<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/NCT03232528</url>
  </required_header>
  <id_info>
    <org_study_id>promotion</org_study_id>
    <nct_id>NCT03232528</nct_id>
  </id_info>
  <brief_title>The Promotion Plan of Moxibustion on Ulcerate Colitis</brief_title>
  <official_title>A Study on the Promotion Plan of the Moxibustion Treatment of Ulcerate Colitis</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>
  <brief_summary>
    <textblock>
      To evaluate the efficacy of Moxibustion in the treatment of Ulcerative Colitis, thus the&#xD;
      scientific foundation for rational use of Moxibustion in clinical usage, in order to find&#xD;
      admission of the Acupuncture and Moxibustion and even medicine field, accomplish&#xD;
      popularization and application.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 128 patients with UC were randomly divided into the following 2 groups: a)&#xD;
      Herb-partition moxibustion (Treatment Group) and b) Sham herb-partition moxibustion (Control&#xD;
      Group). All patients in the trial will be treated with moxibustion 3 times a week, once a day&#xD;
      for 30 minutes, for a total of 12 weeks. After treating the treatment had ended and the 52nd&#xD;
      week of follow-up to observe the clinical therapy effect of Moxibustion in UC patients.&#xD;
      Tissue morphology and molecular biology tests will be conducted to observe the regulation in&#xD;
      the intestinal mucosa of UC patients. All these steps will be done in order to provide&#xD;
      clinical usage for the effects of herb-partition moxibustion in the treatment of UC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2016</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 30, 2018</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>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>total effective rate</measure>
    <time_frame>3 months</time_frame>
    <description>The curative effect of Herb-partitioned moxibustion for 128 UC patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mayo score</measure>
    <time_frame>6 months</time_frame>
    <description>Assay for the ulcerative colitis desease activity index. It is constructed by four scales, Including stool frequency、rectal bleeding、mucosal appearance at endoscopy and physician rating of disease activity. Every scale can be scored with o ,1 ,2 or 3 according to the activity index of scale. Scores should be compared to previous scores taken for a patient. The higher the score (minimum 0 point and maximum 12 points), the more severe the ulcerative colitis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>symptom score</measure>
    <time_frame>3 months</time_frame>
    <description>Observe the abdominal pain, bloody stool, intolerance of cold, soreness and weakness of waist an knees, diarrhea, mucous stool, tenesmus, anorexia and lassitude score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale(VAS)</measure>
    <time_frame>6 months</time_frame>
    <description>Observe the degree of abdominal pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory Bowel Disease Questionnaire(IBDQ)</measure>
    <time_frame>6 months</time_frame>
    <description>Life quality was determined by the total score of the 32 questions. Each question is given 1-7 different degrees of answer. One represents the heaviest degree and seven represents the lightest degree. The lower the score (minimum 32 points and maximum 224 points), the worse the life quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale(HADS)</measure>
    <time_frame>3 months</time_frame>
    <description>The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 .The higher the total score (minimum 0 point and maximum 21 points), the more severe the anxiety or depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory tests for disease activity: C-reaction protein</measure>
    <time_frame>6 months</time_frame>
    <description>Assay for the quantification of total C-reaction protein in serum.(Normal reference value:&lt;10mg/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory tests for disease activity: Erythrocyte sedimentation rate</measure>
    <time_frame>6 months</time_frame>
    <description>Assay for the quantification of total Erythrocyte sedimentation rate in serum.(Normal reference value: male 0～15mm/h; female 0～20mm/h)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>gut mucosal score under the endoscopy: Baron score;</measure>
    <time_frame>3 months</time_frame>
    <description>evaluate the gut mucosal state by using electronic colonoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mucosal pathology：Geboes score</measure>
    <time_frame>3 months</time_frame>
    <description>Observe the intestinal mucosal tissue changes by HE staining</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety Assessment</measure>
    <time_frame>3 months</time_frame>
