<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/NCT03814629</url>
  </required_header>
  <id_info>
    <org_study_id>42507214-9</org_study_id>
    <nct_id>NCT03814629</nct_id>
  </id_info>
  <brief_title>Clinical Study of Weifuchun Treatment on Precancerous Lesions of Gastric Cancer</brief_title>
  <official_title>Randomized Clinical Trial: Weifuchun Treatment on Precancerous Lesions of Gastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ShuGuang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ShuGuang Hospital</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>
      Research purpose To elucidate the effect mechanism and clinical effective of weifuchun in the&#xD;
      prevention and treatment of chronic atrophic gastritis and precancerous lesions of gastric&#xD;
      cancer. From genes related to cell differentiation, proliferation, apoptosis, tumor invasion&#xD;
      and metastasis, genes related to immune inflammation and immune escape and other possible&#xD;
      aspects to elucidate the effective and mechanism of weifuchun's treatment on chronic atrophic&#xD;
      gastritis, reversing precancerous lesions of gastric cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Clinical research abstract Title of Research Study：Randomized clinical trial: Weifuchun&#xD;
      Treatment and mechanism on Precancerous Lesions of Gastric Cancer.&#xD;
&#xD;
      Main Responsibility Person: Mingyu Sun research center：Shuguang Hospital Affiliated to&#xD;
      Shanghai University of Traditional Chinese Medicine Trial Objective：Observe the clinical&#xD;
      efficacy and mechanism of Weifuchun in the treatment of chronic atrophic gastritis (CAG) and&#xD;
      precancerous lesions of gastric cancer (PLGC) Therapeutic Schedule：Select 60 cases of chronic&#xD;
      atrophic gastritis with intestinal metaplasia or dysplasia from and 60 cases of chronic&#xD;
      atrophic gastritis without intestinal metaplasia or dysplasia at the Shuguang Hospital&#xD;
      Affiliated to Shanghai University of Traditional Chinese Medicine. The treatment group was&#xD;
      given Weifuchun tablets, 4 tablets each time, 3 times a day, and 1 hour after meals. The&#xD;
      control group was given vitamin tablets (0.2 g), 4 tablets each time, 3 times a day, and 1&#xD;
      hour after a meal. The course of chronic atrophic gastritis with intestinal metaplasia or&#xD;
      dysplasia group treatment is 24 weeks, the course of chronic atrophic gastritis without&#xD;
      intestinal metaplasia or dysplasia is 12 weeks. The all patients'clinical symptoms,&#xD;
      histopathology, gastroscopy, and physical and chemical examinations were compared between the&#xD;
      two groups before and after treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 1, 2015</start_date>
  <completion_date type="Anticipated">September 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2019</primary_completion_date>
  <phase>Early Phase 1</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>histopathology is assessing a change</measure>
    <time_frame>the patients' were included into the clinical trials and after 24 weeks treatment.</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.We use Total score of gastric mucosa pathology to assess the therapeutic effect,the patients' were included into the clinical trials and after 24 weeks treatment we through the Pathological classification of chronic atrophic gastritis work out Total score of gastric mucosa pathology.&#xD;
As follows:&#xD;
There are five pathology grade:Chronic inflammation,Active,Atrophy,intestinal metaplasia,dysplasia.&#xD;
Score 0 is normal;1 is mild; 2 is moderate;3 is severe;cumulative highest score is 15, cumulative lowest score is 0.The higher summed score, the more severe the pathological changes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>gastroscopy is assessing a change</measure>
    <time_frame>the patients' were included into the clinical trials and after 24 weeks treatment.</time_frame>
    <description>The all patients' gastroscopy gastric mucosa manifestations evaluation 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' gastroscopy gastric mucosa manifestations should be evaluated for comparison between two groups, at the same time patients' gastroscopy should be evaluated for comparison in each group.&#xD;
We use Gastric mucosa classification under gastroscope of chronic atrophic gastritis to assess the therapeutic effect,work out gastroscopy gastric mucosa manifestations integral.&#xD;
There are four Gastric mucosa classification under gastroscope of chronic atrophic gastritis: erythema,erosion,Intramucosal hemorrhage,bile regurgitation.Score 0 is normal;1 is mild; 2 is moderate;3 is severe;cumulative highest score is 12, cumulative lowest score is 0.The higher summed score, the more severe the pathological changes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical symptom score is assessing a change</measure>
    <time_frame>the patients' were included into the clinical trials and after 24 weeks treatment.</time_frame>
    <description>The all patients Clinical symptom assessment score when the patients' were included into the clinical trials and after 24 weeks treatment in each group. We use Clinical Symptom checklist to assess the therapeutic effect,work out Clinical Symptom integral. Clinical symptom mainly includes stomachache, acid reflux, burping, easy to hungry. Score 0 is frequency never;1 is occasionally; 2 is sometimes;3 is often; 4 is always. Summed highest score is 16, summed lowest score is 0.The higher summed score, the more severe the Clinical symptom.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>blood routine examination</measure>
