<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/NCT04484870</url>
  </required_header>
  <id_info>
    <org_study_id>（109）-1</org_study_id>
    <nct_id>NCT04484870</nct_id>
  </id_info>
  <brief_title>Danshu Capsule and Ursodeoxycholic Acid Capsule in Preventing Recurrence of Choledocholithiasis</brief_title>
  <official_title>Comparative Study on the Efficacy of Danshu Capsule and Ursodeoxycholic Acid Capsule in Preventing Recurrence of Choledocholithiasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First People's Hospital of Hangzhou</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First People's Hospital of Hangzhou</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>
      [objective] to compare the efficacy of Danshu capsule and ursodeoxycholic acid (UDCA) in&#xD;
      preventing recurrence of choledocholithiasis after operation. [methods] one hundred and fifty&#xD;
      ERCP patients with choledocholithiasis were randomly divided into two groups: Danshu group (n&#xD;
      = 75) and UDCA group (n = 75). The Danshu group took 2 Danshu capsules three times a day, and&#xD;
      the UDCA group took 250 mg of Ursofalk twice a day. The clinical efficacy, changes of liver&#xD;
      function indexes before and after treatment and stone recurrence were compared between the&#xD;
      two groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">July 20, 2019</completion_date>
  <primary_completion_date type="Actual">July 30, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>recurrence rate</measure>
    <time_frame>1 year</time_frame>
    <description>abdominal ultrasound or MRCP/CT was used to examine every 3 months after operation for 1 year, and the recurrence was recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>improvement rate of liver function index</measure>
    <time_frame>3 days, 1 week and 2 weeks</time_frame>
    <description>5ml of fasting elbow venous blood was taken before treatment and 3 days, 1 week and 2 weeks after treatment respectively. The blood samples were centrifuged and the supernatant was taken. Total bilirubin (total bilirubin, TBil), glutamic pyruvic transaminase (Alanine aminotransferase, ALT), glutamic oxaloacetic transaminase (Aspartate aminotransferase, AST) and γ-glutamyl transpeptidase (γ-glutamyl transpeptidase, GGT)) in blood samples were detected by automatic biochemical analyzer.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Choledocholithiasis</condition>
  <condition>Recurrence</condition>
  <arm_group>
    <arm_group_label>Danshu capsule group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients in Danshu group were treated with Danshu capsule, 2 tablets per time, 3 times a day (0.45g/ tablets)，The course of treatment was 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ursodeoxycholic acid group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>UDCA group, 250mg/ was taken orally twice a day (0.25g/, Losan Pharma GmbH company). The course of treatment was 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oral Danshu capsule</intervention_name>
    <description>Danshu group oral Danshu capsule, 2 tablets per time, 3 times a day (0.45g/ tablets, Sichuan Jishengtang Pharmaceutical Co., Ltd.)</description>
    <arm_group_label>Danshu capsule group</arm_group_label>
    <arm_group_label>ursodeoxycholic acid group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        inclusion criteria:&#xD;
&#xD;
          1. Choledocholithiasis was diagnosed by B-ultrasound / CT/MRCP, The patients are&#xD;
             generally in good condition, no surgical taboos, and can tolerate general anesthesia&#xD;
             and ERCP surgery.&#xD;
&#xD;
          2. Agree to participate in the project research, know the benefits and possible risks of&#xD;
             surgery, know the benefits and risks of drugs, and sign an informed consent form.&#xD;
&#xD;
        exclusion criteria：&#xD;
&#xD;
          1. patients with cholecystolithiasis, hepatitis B, biliary ascariasis, liver cirrhosis,&#xD;
             hemolytic anemia, congenital jaundice and tumor were excluded.&#xD;
&#xD;
          2. Excluding serious primary diseases such as heart, brain, lung, kidney and blood&#xD;
             system.&#xD;
&#xD;
          3. Those who are allergic or allergic to drugs in this test are excluded.&#xD;
&#xD;
          4. Pregnancy vibration or nursing women were excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaofeng Zhang, Zhang</last_name>
    <role>Study Director</role>
    <affiliation>First People's Hospital of Hangzhou</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hangzhou first people's Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First People's Hospital of Hangzhou</investigator_affiliation>
    <investigator_full_name>ZhangXiaofeng</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>Choledocholithiasis</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_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/NCT04484870
org study id: （109）-1
nct id: NCT04484870
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
[objective] to compare the efficacy of Danshu capsule and ursodeoxycholic acid (UDCA) in
      preventing recurrence of choledocholithiasis after operation. [methods] one hundred and fifty
      ERCP patients with choledocholithiasis were randomly divided into two groups: Danshu group (n
      = 75) and UDCA group (n = 75). The Danshu group took 2 Danshu capsules three times a day, and
      the UDCA group took 250 mg of Ursofalk twice a day. The clinical efficacy, changes of liver
      function indexes before and after treatment and stone recurrence were compared between the
      two groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: recurrence rate
time frame: 1 year
description: abdominal ultrasound or MRCP/CT was used to examine every 3 months after operation for 1 year, and the recurrence was recorded.
measure: improvement rate of liver function index
time frame: 3 days, 1 week and 2 weeks
description: 5ml of fasting elbow venous blood was taken before treatment and 3 days, 1 week and 2 weeks after treatment respectively. The blood samples were centrifuged and the supernatant was taken. Total bilirubin (total bilirubin, TBil), glutamic pyruvic transaminase (Alanine aminotransferase, ALT), glutamic oxaloacetic transaminase (Aspartate aminotransferase, AST) and γ-glutamyl transpeptidase (γ-glutamyl transpeptidase, GGT)) in blood samples were detected by automatic biochemical analyzer.
arm group label: Danshu capsule group
arm group type: Experimental
description: The patients in Danshu group were treated with Danshu capsule, 2 tablets per time, 3 times a day (0.45g/ tablets)，The course of treatment was 6 months
arm group label: ursodeoxycholic acid group
arm group type: Active Comparator
description: UDCA group, 250mg/ was taken orally twice a day (0.25g/, Losan Pharma GmbH company). The course of treatment was 6 months
intervention type: Drug
intervention name: oral Danshu capsule
description: Danshu group oral Danshu capsule, 2 tablets per time, 3 times a day (0.45g/ tablets, Sichuan Jishengtang Pharmaceutical Co., Ltd.)
arm group label: Danshu capsule group
arm group label: ursodeoxycholic acid group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xiaofeng Zhang, Zhang
role: Study Director
affiliation: First People's Hospital of Hangzhou
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: First People's Hospital of Hangzhou
investigator full name: ZhangXiaofeng
investigator title: Director of Department of Gastroenterology
mesh term: Choledocholithiasis
mesh term: Recurrence
sharing ipd: No