<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/NCT04449887</url>
  </required_header>
  <id_info>
    <org_study_id>ZZ13-YQ-006</org_study_id>
    <nct_id>NCT04449887</nct_id>
  </id_info>
  <brief_title>The Role of Intestinal Flora in the Pathogenesis of FD and the Intervention of Xiangsha Liujunzi</brief_title>
  <official_title>The Role of Intestinal Flora in the Pathogenesis of FD and the Intervention of Xiangsha Liujunzi</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>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Functional dyspepsia (FD) is a common digestive system disease in clinic. Although it has not&#xD;
      reached the level of life-threatening, it seriously affects the quality of life of patients.&#xD;
      The pathogenesis of FD mainly involves gastric motility disorder and visceral&#xD;
      hypersensitivity. At present, there are gastric motility promoting drugs and gastric acid&#xD;
      inhibiting drugs, but they can not achieve satisfactory therapeutic effect. Traditional&#xD;
      Chinese medicine has a good clinical effect on FD, but the specific mechanism is not clear.&#xD;
      With the gradual deepening of intestinal flora research, it provides a useful tool for&#xD;
      elucidating the mechanism of action of traditional Chinese medicine compound. The role of&#xD;
      intestinal flora in the pathogenesis of FD, especially in the pathogenesis of symptoms, has&#xD;
      not been studied, and the mechanism of Spleen-strengthening and motility-promoting effects of&#xD;
      Xiangsha Liujun has not been studied from the perspective of intestinal flora. In this study,&#xD;
      16S rRNA high-throughput sequencing technology was used to observe the difference of&#xD;
      intestinal flora between FD patients and normal people, and then to observe the effect of&#xD;
      Xiangsha Liujun on intestinal flora of FD patients. The aim of this study was to explore the&#xD;
      role of intestinal flora in the pathogenesis of FD and to elucidate the therapeutic mechanism&#xD;
      of Xiangsha Liujunzi by regulating intestinal flora of FD patients, so as to provide support&#xD;
      for follow-up clinical and experimental studies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">July 7, 2020</start_date>
  <completion_date type="Anticipated">August 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>General impression scale</measure>
    <time_frame>4 weeks</time_frame>
    <description>Significant deterioration, slight deterioration, no remission, slight remission,significant remission, complete remission.Change from baseline on different levels at 4 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptom severity scale</measure>
    <time_frame>4 weeks</time_frame>
    <description>early satiety,upper abdominal pain, postprandial fullness discomfort,Burning sensation of upper abdomen.Change from baseline on symptom severity scale at 4 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SF-36 scale</measure>
    <time_frame>4 weeks</time_frame>
    <description>Eight dimensions: physiological function, social function, physiological function, physical pain, mental health, emotional function, vitality, overall health.Change from baseline on every dimension at 4 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TCM symptom score (TCMSS)</measure>
    <time_frame>4 weeks</time_frame>
    <description>15 items: fullness of ruffles, epigastralgia, stupor, heartburn or burning sensation, belching and acid regurgitation, salivation clearing, pharyngeal obstruction, thirsty but not willing to drink water, less abdominal distention and pain, weakness of limbs, shortness of breath, laziness, heavy sleepiness of the whole body and limbs, fear of cold and cold, loose stools.Change from baseline on TCM symptom score (TCMSS) at 4 weeks.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Functional Dyspepsia</condition>
  <arm_group>
    <arm_group_label>The treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects in this group were treated with Xiangsha Liujunzi granule for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Xiangsha Liujunzi granules</intervention_name>
    <description>A traditional Chinese medicine compound, taken three times a day, one bag at a time, for a total of 28 days</description>
    <arm_group_label>The treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of functional dyspepsia by Rome IV . ② Clinical diagnosis of spleen&#xD;
             deficiency and qi stagnation by CTM. ③ Must be able to swallow potion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gastric ulcer&#xD;
&#xD;
               -  Duodenal ulcer.&#xD;
&#xD;
                    -  Gastroesophageal reflux disease .&#xD;
&#xD;
                         -  Chronic gastritis with HP (+).&#xD;
&#xD;
                              -  Chronic pancreatitis.&#xD;
&#xD;
                                   -  Diabetes.&#xD;
&#xD;
                                        -  Chronic renal insufficiency.&#xD;
&#xD;
                                             -  Hematological disease.&#xD;
&#xD;
                                                  -  tumor or AIDS.&#xD;
&#xD;
                                                       -  Pregnant or lactating women.&#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_contact>
    <last_name>Lv Lin, Doctor</last_name>
    <phone>010-62835641</phone>
    <email>lushangshitou@qq.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Digestive department of Xi Yuan Hospital of China Academy of Chinese Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100091</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lv Lin, Doctor</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>xiangshaliujunzi,functional dyspepsia，Intestinal flora</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/NCT04449887
org study id: ZZ13-YQ-006
nct id: NCT04449887
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Functional dyspepsia (FD) is a common digestive system disease in clinic. Although it has not
      reached the level of life-threatening, it seriously affects the quality of life of patients.
