<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/NCT04454996</url>
  </required_header>
  <id_info>
    <org_study_id>ZZ13-ZD-02</org_study_id>
    <nct_id>NCT04454996</nct_id>
  </id_info>
  <brief_title>Study on the Rule and Mechanism of Treating Functional Gastrointestinal Diseases From the Perspective of Liver and Spleen</brief_title>
  <official_title>Major Achievements in Traditional Chinese Medicine Science and Technology Guidance Projects-Study on the Rule and Mechanism of Treating Functional Gastrointestinal Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xiyuan Hospital of China Academy of Chinese Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xiyuan Hospital of China Academy of Chinese Medical Sciences</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To clarify the changes of intestinal flora - gut - brain axis in FGIDs patients represented&#xD;
      by NERD disharmony of liver and stomach and IBS-D disharmony of liver and spleen, and confirm&#xD;
      that the imbalance between intestinal flora and host co-metabolism is the key to the&#xD;
      pathogenesis of functional gastrointestinal disease. To reveal the common mechanism of&#xD;
      regulating liver and spleen (stomach) in treating FGIDs dynamic disorder and visceral&#xD;
      hypersensitivity by regulating intestinal flora - intestine - brain axis disorder.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">June 25, 2020</start_date>
  <completion_date type="Anticipated">March 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2021</primary_completion_date>
  <phase>Phase 4</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>Changes in 7 point Likert scale scores</measure>
    <time_frame>Baseline, 2 weeks and 4 weeks during treatment period,4 weeks , 8 weeks , 12 weeks and 16 weeks during follow-up period</time_frame>
    <description>The score of patients on the degree of remission of gastroesophageal reflux disease symptoms (acid reflux and heartburn) (1 point for obvious improvement of symptoms, 2 points for improvement of symptoms, 3 points for slight improvement of symptoms, 4 points for no change, 5 points for slight aggravation of symptoms, 6 points for aggravation of symptoms, and 7 points for obvious aggravation of symptoms)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in irritable bowel syndrome symptom severity scale scores</measure>
    <time_frame>Baseline, 2 weeks and 4 weeks during treatment period,4 weeks , 8 weeks , 12 weeks and 16 weeks during follow-up period</time_frame>
    <description>Irritable bowel syndrome symptom severity scale scores were assessed before and after treatment and during follow-up. The scoring standard is the same as the international standard.</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Non-erosive Reflux Disease/Diarrheal Irritable Bowel Syndrome</condition>
  <arm_group>
    <arm_group_label>Non-erosive reflux disease test group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-erosive reflux disease control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Diarrhea-type irritable bowel syndrome test group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group with diarrheal irritable bowel syndrome</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>tong-jiang granules</intervention_name>
    <description>This is a kind of compound Chinese medicine granules, 1 bag each time, 3 times a day, treatment for 4 weeks.</description>
    <arm_group_label>Non-erosive reflux disease test group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chang 'an II Recipe</intervention_name>
    <description>This is Chang 'an II Prescription granule, 1 bag each time, 3 times a day, treatment for 4 weeks.</description>
    <arm_group_label>Diarrhea-type irritable bowel syndrome test group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>The placebo of tong-jiang granules</intervention_name>
    <description>This is a granule, containing 5% tongyu granule active drug,1 bag each time, 3 times a day, treatment for 4 weeks.</description>
    <arm_group_label>Non-erosive reflux disease control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>The placebo of Chang 'an II Recipe</intervention_name>
    <description>This is a granule containing 5% chang 'an II,1 bag each time, 3 times a day, treatment for 4 weeks.</description>
    <arm_group_label>Control group with diarrheal irritable bowel syndrome</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy volunteers with no abnormal clinical manifestations;&#xD;
&#xD;
          2. Meet the diagnostic criteria of NERD syndrome of disharmony of liver and stomach and&#xD;
             IBS-D syndrome of liver depression and spleen deficiency.&#xD;
&#xD;
          3. Aged between 18 and 70.&#xD;
&#xD;
          4. Did not take antibiotics, steroids or other hormones, Chinese herbal preparations&#xD;
             (including oral and intravenous administration), microecological preparations or&#xD;
             probiotics such as yogurt for nearly a week;&#xD;
&#xD;
          5. Subjects are informed and sign informed consent voluntarily;&#xD;
&#xD;
