<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/NCT03823248</url>
  </required_header>
  <id_info>
    <org_study_id>2017YFC1700601</org_study_id>
    <nct_id>NCT03823248</nct_id>
  </id_info>
  <brief_title>Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion</brief_title>
  <official_title>Therapeutic Mechanism of Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion：A Multi-center, Randomized and Controlled Experiment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xiyuan Hospital of China Academy of Chinese Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Guangdong Provincial Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuhan Integrated Traditional Chinese and Western Medicine Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Traditional Chinese Medicine Hospital of KUNSHAN</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yueyang Hospital of Integrated Traditional Chinese and Western Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Xiyuan Hospital of China Academy of Chinese Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study had adopted the multi-center, randomized and controlled experiment design based on&#xD;
      standardized mucosal biopsy and pathohistological operation, as well as therapeutic&#xD;
      evaluation methodology. Meanwhile, patients diagnosed with chronic atrophic gastritis&#xD;
      accompanying with low grade intraepithelial neoplasia and indefinite dysphasia (grade C2/C3&#xD;
      of Vienna classification) confirmed by gastroscopic histopathology were enrolled as the&#xD;
      objects of study, while folic acid was used as the control. The therapeutic effect and safety&#xD;
      of Jianpi Huoxue Recipe (Moluodan + Sanchi powder) in intervening the gastric Premalignant&#xD;
      lesion were evaluated from the points of view of pathology, gastroscopy and symptoms. The&#xD;
      elimination rate of intraepithelial neoplasia of gastric mucosa was expected to be improved&#xD;
      by 9-12%. Moreover, high quality evidence-based medical evidence regarding traditional&#xD;
      Chinese medicine (TCM) in intervening gastric Premalignant lesion would be obtained, which&#xD;
      could form the mature, propagable and effective scheme.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intraepithelial neoplasia of gastric mucosa is a well-recognized gastric Premalignant lesion,&#xD;
      which is the key of secondary prevention for gastric cancer. However, no universally&#xD;
      acknowledged effective therapeutic scheme is available at present. Previously, the&#xD;
      investigator's research group has carried out clinical trial study based on solving the key&#xD;
      problems such as diagnostic criteria, mucosal biopsy consistency and therapeutic evaluation&#xD;
      methodology, and has attained certain achievements. This study had adopted the multi-center,&#xD;
      randomized and controlled experiment design based on standardized mucosal biopsy and&#xD;
      pathohistological operation, as well as therapeutic evaluation methodology. Meanwhile,&#xD;
      patients diagnosed with chronic atrophic gastritis accompanying with low grade&#xD;
      intraepithelial neoplasia and indefinite dysphasia (grade C2/C3 of Vienna classification)&#xD;
      confirmed by gastroscopic histopathology were enrolled as the objects of study, while folic&#xD;
      acid was used as the control. The therapeutic effect and safety of Jianpi Huoxue Recipe&#xD;
      (Moluodan + Sanchi powder) in intervening the gastric Premalignant lesion were evaluated from&#xD;
      the points of view of pathology, gastroscopy and symptoms. The elimination rate of&#xD;
      intraepithelial neoplasia of gastric mucosa was expected to be improved by 9-12%. Moreover,&#xD;
      high quality evidence-based medical evidence regarding traditional Chinese medicine (TCM) in&#xD;
      intervening gastric Premalignant lesion would be obtained, which could form the mature,&#xD;
      propagable and effective scheme. At the same time, molecular and biological indicators,&#xD;
      including CDX2, SOX2, MUC2, MUC6, MUC5AC and CD10, were detected using the pathological&#xD;
      tissues, so as to explore the therapeutic mechanism of Jianpi Huoxue Recipe in intervening&#xD;
      gastric Premalignant lesion, and to construct the model platform for special disease research&#xD;
      on gastric Premalignant lesion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <phase>Phase 1/Phase 2</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>The disappearance rate of dysplasia</measure>
    <time_frame>six months</time_frame>
    <description>The all patients' histopathology will be evaluated two times, the first time is when the patients' are included into the clinical trials, the second time is after 24 weeks treatment in each group, patients' histopathology should be evaluated for comparison between two groups,at the same time patients' histopathology should be evaluated for comparison in each group.The change in histological score (mean score of all biopsie after treatment in each group and between groups was calculated. The response rate of each pathological lesion was calculated as a percentage of those improved or disappeared at the 6th month to all subjects. The disappearance rate of dysplasia between groups were compared, which was defined as the absence of dysplasia (score 0) in all biopsy specimens after treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The score changes of histopathology</measure>