    <description>With Administration Events reports record the adverse reaction treatment process, with the moxibustion treatment of safety evaluation. Such as the incidence and severity of scald, skin allergic, vasodepressor syncope etc. Also record subjects's vital signs, consist of body temperature, blood pressure and pulse.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>Herb-partitioned moxibustion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: Herbal cake, Device: Moxibustion. Herbal cakes formula: Monkshood 10g, Cinnamon 2g, Salvia miltiorrhiza 3g, Flos Carthami 3g, Radix Aucklandiae 2g. Herbs are smashed into powder. Every 2.5g medicine powder is mixed with 3g millet wine and then pressed into herbal cakes using a specific mold. Each cake should be 23mm in diameter and 5mm in height. Then, ignited moxa cones are placed on top of each herbal cake. Herbal cakes with moxa cones will be positioned at acupuncture points ST25, ST37 and CV6. The entire treatment will be done once a day for 1 moxa cone every acupuncture point, 30 minutes at a time, 3 times a week, for a total of 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham herb-partitioned moxibustion</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Drug: Herbal cake, Device: Sham moxibustion. Herbal cakes formula: Monkshood 10g, Cinnamon 2g, Salvia miltiorrhiza 3g, Flos Carthami 3g, Radix Aucklandiae 2g. Herbs are smashed into powder. Every 2.5g medicine powder is mixed with 3g millet wine and then pressed into herbal cakes using a specific mold. Each cake should be 23mm in diameter and 5mm in height. Then, ignited moxa cones are placed on top of each herbal cake. Small cardboard sheets with the same size as the herbal cakes will be wrapped with aluminum foil and placed under each herbal cake. These herbal cakes will be positioned at acupuncture points ST25, ST37 and CV6. The entire treatment will be done once a day for 1 moxa cone every acupuncture point, 30 minutes at a time, 3 times a week, for a total of 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Herb-partitioned moxibustion</intervention_name>
    <description>Patients receive herb-partition moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks.</description>
    <arm_group_label>Herb-partitioned moxibustion</arm_group_label>
    <other_name>Treatment Group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham herb-partitioned moxibustion</intervention_name>
    <description>Patients receive sham herb-partition moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks.</description>
    <arm_group_label>Sham herb-partitioned moxibustion</arm_group_label>
    <other_name>Control Group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meet the diagnosis of UC&#xD;
&#xD;
          -  Patients do not receive any medicine, or if they are receiving medicine, it should be&#xD;
             aminosalicylates and/or prednisone (dose ≤15mg and have taken at least 1 month);&#xD;
&#xD;
          -  Patients should have not received antibiotic, biologicals within 3 months prior to&#xD;
             entering the study;&#xD;
&#xD;
          -  Signing a written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with cardiac, encephalic, hepatic, nephric, hematopoietic system, psychotic&#xD;
             or any other serious diseases;&#xD;
&#xD;
          -  Pregnancy or lactation;&#xD;
&#xD;
          -  genetic family history of nervous system disease&#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>Huangan Wu, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>Shanghai Institute of Acupuncture-Moxibustion and Meridian, Shanghai University of Traditional Chinese Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Research Insititute of Acupuncture and Meridian</name>
      <address>
        <city>Shanghai</city>
        <state>Xuhui</state>
        <zip>20000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>March 17, 2021</last_update_submitted>
  <last_update_submitted_qc>March 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colitis</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/NCT03232528
org study id: promotion
nct id: NCT03232528
lead sponsor: 
To evaluate the efficacy of Moxibustion in the treatment of Ulcerative Colitis, thus the
      scientific foundation for rational use of Moxibustion in clinical usage, in order to find
      admission of the Acupuncture and Moxibustion and even medicine field, accomplish
      popularization and application.
A total of 128 patients with UC were randomly divided into the following 2 groups: a)
      Herb-partition moxibustion (Treatment Group) and b) Sham herb-partition moxibustion (Control
      Group). All patients in the trial will be treated with moxibustion 3 times a week, once a day
      for 30 minutes, for a total of 12 weeks. After treating the treatment had ended and the 52nd
      week of follow-up to observe the clinical therapy effect of Moxibustion in UC patients.
      Tissue morphology and molecular biology tests will be conducted to observe the regulation in
      the intestinal mucosa of UC patients. All these steps will be done in order to provide
      clinical usage for the effects of herb-partition moxibustion in the treatment of UC.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: total effective rate
time frame: 3 months
description: The curative effect of Herb-partitioned moxibustion for 128 UC patients.
measure: Mayo score
time frame: 6 months
description: Assay for the ulcerative colitis desease activity index. It is constructed by four scales, Including stool frequency、rectal bleeding、mucosal appearance at endoscopy and physician rating of disease activity. Every scale can be scored with o ,1 ,2 or 3 according to the activity index of scale. Scores should be compared to previous scores taken for a patient. The higher the score (minimum 0 point and maximum 12 points), the more severe the ulcerative colitis.