          6. Have certain reading ability.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with severe lesions of the heart, liver, kidney and other major organs,&#xD;
             hematopoietic system, nervous system or mental diseases;&#xD;
&#xD;
          2. Complicated with other organic diseases of the digestive system (such as peptic&#xD;
             ulcer), or systemic diseases that affect the dynamics of the digestive tract (such as&#xD;
             hyperthyroidism and diabetes);&#xD;
&#xD;
          3. Ongoing or ongoing use of drugs that may affect gastrointestinal function&#xD;
             (antidiarrals, antidepressants, anti-anxiety drugs, intestinal microflora regulation&#xD;
             drugs, antibiotics, etc.);&#xD;
&#xD;
          4. Those with a history of allergy to related drugs or severe food allergy used in the&#xD;
             research.&#xD;
&#xD;
          5. The body is colonized with metal medical devices. (6) Having a pregnancy plan within&#xD;
             three months.&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>lin lv</last_name>
    <phone>18811782728</phone>
    <email>lushangshitou@qq.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Xiyuan Hospital of China Academy of Chinese Medical Science</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100091</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>lin lv</last_name>
      <phone>18811782728</phone>
      <email>lushangshitou@qq.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</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>Irritable Bowel Syndrome</mesh_term>
    <mesh_term>Gastrointestinal Diseases</mesh_term>
    <mesh_term>Digestive System Diseases</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/NCT04454996
org study id: ZZ13-ZD-02
nct id: NCT04454996
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
To clarify the changes of intestinal flora - gut - brain axis in FGIDs patients represented
      by NERD disharmony of liver and stomach and IBS-D disharmony of liver and spleen, and confirm
      that the imbalance between intestinal flora and host co-metabolism is the key to the
      pathogenesis of functional gastrointestinal disease. To reveal the common mechanism of
      regulating liver and spleen (stomach) in treating FGIDs dynamic disorder and visceral
      hypersensitivity by regulating intestinal flora - intestine - brain axis disorder.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Changes in 7 point Likert scale scores
time frame: Baseline, 2 weeks and 4 weeks during treatment period,4 weeks , 8 weeks , 12 weeks and 16 weeks during follow-up period
description: The score of patients on the degree of remission of gastroesophageal reflux disease symptoms (acid reflux and heartburn) (1 point for obvious improvement of symptoms, 2 points for improvement of symptoms, 3 points for slight improvement of symptoms, 4 points for no change, 5 points for slight aggravation of symptoms, 6 points for aggravation of symptoms, and 7 points for obvious aggravation of symptoms)
measure: Changes in irritable bowel syndrome symptom severity scale scores
time frame: Baseline, 2 weeks and 4 weeks during treatment period,4 weeks , 8 weeks , 12 weeks and 16 weeks during follow-up period
description: Irritable bowel syndrome symptom severity scale scores were assessed before and after treatment and during follow-up. The scoring standard is the same as the international standard.
arm group label: Non-erosive reflux disease test group
arm group type: Experimental
arm group label: Non-erosive reflux disease control group
arm group type: Placebo Comparator
arm group label: Diarrhea-type irritable bowel syndrome test group
arm group type: Experimental
arm group label: Control group with diarrheal irritable bowel syndrome
arm group type: Placebo Comparator
arm group label: Healthy control group
arm group type: No Intervention
intervention type: Drug
intervention name: tong-jiang granules
description: This is a kind of compound Chinese medicine granules, 1 bag each time, 3 times a day, treatment for 4 weeks.
arm group label: Non-erosive reflux disease test group
intervention type: Drug
intervention name: Chang 'an II Recipe
description: This is Chang 'an II Prescription granule, 1 bag each time, 3 times a day, treatment for 4 weeks.
arm group label: Diarrhea-type irritable bowel syndrome test group
intervention type: Drug
intervention name: The placebo of tong-jiang granules
description: This is a granule, containing 5% tongyu granule active drug,1 bag each time, 3 times a day, treatment for 4 weeks.
arm group label: Non-erosive reflux disease control group
intervention type: Drug
intervention name: The placebo of Chang 'an II Recipe
description: This is a granule containing 5% chang 'an II,1 bag each time, 3 times a day, treatment for 4 weeks.
arm group label: Control group with diarrheal irritable bowel syndrome
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: lin lv
phone: 18811782728
email: lushangshitou@qq.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Irritable Bowel Syndrome
mesh term: Gastrointestinal Diseases
mesh term: Digestive System Diseases