    <time_frame>six months</time_frame>
    <description>The score changes of atrophy, intestinal metaplasia, chronic inflammation and active inflammation compared between baseline and after 6-month treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The score changes of Endoscopic Findings</measure>
    <time_frame>six months</time_frame>
    <description>The score changes of endoscopic findings, such as erosion, bleeding, coarse and uneven mucosa, and bile reflux were compared between baseline and after 6-month treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Main symptom score</measure>
    <time_frame>six months</time_frame>
    <description>Changes of symptom score were compared. The symptom include upper abdominal pain, upper abdominal distension, poor appetite, nausea and belching. The disappearance rate of symptom was expressed as a percentage of the subjects whose symptoms disappeared after medication to those exhibiting symptoms before medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The patient-reported outcome (PRO)scale integrals</measure>
    <time_frame>six months</time_frame>
    <description>The patient-reported outcome (PRO) instrument for chronic gastrointestinal diseases was a 35-item instrument, including 6 dimensions of regurgitation, dyspepsia, defecation, general condition, emotion and social function. All items graded into 5 levels and scored 0-4, except for decreased appetite, which is grouped into 4 levels and scored 0-3.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">480</enrollment>
  <condition>Gastric Precancerous Condition</condition>
  <arm_group>
    <arm_group_label>MoLuoDan and Sanchi powder group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experiment group: oral administration of Moluodan concentrated pills with warm water before meal for 8 pills each time for three times a day, + oral administration of Sanchi powder mixing with warm water before meal for 3g each time for twice a day, + oral administration of Folic Acid Tablet simulation half a hour after meal for 5 mg each time for 3 times a day. The medication period was 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Folic Acid Tablet group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group: oral administration of Moluodan simulation medicine with warm water before meal for 8 pills each time for three times a day, + oral administration of Sanchi powder simulation medicine mixing with warm water before meal for 3g each time for twice a day, + oral administration of folic acid tablets half a hour after meal for 5 mg each time for 3 times a day. The medication period was 24 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MoLuoDan</intervention_name>
    <description>oral administration of Moluodan concentrated pills with warm water before meal for 8 pills each time for three times a day</description>
    <arm_group_label>MoLuoDan and Sanchi powder group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sanchi powder</intervention_name>
    <description>oral administration of Sanchi powder mixing with warm water before meal for 3g each time for twice a day</description>
    <arm_group_label>MoLuoDan and Sanchi powder group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Folic Acid Tablet</intervention_name>
    <description>oral administration of folic acid tablets half an hour after meal for 5 mg each time for 3 times a day.</description>
    <arm_group_label>Folic Acid Tablet group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MoLuoDan simulation</intervention_name>
    <description>oral administration of Moluodan simulation medicine with warm water before meal for 8 pills each time for three times a day</description>
    <arm_group_label>Folic Acid Tablet group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sanchi powder simulation</intervention_name>
    <description>oral administration of Sanchi powder simulation medicine mixing with warm water before meal for 3g each time for twice a day</description>
    <arm_group_label>Folic Acid Tablet group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Folic Acid Tablet simulation</intervention_name>
    <description>oral administration of folic acid simulation tablets half a hour after meal for 5 mg each time for 3 times a day.</description>
    <arm_group_label>MoLuoDan and Sanchi powder group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Outpatients and inpatients diagnosed with chronic atrophic gastritis accompanying with&#xD;
             low grade intraepithelial neoplasia and indefinite dysphasia confirmed by gastroscopy&#xD;
             and histopathological examination;&#xD;
&#xD;
          2. Patients aged from 18-75 years;&#xD;
&#xD;
          3. Subjects who were informed and voluntarily signed the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients pathohistologically diagnosed with high grade intraepithelial&#xD;
             neoplasia/severe dysplasia;&#xD;
&#xD;
          2. Patients with a history of gastric ulcer, gastric polyps and gastric surgery;&#xD;
&#xD;
          3. Patients taking NSAIDs for a long term;&#xD;
&#xD;
          4. Patients suspected of gastric cancer or malignant lesions in other systems;&#xD;
&#xD;
          5. Patients with a history of gastric surgery;&#xD;
&#xD;
          6. Patients with concurrent primary diseases in cardiovascular, cerebrovascular, liver,&#xD;
