinal diseases. Everyone in the group will be punctured at unilateral Zusanli and Zhongwan.
intervention type: Other
intervention name: acupuncture
description: Manual acupuncture treatment will be conducted. thirty minutes duration every time, five times per week for one course, a total four courses.
arm group label: He-Mu-point combination(ST36 and CV12)
arm group label: Low-He point(ST36)
arm group label: Mu point(CV12)
other name: Manual acupuncture
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Fang Zeng, professor
role: Study Chair
affiliation: Chengdu University of Traditional Chinese Medicine
facility: 
country: China
responsible party type: Sponsor
mesh term: Dyspepsia