    <time_frame>the patients' were included into the clinical trials and after 24 weeks treatment</time_frame>
    <description>The all patients ' blood routine examination(WBC,Hb,PLT) evaluation when the patients' were included into the clinical trials and after 24 weeks treatment in each group, this is for Clinical trial safety assessment.To assess the rate of abnormal blood routine examination(WBC,Hb,PLT) in each group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>liver function test</measure>
    <time_frame>the patients' were included into the clinical trials and after 24 weeks treatment</time_frame>
    <description>The all patients ' liver function test(ALT,Aspartate aminotransferase ,ALP) evaluation when the patients' were included into the clinical trials and after 24 weeks treatment in each group, this is for Clinical trial safety assessment.To assess the rate of abnormal liver function test(ALT,Aspartate aminotransferase ,ALP) in each group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>kidney function test</measure>
    <time_frame>the patients' were included into the clinical trials and after 24 weeks treatment</time_frame>
    <description>The all patients ' kidney function test(Cr,BUN) evaluation when the patients' were included into the clinical trials and after 24 weeks treatment in each group, this is for Clinical trial safety assessment.To assess the rate of abnormal kidney function test(Cr,BUN) in each group.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Chronic Atrophic Gastritis With Hyperplasia (Diagnosis)</condition>
  <arm_group>
    <arm_group_label>precancerous lesions of gastric cancer</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>120 cases of chronic atrophic gastritis with intestinal metaplasia or dysplasia,It was randomly divided into 60 cases of treatment group and 60 cases of control group,treatment group was given Weifuchun tablets,The control group was given vitamin tablets.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Weifuchun</intervention_name>
    <description>The treatment group（Weifuchun group）was given Weifuchun tablets, 4 tablets each time, 3 times a day, and 1 hour after meals. The control group(vitamin group) was given vitamin tablets (0.2 g), 4 tablets each time, 3 times a day, and 1 hour after a meal.</description>
    <arm_group_label>precancerous lesions of gastric cancer</arm_group_label>
    <other_name>vitamin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with chronic atrophic gastritis and precancerous lesions according to the&#xD;
             pathological findings under gastroscope&#xD;
&#xD;
          2. Helicobacter pylori(-)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with Helicobacter pylori positive infection without radical treatment.&#xD;
&#xD;
          2. Patients with peptic ulcer, severe dysplasia or suspected malignant transformation.&#xD;
&#xD;
          3. Pregnant or lactating women and those who are pregnant and may not have effective&#xD;
             contraception.&#xD;
&#xD;
          4. Patients with severe heart, lung, gallbladder, kidney, endocrine, hematopoietic system&#xD;
             and neuropsychiatric diseases should not be included in this study.&#xD;
&#xD;
          5. Allergic constitution or known ingredients of this medicine.&#xD;
&#xD;
          6. Patients with other tumors.&#xD;
&#xD;
          7. Patients participating in other clinical trials within 1 month.&#xD;
&#xD;
          8. Patients with severe cirrhotic ascites and portal hypertension.&#xD;
&#xD;
          9. Other diseases that interfered with the study were deemed unsuitable for the patients&#xD;
             included in the study.&#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_official>
    <last_name>Mingyu Sun, doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine</affiliation>
  </overall_official>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 30, 2018</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>January 18, 2019</last_update_submitted>
  <last_update_submitted_qc>January 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>ShuGuang Hospital</investigator_affiliation>
    <investigator_full_name>Mingyu Sun</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>chronic atrophic gastritis</keyword>
  <keyword>precancerous lesions of gastric cancer</keyword>
  <keyword>Weifuchun</keyword>
  <keyword>randomized clinical trial</keyword>
  <keyword>mechanism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
    <mesh_term>Gastritis</mesh_term>
    <mesh_term>Gastritis, Atrophic</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
    <mesh_term>Atrophy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamins</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03814629
org study id: 42507214-9
nct id: NCT03814629
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Research purpose To elucidate the effect mechanism and clinical effective of weifuchun in the
      prevention and treatment of chronic atrophic gastritis and precancerous lesions of gastric
      cancer. From genes related to cell differentiation, proliferation, apoptosis, tumor invasion
      and metastasis, genes related to immune inflammation and immune escape and other possible
      aspects to elucidate the effective and mechanism of weifuchun's treatment on chronic atrophic
      gastritis, reversing precancerous lesions of gastric cancer.
Clinical research abstract Title of Research Study：Randomized clinical trial: Weifuchun
      Treatment and mechanism on Precancerous Lesions of Gastric Cancer.