             kidney and hemopoietic systems (ALT&gt;80 u/L, and/or AST&gt;80 u/L, with abnormal renal&#xD;
             function)&#xD;
&#xD;
          7. Patients with mental disease, dysgnosia and logopathy;&#xD;
&#xD;
          8. Pregnant women, or those preparing a pregnancy and breastfeeding women;&#xD;
&#xD;
          9. Patients with a allergic history of medicines used in this experiment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Xiangxue Ma, Doctor</last_name>
    <phone>+86(010)62835641</phone>
    <email>maxiangxue@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Xiyuan Hospital of China Academy of Chinese Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <zip>100091</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiangxue Ma</last_name>
      <email>maxiangxue@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>July 11, 2018</study_first_submitted>
  <study_first_submitted_qc>January 27, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>June 23, 2021</last_update_submitted>
  <last_update_submitted_qc>June 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 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>Precancerous Conditions</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Folic Acid</mesh_term>
    <mesh_term>Vitamin B Complex</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03823248
org study id: 2017YFC1700601
nct id: NCT03823248
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study had adopted the multi-center, randomized and controlled experiment design based on
      standardized mucosal biopsy and pathohistological operation, as well as therapeutic
      evaluation methodology. Meanwhile, patients diagnosed with chronic atrophic gastritis
      accompanying with low grade intraepithelial neoplasia and indefinite dysphasia (grade C2/C3
      of Vienna classification) confirmed by gastroscopic histopathology were enrolled as the
      objects of study, while folic acid was used as the control. The therapeutic effect and safety
      of Jianpi Huoxue Recipe (Moluodan + Sanchi powder) in intervening the gastric Premalignant
      lesion were evaluated from the points of view of pathology, gastroscopy and symptoms. The
      elimination rate of intraepithelial neoplasia of gastric mucosa was expected to be improved
      by 9-12%. Moreover, high quality evidence-based medical evidence regarding traditional
      Chinese medicine (TCM) in intervening gastric Premalignant lesion would be obtained, which
      could form the mature, propagable and effective scheme.
Intraepithelial neoplasia of gastric mucosa is a well-recognized gastric Premalignant lesion,
      which is the key of secondary prevention for gastric cancer. However, no universally
      acknowledged effective therapeutic scheme is available at present. Previously, the
      investigator's research group has carried out clinical trial study based on solving the key
      problems such as diagnostic criteria, mucosal biopsy consistency and therapeutic evaluation
      methodology, and has attained certain achievements. This study had adopted the multi-center,
      randomized and controlled experiment design based on standardized mucosal biopsy and
      pathohistological operation, as well as therapeutic evaluation methodology. Meanwhile,
      patients diagnosed with chronic atrophic gastritis accompanying with low grade
      intraepithelial neoplasia and indefinite dysphasia (grade C2/C3 of Vienna classification)
      confirmed by gastroscopic histopathology were enrolled as the objects of study, while folic
      acid was used as the control. The therapeutic effect and safety of Jianpi Huoxue Recipe
      (Moluodan + Sanchi powder) in intervening the gastric Premalignant lesion were evaluated from
      the points of view of pathology, gastroscopy and symptoms. The elimination rate of
      intraepithelial neoplasia of gastric mucosa was expected to be improved by 9-12%. Moreover,
      high quality evidence-based medical evidence regarding traditional Chinese medicine (TCM) in
      intervening gastric Premalignant lesion would be obtained, which could form the mature,
      propagable and effective scheme. At the same time, molecular and biological indicators,
      including CDX2, SOX2, MUC2, MUC6, MUC5AC and CD10, were detected using the pathological
      tissues, so as to explore the therapeutic mechanism of Jianpi Huoxue Recipe in intervening
      gastric Premalignant lesion, and to construct the model platform for special disease research
      on gastric Premalignant lesion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: The disappearance rate of dysplasia
time frame: six months
description: The all patients' histopathology will be evaluated two times, the first time is when the patients' are included into the clinical trials, the second time is after 24 weeks treatment in each group, patients' histopathology should be evaluated for comparison between two groups,at the same time patients' histopathology should be evaluated for comparison in each group.The change in histological score (mean score of all biopsie after treatment in each group and between groups was calculated. The response rate of each pathological lesion was calculated as a percentage of those improved or disappeared at the 6th month to all subjects. The disappearance rate of dysplasia between groups were compared, which was defined as the absence of dysplasia (score 0) in all biopsy specimens after treatment.