      The pathogenesis of FD mainly involves gastric motility disorder and visceral
      hypersensitivity. At present, there are gastric motility promoting drugs and gastric acid
      inhibiting drugs, but they can not achieve satisfactory therapeutic effect. Traditional
      Chinese medicine has a good clinical effect on FD, but the specific mechanism is not clear.
      With the gradual deepening of intestinal flora research, it provides a useful tool for
      elucidating the mechanism of action of traditional Chinese medicine compound. The role of
      intestinal flora in the pathogenesis of FD, especially in the pathogenesis of symptoms, has
      not been studied, and the mechanism of Spleen-strengthening and motility-promoting effects of
      Xiangsha Liujun has not been studied from the perspective of intestinal flora. In this study,
      16S rRNA high-throughput sequencing technology was used to observe the difference of
      intestinal flora between FD patients and normal people, and then to observe the effect of
      Xiangsha Liujun on intestinal flora of FD patients. The aim of this study was to explore the
      role of intestinal flora in the pathogenesis of FD and to elucidate the therapeutic mechanism
      of Xiangsha Liujunzi by regulating intestinal flora of FD patients, so as to provide support
      for follow-up clinical and experimental studies.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: General impression scale
time frame: 4 weeks
description: Significant deterioration, slight deterioration, no remission, slight remission,significant remission, complete remission.Change from baseline on different levels at 4 weeks.
measure: Symptom severity scale
time frame: 4 weeks
description: early satiety,upper abdominal pain, postprandial fullness discomfort,Burning sensation of upper abdomen.Change from baseline on symptom severity scale at 4 weeks.
measure: SF-36 scale
time frame: 4 weeks
description: Eight dimensions: physiological function, social function, physiological function, physical pain, mental health, emotional function, vitality, overall health.Change from baseline on every dimension at 4 weeks.
measure: TCM symptom score (TCMSS)
time frame: 4 weeks
description: 15 items: fullness of ruffles, epigastralgia, stupor, heartburn or burning sensation, belching and acid regurgitation, salivation clearing, pharyngeal obstruction, thirsty but not willing to drink water, less abdominal distention and pain, weakness of limbs, shortness of breath, laziness, heavy sleepiness of the whole body and limbs, fear of cold and cold, loose stools.Change from baseline on TCM symptom score (TCMSS) at 4 weeks.
arm group label: The treatment group
arm group type: Experimental
description: The subjects in this group were treated with Xiangsha Liujunzi granule for 4 weeks
intervention type: Drug
intervention name: Xiangsha Liujunzi granules
description: A traditional Chinese medicine compound, taken three times a day, one bag at a time, for a total of 28 days
arm group label: The treatment group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lv Lin, Doctor
phone: 010-62835641
email: lushangshitou@qq.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Dyspepsia