measure: symptom score
time frame: 3 months
description: Observe the abdominal pain, bloody stool, intolerance of cold, soreness and weakness of waist an knees, diarrhea, mucous stool, tenesmus, anorexia and lassitude score.
measure: Visual Analogue Scale(VAS)
time frame: 6 months
description: Observe the degree of abdominal pain
measure: Inflammatory Bowel Disease Questionnaire(IBDQ)
time frame: 6 months
description: Life quality was determined by the total score of the 32 questions. Each question is given 1-7 different degrees of answer. One represents the heaviest degree and seven represents the lightest degree. The lower the score (minimum 32 points and maximum 224 points), the worse the life quality.
measure: Hospital Anxiety and Depression Scale(HADS)
time frame: 3 months
description: The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 .The higher the total score (minimum 0 point and maximum 21 points), the more severe the anxiety or depression.
measure: Laboratory tests for disease activity: C-reaction protein
time frame: 6 months
description: Assay for the quantification of total C-reaction protein in serum.(Normal reference value:<10mg/L)
measure: Laboratory tests for disease activity: Erythrocyte sedimentation rate
time frame: 6 months
description: Assay for the quantification of total Erythrocyte sedimentation rate in serum.(Normal reference value: male 0～15mm/h; female 0～20mm/h)
measure: gut mucosal score under the endoscopy: Baron score;
time frame: 3 months
description: evaluate the gut mucosal state by using electronic colonoscopy
measure: mucosal pathology：Geboes score
time frame: 3 months
description: Observe the intestinal mucosal tissue changes by HE staining
measure: Safety Assessment
time frame: 3 months
description: With Administration Events reports record the adverse reaction treatment process, with the moxibustion treatment of safety evaluation. Such as the incidence and severity of scald, skin allergic, vasodepressor syncope etc. Also record subjects's vital signs, consist of body temperature, blood pressure and pulse.
arm group label: Herb-partitioned moxibustion
arm group type: Experimental
description: Drug: Herbal cake, Device: Moxibustion. Herbal cakes formula: Monkshood 10g, Cinnamon 2g, Salvia miltiorrhiza 3g, Flos Carthami 3g, Radix Aucklandiae 2g. Herbs are smashed into powder. Every 2.5g medicine powder is mixed with 3g millet wine and then pressed into herbal cakes using a specific mold. Each cake should be 23mm in diameter and 5mm in height. Then, ignited moxa cones are placed on top of each herbal cake. Herbal cakes with moxa cones will be positioned at acupuncture points ST25, ST37 and CV6. The entire treatment will be done once a day for 1 moxa cone every acupuncture point, 30 minutes at a time, 3 times a week, for a total of 12 weeks.
arm group label: Sham herb-partitioned moxibustion
arm group type: Sham Comparator
description: Drug: Herbal cake, Device: Sham moxibustion. Herbal cakes formula: Monkshood 10g, Cinnamon 2g, Salvia miltiorrhiza 3g, Flos Carthami 3g, Radix Aucklandiae 2g. Herbs are smashed into powder. Every 2.5g medicine powder is mixed with 3g millet wine and then pressed into herbal cakes using a specific mold. Each cake should be 23mm in diameter and 5mm in height. Then, ignited moxa cones are placed on top of each herbal cake. Small cardboard sheets with the same size as the herbal cakes will be wrapped with aluminum foil and placed under each herbal cake. These herbal cakes will be positioned at acupuncture points ST25, ST37 and CV6. The entire treatment will be done once a day for 1 moxa cone every acupuncture point, 30 minutes at a time, 3 times a week, for a total of 12 weeks.
intervention type: Other
intervention name: Herb-partitioned moxibustion
description: Patients receive herb-partition moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks.
arm group label: Herb-partitioned moxibustion
other name: Treatment Group
intervention type: Other
intervention name: Sham herb-partitioned moxibustion
description: Patients receive sham herb-partition moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks.
arm group label: Sham herb-partitioned moxibustion
other name: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Huangan Wu, Doctor
role: Study Director
affiliation: Shanghai Institute of Acupuncture-Moxibustion and Meridian, Shanghai University of Traditional Chinese Medicine
facility: 
country: China
responsible party type: Sponsor
mesh term: Colitis