<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/NCT01697761</url>
  </required_header>
  <id_info>
    <org_study_id>SHACU-201202</org_study_id>
    <nct_id>NCT01697761</nct_id>
  </id_info>
  <brief_title>Efficacy of Acupuncture and Moxibustion Treatment in Patients With Active Crohn's Disease</brief_title>
  <official_title>Efficacy of Acupuncture and Moxibustion Treatment in Patients With Active Crohn's Disease and Its Regulation Mechanism to the Immune Homeostasis Mediated by Th17/Treg Cells</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 active Crohn's disease. meanwhile, we are aim to observe the&#xD;
      content of Inflammatory factors and Neurotransmitter before and after acupuncture and&#xD;
      moxibustion therapy.&#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 active Crohn's disease. meanwhile, we are aim to observe the&#xD;
      content of Inflammatory factors and Neurotransmitter before and after acupuncture and&#xD;
      moxibustion therapy.&#xD;
&#xD;
      Through treating active Crohn's disease by acupuncture and moxibustion therapies for 12&#xD;
      weeks, we are aim to observe the efficiency and the probably change of Inflammatory factors&#xD;
      and Neurotransmitter of colonic mucosa and we may elucidate the mechanism of the efficiency&#xD;
      of acupuncture and moxibustion therapy.&#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">August 2013</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>2 years</time_frame>
    <description>Crohn's Disease Activity Index</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inflammatory factors</measure>
    <time_frame>2 years</time_frame>
    <description>Intestinal mucosa of Th17/Treg,IL-6,IL-17,IL-23,etc</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurotransmitter</measure>
    <time_frame>2 years</time_frame>
    <description>Intestinal mucosa of 5-HT,DA,SP,VIP and their receptors etc</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IBDQ</measure>
    <time_frame>2 years</time_frame>
    <description>Inflammatory Bowel Disease Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">92</enrollment>
  <condition>Crohn's Disease</condition>
  <condition>CAM</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>treat by moxibustion and acupuncture</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>treat by Sham acupuncture and moxibustion</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment Group</intervention_name>
    <description>patients receive herbs-partitioned moxibustion for 2 cones and acupuncture for 30 minutes，3 times a week for 12 weeks</description>
    <arm_group_label>Treatment Group</arm_group_label>
    <other_name>acupuncture and moxibustion group</other_name>
    <other_name>acupuncture and Herbs-partitioned moxibustion group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control Group</intervention_name>
    <description>patients receive shallow needing and bran-partitioned moxibustion with the stimulation same to the treatment group.</description>
    <arm_group_label>Control Group</arm_group_label>
    <other_name>Sham acupuncture and moxibustion group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18-70 years;&#xD;
&#xD;
          -  Crohn's Disease Activity Index [CDAI]&gt;150 and &lt;450;&#xD;
&#xD;
          -  not taking any medication or taking salicylates, prednisone ( dose≤ 15mg and at least&#xD;
             have taken a month ), after entering the study the dose remained constant;&#xD;
&#xD;
          -  Not taking immunosuppressive agents or use &quot; with &quot; biological preparations within 3&#xD;
             months prior to entering the study&#xD;
&#xD;
          -  signing a written informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe Crohn's disease patients or patients in remission ( CDAI &gt; 450 or &lt; 150 );&#xD;
&#xD;
          -  The pregnancy or lactation period patients ;&#xD;
&#xD;
          -  patients associated with heart, brain, liver, kidney and hematopoietic system disease;&#xD;
&#xD;
          -  The psychiatric patients;&#xD;
&#xD;
          -  Patients with other serious diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</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 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>November 19, 2014</last_update_submitted>
  <last_update_submitted_qc>November 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Crohn's disease,acupuncture,moxibustion,inflammation factors</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/NCT01697761
org study id: SHACU-201202
nct id: NCT01697761
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether acupuncture or moxibustion therapies are
      effective in the treatment of active Crohn's disease. meanwhile, we are aim to observe the
      content of Inflammatory factors and Neurotransmitter before and after acupuncture and
      moxibustion therapy.
The purpose of this study is to determine whether acupuncture or moxibustion therapies are
      effective in the treatment of active Crohn's disease. meanwhile, we are aim to observe the
      content of Inflammatory factors and Neurotransmitter before and after acupuncture and
      moxibustion therapy.

      Through treating active Crohn's disease by acupuncture and moxibustion therapies for 12
      weeks, we are aim to observe the efficiency and the probably change of Inflammatory factors
      and Neurotransmitter of colonic mucosa and we may elucidate the mechanism of the efficiency
      of acupuncture and moxibustion therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: CDAI
time frame: 2 years
description: Crohn's Disease Activity Index
measure: Inflammatory factors
time frame: 2 years
description: Intestinal mucosa of Th17/Treg,IL-6,IL-17,IL-23,etc
measure: Neurotransmitter
time frame: 2 years
description: Intestinal mucosa of 5-HT,DA,SP,VIP and their receptors etc
measure: IBDQ
time frame: 2 years
description: Inflammatory Bowel Disease Questionnaire
arm group label: Treatment Group
arm group type: Experimental
description: treat by moxibustion and acupuncture
arm group label: Control Group
arm group type: Experimental
description: treat by Sham acupuncture and moxibustion
intervention type: Other
intervention name: Treatment Group
description: patients receive herbs-partitioned moxibustion for 2 cones and acupuncture for 30 minutes，3 times a week for 12 weeks
arm group label: Treatment Group
other name: acupuncture and moxibustion group
other name: acupuncture and Herbs-partitioned moxibustion group
intervention type: Other
intervention name: Control Group
description: patients receive shallow needing and bran-partitioned moxibustion with the stimulation same to the treatment group.
arm group label: Control Group
other name: Sham acupuncture and moxibustion group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
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