<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/NCT02226185</url>
  </required_header>
  <id_info>
    <org_study_id>RJ2014BH</org_study_id>
    <nct_id>NCT02226185</nct_id>
  </id_info>
  <brief_title>Study of Berberine Hydrochloride in Prevention of Colorectal Adenomas Recurrence</brief_title>
  <official_title>A Randomized, Placebo-controlled, Multicenter, Prospective Clinical Study of Berberine Hydrochloride in Preventing Recurrence and Carcinogenesis After Endoscopic Removal of Colorectal Adenomas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Jiao Tong University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Berberine hydrochloride is a conventional component in Chinese medicine. In recent years,&#xD;
      anticancer activity of berberine hydrochloride have been explored. The aim of this study is&#xD;
      to investigate the effect of berberine hydrochloride on the recurrence of colorectal&#xD;
      adenomas.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Colorectal adenomas are well-known to be precancerous lesions that develop into colorectal&#xD;
      cancers on the basis of the adenoma-carcinoma sequence. The effects of screening for&#xD;
      colorectal adenomas and removing precancerous lesions on the prevention of colorectal cancer&#xD;
      have been established. Because of the high recurrence rates of colorectal adenomas in&#xD;
      patients who have undergone polypectomy, the potential chemopreventive agents that may reduce&#xD;
      the risk of colorectal adenoma recurrence need to be investigated.&#xD;
&#xD;
      Berberine hydrochloride is a conventional component in Chinese medicine. In recent years,&#xD;
      anticancer activity of berberine hydrochloride have been explored. The aim of this study is&#xD;
      to investigate the effect of berberine hydrochloride on the recurrence of colorectal adenomas&#xD;
      by conducting a randomized, placebo-controlled, prospective clinical.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Actual">December 29, 2018</completion_date>
  <primary_completion_date type="Actual">December 29, 2018</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrence rates of CRA</measure>
    <time_frame>until the last patient reached the 2 years follow-up</time_frame>
    <description>The primary objective of this study is to investigate recurrence rates of colorectal adenoma (CRA) after Berberine hydrochloride or placebo intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidence of all polypoid lesions or advanced colorectal adenoma or colorectal cancer</measure>
    <time_frame>until the last patient reached the 2 years follow-up</time_frame>
    <description>The incidence of all polypoid lesions or advanced colorectal adenoma or colorectal cancer after Berberine hydrochloride or placebo intervention</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in fecal microflora</measure>
    <time_frame>baseline, the 1st year and the 2nd year</time_frame>
    <description>Fecal microflora tests</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1108</enrollment>
  <condition>Colorectal Adenoma</condition>
  <arm_group>
    <arm_group_label>Berberine hydrochloride</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>identical-appearing placebo supplements for 2-3 years</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Berberine hydrochloride</intervention_name>
    <description>supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years</description>
    <arm_group_label>Berberine hydrochloride</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>supplement of placebo two times per day for 2-3 years</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Individuals aged 18-75 years&#xD;
&#xD;
          -  Individuals who had at least one and no more than 6 histologically confirmed CRAs&#xD;
             removed within 6 months before recruitment&#xD;
&#xD;
          -  Individuals who are able to swallow pills&#xD;
&#xD;
          -  Individuals who voluntarily sign the consent form after being fully informed and&#xD;
             understanding the purpose and procedure of this study, characters of the disease,&#xD;
             effect of medication, methods of related examinations, and potential risk/benefits of&#xD;
             the study 4.2 Exclusion criteria&#xD;
&#xD;
          -  Individuals whose adenoma was not completely removed during previous colonoscopy&#xD;
&#xD;
          -  Individuals with a history of familial adenomatous polyposis (FAP) or hereditary&#xD;
             non-polyposis colorectal cancer (HNPCC, Lynch syndrome)&#xD;
&#xD;
          -  Individuals who are taking regularly aspirin, nonsteroidal anti-inflammatory drugs&#xD;
             (NSAIDs), cyclo-oxygenase 2 (COX2) inhibitors, calcium or vitamin D&#xD;
&#xD;
          -  Individuals with a history of subtotal/total gastrectomy or partial bowel resection&#xD;
&#xD;
          -  Individuals who are intolerant to another colonoscopy examination&#xD;
&#xD;
          -  Individuals who are hypersensitive or intolerant to the drugs&#xD;
&#xD;
          -  Individuals with severe heart, liver or kidney disease, or any cancer history&#xD;
&#xD;
          -  Individuals presenting severe constipation&#xD;
&#xD;
          -  Pregnant women, women during breast-feeding period, or women with expect pregnancy&#xD;