measure: The score changes of histopathology
time frame: six months
description: The score changes of atrophy, intestinal metaplasia, chronic inflammation and active inflammation compared between baseline and after 6-month treatment.
measure: The score changes of Endoscopic Findings
time frame: six months
description: The score changes of endoscopic findings, such as erosion, bleeding, coarse and uneven mucosa, and bile reflux were compared between baseline and after 6-month treatment.
measure: Main symptom score
time frame: six months
description: Changes of symptom score were compared. The symptom include upper abdominal pain, upper abdominal distension, poor appetite, nausea and belching. The disappearance rate of symptom was expressed as a percentage of the subjects whose symptoms disappeared after medication to those exhibiting symptoms before medication.
measure: The patient-reported outcome (PRO)scale integrals
time frame: six months
description: The patient-reported outcome (PRO) instrument for chronic gastrointestinal diseases was a 35-item instrument, including 6 dimensions of regurgitation, dyspepsia, defecation, general condition, emotion and social function. All items graded into 5 levels and scored 0-4, except for decreased appetite, which is grouped into 4 levels and scored 0-3.
arm group label: MoLuoDan and Sanchi powder group
arm group type: Experimental
description: Experiment group: oral administration of Moluodan concentrated pills with warm water before meal for 8 pills each time for three times a day, + oral administration of Sanchi powder mixing with warm water before meal for 3g each time for twice a day, + oral administration of Folic Acid Tablet simulation half a hour after meal for 5 mg each time for 3 times a day. The medication period was 24 weeks.
arm group label: Folic Acid Tablet group
arm group type: Active Comparator
description: Control group: oral administration of Moluodan simulation medicine with warm water before meal for 8 pills each time for three times a day, + oral administration of Sanchi powder simulation medicine mixing with warm water before meal for 3g each time for twice a day, + oral administration of folic acid tablets half a hour after meal for 5 mg each time for 3 times a day. The medication period was 24 weeks.
intervention type: Drug
intervention name: MoLuoDan
description: oral administration of Moluodan concentrated pills with warm water before meal for 8 pills each time for three times a day
arm group label: MoLuoDan and Sanchi powder group
intervention type: Drug
intervention name: Sanchi powder
description: oral administration of Sanchi powder mixing with warm water before meal for 3g each time for twice a day
arm group label: MoLuoDan and Sanchi powder group
intervention type: Drug
intervention name: Folic Acid Tablet
description: oral administration of folic acid tablets half an hour after meal for 5 mg each time for 3 times a day.
arm group label: Folic Acid Tablet group
intervention type: Drug
intervention name: MoLuoDan simulation
description: oral administration of Moluodan simulation medicine with warm water before meal for 8 pills each time for three times a day
arm group label: Folic Acid Tablet group
intervention type: Drug
intervention name: Sanchi powder simulation
description: oral administration of Sanchi powder simulation medicine mixing with warm water before meal for 3g each time for twice a day
arm group label: Folic Acid Tablet group
intervention type: Drug
intervention name: Folic Acid Tablet simulation
description: oral administration of folic acid simulation tablets half a hour after meal for 5 mg each time for 3 times a day.
arm group label: MoLuoDan and Sanchi powder group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Xiangxue Ma, Doctor
phone: +86(010)62835641
email: maxiangxue@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Precancerous Conditions
mesh term: Folic Acid
mesh term: Vitamin B Complex
sharing ipd: No