      Main Responsibility Person: Mingyu Sun research center：Shuguang Hospital Affiliated to
      Shanghai University of Traditional Chinese Medicine Trial Objective：Observe the clinical
      efficacy and mechanism of Weifuchun in the treatment of chronic atrophic gastritis (CAG) and
      precancerous lesions of gastric cancer (PLGC) Therapeutic Schedule：Select 60 cases of chronic
      atrophic gastritis with intestinal metaplasia or dysplasia from and 60 cases of chronic
      atrophic gastritis without intestinal metaplasia or dysplasia at the Shuguang Hospital
      Affiliated to Shanghai University of Traditional Chinese Medicine. The treatment group was
      given Weifuchun tablets, 4 tablets each time, 3 times a day, and 1 hour after meals. The
      control group was given vitamin tablets (0.2 g), 4 tablets each time, 3 times a day, and 1
      hour after a meal. The course of chronic atrophic gastritis with intestinal metaplasia or
      dysplasia group treatment is 24 weeks, the course of chronic atrophic gastritis without
      intestinal metaplasia or dysplasia is 12 weeks. The all patients'clinical symptoms,
      histopathology, gastroscopy, and physical and chemical examinations were compared between the
      two groups before and after treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: histopathology is assessing a change
time frame: the patients' were included into the clinical trials and after 24 weeks treatment.
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.We use Total score of gastric mucosa pathology to assess the therapeutic effect,the patients' were included into the clinical trials and after 24 weeks treatment we through the Pathological classification of chronic atrophic gastritis work out Total score of gastric mucosa pathology.
As follows:
There are five pathology grade:Chronic inflammation,Active,Atrophy,intestinal metaplasia,dysplasia.
Score 0 is normal;1 is mild; 2 is moderate;3 is severe;cumulative highest score is 15, cumulative lowest score is 0.The higher summed score, the more severe the pathological changes.
measure: gastroscopy is assessing a change
time frame: the patients' were included into the clinical trials and after 24 weeks treatment.
description: The all patients' gastroscopy gastric mucosa manifestations evaluation 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' gastroscopy gastric mucosa manifestations should be evaluated for comparison between two groups, at the same time patients' gastroscopy should be evaluated for comparison in each group.
We use Gastric mucosa classification under gastroscope of chronic atrophic gastritis to assess the therapeutic effect,work out gastroscopy gastric mucosa manifestations integral.
There are four Gastric mucosa classification under gastroscope of chronic atrophic gastritis: erythema,erosion,Intramucosal hemorrhage,bile regurgitation.Score 0 is normal;1 is mild; 2 is moderate;3 is severe;cumulative highest score is 12, cumulative lowest score is 0.The higher summed score, the more severe the pathological changes.
measure: Clinical symptom score is assessing a change
time frame: the patients' were included into the clinical trials and after 24 weeks treatment.
description: The all patients Clinical symptom assessment score when the patients' were included into the clinical trials and after 24 weeks treatment in each group. We use Clinical Symptom checklist to assess the therapeutic effect,work out Clinical Symptom integral. Clinical symptom mainly includes stomachache, acid reflux, burping, easy to hungry. Score 0 is frequency never;1 is occasionally; 2 is sometimes;3 is often; 4 is always. Summed highest score is 16, summed lowest score is 0.The higher summed score, the more severe the Clinical symptom.
measure: blood routine examination
time frame: the patients' were included into the clinical trials and after 24 weeks treatment
description: The all patients ' blood routine examination(WBC,Hb,PLT) evaluation when the patients' were included into the clinical trials and after 24 weeks treatment in each group, this is for Clinical trial safety assessment.To assess the rate of abnormal blood routine examination(WBC,Hb,PLT) in each group.
measure: liver function test
time frame: the patients' were included into the clinical trials and after 24 weeks treatment
description: The all patients ' liver function test(ALT,Aspartate aminotransferase ,ALP) evaluation when the patients' were included into the clinical trials and after 24 weeks treatment in each group, this is for Clinical trial safety assessment.To assess the rate of abnormal liver function test(ALT,Aspartate aminotransferase ,ALP) in each group.
measure: kidney function test
time frame: the patients' were included into the clinical trials and after 24 weeks treatment
description: The all patients ' kidney function test(Cr,BUN) evaluation when the patients' were included into the clinical trials and after 24 weeks treatment in each group, this is for Clinical trial safety assessment.To assess the rate of abnormal kidney function test(Cr,BUN) in each group.
arm group label: precancerous lesions of gastric cancer
arm group type: Other
description: 120 cases of chronic atrophic gastritis with intestinal metaplasia or dysplasia,It was randomly divided into 60 cases of treatment group and 60 cases of control group,treatment group was given Weifuchun tablets,The control group was given vitamin tablets.
intervention type: Drug
intervention name: Weifuchun
description: The treatment group（Weifuchun group）was given Weifuchun tablets, 4 tablets each time, 3 times a day, and 1 hour after meals. The control group(vitamin group) was given vitamin tablets (0.2 g), 4 tablets each time, 3 times a day, and 1 hour after a meal.
arm group label: precancerous lesions of gastric cancer
other name: vitamin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mingyu Sun, doctor
role: Principal Investigator
affiliation: Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
responsible party type: Principal Investigator
investigator affiliation: ShuGuang Hospital
investigator full name: Mingyu Sun
investigator title: Clinical Professor
mesh term: Stomach Neoplasms
mesh term: Gastritis
mesh term: Gastritis, Atrophic
mesh term: Hyperplasia
mesh term: Atrophy
mesh term: Vitamins
sharing ipd: Undecided