<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/NCT01696838</url>
  </required_header>
  <id_info>
    <org_study_id>SHACU-201201</org_study_id>
    <nct_id>NCT01696838</nct_id>
  </id_info>
  <brief_title>Efficacy of Acupuncture and Moxibustion Treatment in Patients With Quiescent Crohn's Disease:Evaluation With fMRI</brief_title>
  <official_title>Efficacy of Acupuncture and Moxibustion Treatment in Patients With Quiescent Crohn's Disease:Evaluation With Functional Magnetic Resonance Imaging(fMRI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Institute of Acupuncture, Moxibustion and Meridian</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Institute of Acupuncture, Moxibustion and Meridian</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether acupuncture or moxibustion therapies are&#xD;
      effective in the treatment of Crohn's disease. Meanwhile, the investigators aim to evaluate&#xD;
      the efficacy by functional magnetic resonance imaging.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine whether acupuncture or moxibustion therapies are&#xD;
      effective in the treatment of Crohn's disease. meanwhile, the investigators aim to evaluate&#xD;
      the efficacy by functional magnetic resonance imaging.&#xD;
&#xD;
      Through treating quiescent Crohn's disease by electroacupuncture or moxibustion therapies for&#xD;
      12 weeks, Compare the different brain activation by the different therapies and observe the&#xD;
      correlation between brain activation and efficacy.&#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">April 2014</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 (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CDAI</measure>
    <time_frame>1 year</time_frame>
    <description>Crohn's Disease Activity Index</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>fMRI</measure>
    <time_frame>1 year</time_frame>
    <description>Brain activiation tested by BOLD fMRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IBDQ</measure>
    <time_frame>1 year</time_frame>
    <description>Inflammatory Bowel Disease Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory factors</measure>
    <time_frame>1 and a half years</time_frame>
    <description>Intestinal mucosa of IL-6,IL-17,IL-23,etc</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurotransmitter</measure>
    <time_frame>1 and a half years</time_frame>
    <description>5-HT,DA,etc</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Crohn's Disease</condition>
  <condition>CAM</condition>
  <arm_group>
    <arm_group_label>EA group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Electroacupuncture group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MOX group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Herbs-partitioned moxibustion group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>electroacupuncture</intervention_name>
    <description>Patients receive electroacupuncture for 30 minutes with a stimulation frequency of 2 /100 Hz and a stimulation intensity varying from 0.1 to 1.0 mA.3 times per week,the duration is 12 weeks.</description>
    <arm_group_label>EA group</arm_group_label>
    <arm_group_label>MOX group</arm_group_label>
    <other_name>acupuncture</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>moxibustion</intervention_name>
    <description>patients receive herbs-partitioned moxibustion for 2 cones，3 times a week for 12 weeks.</description>
    <arm_group_label>EA group</arm_group_label>
    <arm_group_label>MOX group</arm_group_label>
    <other_name>herbs-partitioned moxibustion</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18-50 years;&#xD;
&#xD;
          -  right-handed;&#xD;
&#xD;
          -  clinical remission (Crohn's Disease Activity Index [CDAI]≤150) for at least 6 months&#xD;
             prior to the study;&#xD;
&#xD;
          -  C-reactive protein(CRP)&lt;10 mg/l;&#xD;
&#xD;
          -  erythrocyte sedimentation rate (ESR) &lt;20 mm/h&#xD;
&#xD;
          -  signing awritten informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  use of corticosteroids and psychotropic medications in the previous 30 days;&#xD;
&#xD;
          -  current or prior history of neurological or psychiatric disease based&#xD;
&#xD;
          -  on physicians' examination and questionnaires;&#xD;
&#xD;
          -  current or prior history of neurosurgery, head injury, cerebrovascular&#xD;
&#xD;
          -  insult, or brain trauma involving loss of consciousness;&#xD;
&#xD;
          -  learning disability;&#xD;
&#xD;
          -  claustrophobia;&#xD;
&#xD;
          -  presence of metallic implants in the body;&#xD;
&#xD;
          -  being pregnant or during lactation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wu Huangan, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Shanghai Institute of Acupuncture, Moxibustion and Meridian</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Institute of Acupuncture-Moxibustion and Merdian</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <last_update_submitted>September 2, 2016</last_update_submitted>
  <last_update_submitted_qc>September 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Crohn's disease</keyword>
  <keyword>acupuncture</keyword>
  <keyword>moxibustion</keyword>
  <keyword>fMRI</keyword>
  <keyword>Gut</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</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/NCT01696838
org study id: SHACU-201201
nct id: NCT01696838
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether acupuncture or moxibustion therapies are
      effective in the treatment of Crohn's disease. Meanwhile, the investigators aim to evaluate
      the efficacy by functional magnetic resonance imaging.
The purpose of this study is to determine whether acupuncture or moxibustion therapies are
      effective in the treatment of Crohn's disease. meanwhile, the investigators aim to evaluate
      the efficacy by functional magnetic resonance imaging.

      Through treating quiescent Crohn's disease by electroacupuncture or moxibustion therapies for
      12 weeks, Compare the different brain activation by the different therapies and observe the
      correlation between brain activation and efficacy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: CDAI
time frame: 1 year
description: Crohn's Disease Activity Index
measure: fMRI
time frame: 1 year
description: Brain activiation tested by BOLD fMRI
measure: IBDQ
time frame: 1 year
description: Inflammatory Bowel Disease Questionnaire
measure: Inflammatory factors
time frame: 1 and a half years
description: Intestinal mucosa of IL-6,IL-17,IL-23,etc
measure: Neurotransmitter
time frame: 1 and a half years
description: 5-HT,DA,etc
arm group label: EA group
arm group type: Experimental
description: Electroacupuncture group
arm group label: MOX group
arm group type: Experimental
description: Herbs-partitioned moxibustion group
intervention type: Other
intervention name: electroacupuncture
description: Patients receive electroacupuncture for 30 minutes with a stimulation frequency of 2 /100 Hz and a stimulation intensity varying from 0.1 to 1.0 mA.3 times per week,the duration is 12 weeks.
arm group label: EA group
arm group label: MOX group
other name: acupuncture
intervention type: Other
intervention name: moxibustion
description: patients receive herbs-partitioned moxibustion for 2 cones，3 times a week for 12 weeks.
arm group label: EA group
arm group label: MOX group
other name: herbs-partitioned moxibustion
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Wu Huangan, PhD
role: Study Chair
affiliation: Shanghai Institute of Acupuncture, Moxibustion and Meridian
facility: 
country: China
responsible party type: Sponsor
mesh term: Crohn Disease