<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/NCT02204189</url>
  </required_header>
  <id_info>
    <org_study_id>z141100002114004</org_study_id>
    <nct_id>NCT02204189</nct_id>
  </id_info>
  <brief_title>The Clinical Study of Acute Pancreatitis Treated by TongFuSan</brief_title>
  <official_title>The Clinical Study of Acute Pancreatitis With Gastrointestinal Dysfunction Treated by TongFuSan for External Application on ShenQue Acupoint</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Friendship Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether TongFuSan is effective in the treatment of&#xD;
      acute pancreatitis with gastrointestinal dysfunction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Patient who is diagnosed with acute pancreatitis(AP) should be included.&#xD;
&#xD;
        -  Patients will be divided into two groups as random number table: control group(A) and&#xD;
           experimental group(B).&#xD;
&#xD;
        -  Group A will be given Mosapride po,and group B will be given TongFusan except for basic&#xD;
           treatments of AP.&#xD;
&#xD;
        -  Same investigator will write the case report form.&#xD;
&#xD;
        -  Investigator will collect the patients' blood in three points: on admission, the third&#xD;
           day and the seventh day.&#xD;
&#xD;
        -  Otherwise, we need write down patients' clinical manifestation,Traditional Chinese&#xD;
           Medicine differentiation, the result of clinical tests.&#xD;
&#xD;
        -  When the patient discharge, we will write down the treatment measures, therapeutic&#xD;
           effect, length of stay and the costs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2014</start_date>
  <completion_date type="Anticipated">February 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2014</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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the time of first defecation</measure>
    <time_frame>ten days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>the time of bowel sounds getting back to normal</measure>
    <time_frame>ten days</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Hospitalization cost</measure>
    <time_frame>ten days</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Acute Pancreatitis</condition>
  <arm_group>
    <arm_group_label>TongFuSan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TongFuSan 1g per time, change every day, the duration is seven days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TongFuSan</intervention_name>
    <description>TongFuSan 1g</description>
    <arm_group_label>TongFuSan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical diagnosis of acute pancreatitis，both mild type and severe type&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant or suckling&#xD;
&#xD;
          -  cancer in late time&#xD;
&#xD;
          -  patient near death&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bin Miao, PHD</last_name>
    <role>Study Chair</role>
    <affiliation>Beijing Friendship Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hong Wang, Graduate</last_name>
    <role>Study Director</role>
    <affiliation>Beijing Friendship Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shuwen Zhang, bachelor</last_name>
    <role>Study Director</role>
    <affiliation>Beijing Friendship Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chao Wang, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Friendship Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yanli Su, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Friendship Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shirong Li, graduate</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Friendship Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fengwu Li, graduate</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Friendship Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dinghua Xu, graduate</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Friendship Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hong You, PHD</last_name>
    <phone>010-63139197</phone>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Bin Miao, PHD</last_name>
    <phone>18612252085</phone>
    <email>miaobin0105@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beijing Friendship Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100054</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hong You, PHD</last_name>
      <phone>010-63139197</phone>
    </contact>
    <contact_backup>
      <last_name>Wanzhen Xu, PHD</last_name>
      <phone>010-63138049</phone>
    </contact_backup>
    <investigator>
      <last_name>Fengwu Li, graduate</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>July 29, 2014</last_update_submitted>
  <last_update_submitted_qc>July 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Friendship Hospital</investigator_affiliation>
    <investigator_full_name>miaobin</investigator_full_name>
    <investigator_title>associate chief physician</investigator_title>
  </responsible_party>
  <keyword>acute pancreatitis</keyword>
  <keyword>gastrointestinal dysfunction</keyword>
  <keyword>TongFuSan</keyword>
  <keyword>ShenQue acupoint</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</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/NCT02204189
org study id: z141100002114004
nct id: NCT02204189
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether TongFuSan is effective in the treatment of
      acute pancreatitis with gastrointestinal dysfunction.
-  Patient who is diagnosed with acute pancreatitis(AP) should be included.

        -  Patients will be divided into two groups as random number table: control group(A) and
           experimental group(B).

        -  Group A will be given Mosapride po,and group B will be given TongFusan except for basic
           treatments of AP.

        -  Same investigator will write the case report form.

        -  Investigator will collect the patients' blood in three points: on admission, the third
           day and the seventh day.

        -  Otherwise, we need write down patients' clinical manifestation,Traditional Chinese
           Medicine differentiation, the result of clinical tests.

        -  When the patient discharge, we will write down the treatment measures, therapeutic
           effect, length of stay and the costs.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: the time of first defecation
time frame: ten days
measure: the time of bowel sounds getting back to normal
time frame: ten days
measure: Hospitalization cost
time frame: ten days
arm group label: TongFuSan
arm group type: Experimental
description: TongFuSan 1g per time, change every day, the duration is seven days
intervention type: Drug
intervention name: TongFuSan
description: TongFuSan 1g
arm group label: TongFuSan
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bin Miao, PHD
role: Study Chair
affiliation: Beijing Friendship Hospital
last name: Hong Wang, Graduate
role: Study Director
affiliation: Beijing Friendship Hospital
last name: Shuwen Zhang, bachelor
role: Study Director
affiliation: Beijing Friendship Hospital
last name: Chao Wang, PHD
role: Principal Investigator
affiliation: Beijing Friendship Hospital
last name: Yanli Su, PHD
role: Principal Investigator
affiliation: Beijing Friendship Hospital
last name: Shirong Li, graduate
role: Principal Investigator
affiliation: Beijing Friendship Hospital
last name: Fengwu Li, graduate
role: Principal Investigator
affiliation: Beijing Friendship Hospital
last name: Dinghua Xu, graduate
role: Principal Investigator
affiliation: Beijing Friendship Hospital
last name: Hong You, PHD
phone: 010-63139197
last name: Bin Miao, PHD
phone: 18612252085
email: miaobin0105@126.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Friendship Hospital
investigator full name: miaobin
investigator title: associate chief physician
mesh term: Pancreatitis