&#xD;
          -  Individuals with mental diseases who are not able to cooperate&#xD;
&#xD;
          -  Individuals who are involved in designing, planning or performing this trial&#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_official>
    <last_name>Jing-Yuan Fang, M.D., Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Jiao Tong University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Gastroenterology, the Seventh Medical Center of PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Gastroenterology, Zhongshan Hospital, Xiamen University</name>
      <address>
        <city>Xiamen</city>
        <state>Fujian</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Gastroenterology, Nanfang Hospital, Southern Medical Univerisity</name>
      <address>
        <city>Guangdong</city>
        <state>Guangzhou</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Division of Gastroenterology and Hepatology, The Affiliated DrumTower of Nanjing University Medical School</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Division of Gastroenterology and Hepatology, Ren-Ji Hospital, Shanghai Jiao-Tong University School of Medicine, Shanghai Institute of Digestive Disease; Key Laboratory of Gastroenterology &amp; Hepatology, Ministry of Health</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Gastroenterology, the Shanghai Tenth People's Hospital, Tongji University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 23, 2014</study_first_submitted>
  <study_first_submitted_qc>August 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>March 21, 2019</last_update_submitted>
  <last_update_submitted_qc>March 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
    <investigator_full_name>Jing-yuan Fang, MD, Ph. D</investigator_full_name>
    <investigator_title>Director of Department of Gastroenterology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 22, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/85/NCT02226185/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>November 12, 2020</submitted>
    <returned>December 8, 2020</returned>
  </pending_results>
  <!-- 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/NCT02226185
org study id: RJ2014BH
nct id: NCT02226185
lead sponsor: 
has dmc: Yes
Berberine hydrochloride is a conventional component in Chinese medicine. In recent years,
      anticancer activity of berberine hydrochloride have been explored. The aim of this study is
      to investigate the effect of berberine hydrochloride on the recurrence of colorectal
      adenomas.
Colorectal adenomas are well-known to be precancerous lesions that develop into colorectal
      cancers on the basis of the adenoma-carcinoma sequence. The effects of screening for
      colorectal adenomas and removing precancerous lesions on the prevention of colorectal cancer
      have been established. Because of the high recurrence rates of colorectal adenomas in
      patients who have undergone polypectomy, the potential chemopreventive agents that may reduce
      the risk of colorectal adenoma recurrence need to be investigated.

      Berberine hydrochloride is a conventional component in Chinese medicine. In recent years,
      anticancer activity of berberine hydrochloride have been explored. The aim of this study is
      to investigate the effect of berberine hydrochloride on the recurrence of colorectal adenomas
      by conducting a randomized, placebo-controlled, prospective clinical.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Recurrence rates of CRA
time frame: until the last patient reached the 2 years follow-up
description: The primary objective of this study is to investigate recurrence rates of colorectal adenoma (CRA) after Berberine hydrochloride or placebo intervention.
measure: The incidence of all polypoid lesions or advanced colorectal adenoma or colorectal cancer
time frame: until the last patient reached the 2 years follow-up
description: The incidence of all polypoid lesions or advanced colorectal adenoma or colorectal cancer after Berberine hydrochloride or placebo intervention
measure: Changes in fecal microflora
time frame: baseline, the 1st year and the 2nd year
description: Fecal microflora tests
arm group label: Berberine hydrochloride
arm group type: Experimental
description: supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years
arm group label: placebo
arm group type: Placebo Comparator
description: identical-appearing placebo supplements for 2-3 years
intervention type: Drug
intervention name: Berberine hydrochloride
description: supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years
arm group label: Berberine hydrochloride
intervention type: Drug
intervention name: placebo
description: supplement of placebo two times per day for 2-3 years
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jing-Yuan Fang, M.D., Ph.D
role: Principal Investigator
affiliation: Shanghai Jiao Tong University School of Medicine
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Jiao Tong University School of Medicine
investigator full name: Jing-yuan Fang, MD, Ph. D
investigator title: Director of Department of Gastroenterology
mesh term: Adenoma
mesh term: Recurrence
provided document: 
submitted: November 12, 2020
returned: December 8, 2020