<clinical_study>
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    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/NCT02239237</url>
  </required_header>
  <id_info>
    <org_study_id>Kuh-seng1.0</org_study_id>
    <nct_id>NCT02239237</nct_id>
  </id_info>
  <brief_title>Post-marketing Safety Surveillance of Compound Kuh-seng Injection: a Registry Study</brief_title>
  <official_title>Post-marketing Safety Surveillance of Compound Kuh-seng Injection: a Registry Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhong Wang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanxi Zhendong pharmaceutical Co. LTD.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>China Academy of Chinese Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This registry aims to monitor the safety of Compound Kuh-seng Injection and to identify the&#xD;
      potential risk factors for the adverse drug reactions. Compound Kuh-seng Injection is a kind&#xD;
      of natural compound injection extracted from herbs Kuh-seng (Radix Sophorae Flavescentis) and&#xD;
      Rhizoma Heterosmilacis Japonicae.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">October 2018</completion_date>
  <primary_completion_date type="Actual">June 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of severe adverse reactions (SAR) to the Compound Kuh-seng Injection</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidence of adverse drug reactions (ADR) to Compound Kuh-seng Injection</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of anaphylactic reaction to Compound Kuh-seng Injection</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of new ADRs to Compound Kuh-seng Injection</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of new SARs to Compound Kuh-seng Injection</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30283</enrollment>
  <condition>Safety Surveillance</condition>
  <condition>Adverse Drug Events</condition>
  <condition>Adverse Drug Reactions</condition>
  <condition>Severe Adverse Events</condition>
  <condition>Severe Adverse Reactions</condition>
  <arm_group>
    <arm_group_label>Compound Kuh-seng Injection</arm_group_label>
    <description>Compound Kuh-seng Injection will be given to the patients, and the investigators will record all the information including ADR, application of Compound Kuh-seng Injection and the combined medications, etc.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Compound Kuh-seng Injection</intervention_name>
    <description>Compound Kuh-seng Injection is a kind of natural compound injection extracted from Chinese herbs Kuh-seng (Radix Sophorae Flavescentis) and Rhizoma Heterosmilacis Japonicae. The major bioactive ingredients include oxymatrine，sophocarpidine, matrine, flavonoid etc.</description>
    <arm_group_label>Compound Kuh-seng Injection</arm_group_label>
    <other_name>Compound Kushen Injection</other_name>
    <other_name>Fufang Kushen Zhusheye</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum will be retained from the patients who have the anaphylaxis after given the Compound&#xD;
      Kuh-seng Injection and the other 4 matched patients who do not has the anaphylaxis.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who use Compound Kushen Injection in the monitoring hospitals&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who use Compound Kushen Injection in the monitoring hospitals&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhong Wang, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zhan-Yu Pan, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tianjin medical university cancer institute &amp; hosptial</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HanDan Central Hospital</name>
      <address>
        <city>HanDan</city>
        <state>Hebei</state>
        <zip>056001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Handan First Hospital</name>
      <address>
        <city>Handan</city>
        <state>Hebei</state>
        <zip>056002</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bai Qiu'en International Peace Hospital</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050082</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan University Huaihe Hospital</name>
      <address>
        <city>Kaifeng</city>
        <state>Henan</state>
        <zip>475001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Henan University of Science &amp; Technology</name>
      <address>
        <city>Luoyang</city>
        <state>Henan</state>
        <zip>471000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Luoyang Central Hospital Affiliated to Zhengzhou University</name>
      <address>
        <city>Luoyang</city>
        <state>Henan</state>
        <zip>471009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xinxiang Central Hospital</name>
      <address>
        <city>Xinxiang</city>
        <state>Henan</state>
        <zip>453000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xinxiang Medical University</name>
      <address>
        <city>Xinxiang</city>
        <state>Henan</state>
        <zip>453199</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xinyang Central Hospital</name>
      <address>
        <city>Xinyang</city>
        <state>Henan</state>
        <zip>464000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>People's Hospital of Zhengzhou</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Cancer Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Henan College of Traditional Chinese Medicine</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>451199</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shandong Provincial Western Hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qingdao Center Hospital</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <zip>266031</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tai'an Central Hospital</name>
      <address>
        <city>Tai'an</city>
        <state>Shandong</state>
        <zip>271000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The 88th Hospital of People's Liberation Army</name>
      <address>
        <city>Tai'an</city>
        <state>Shandong</state>
        <zip>271002</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>People's Hospital of Xintai City</name>
      <address>
        <city>Tai'an</city>
        <state>Shandong</state>
        <zip>271200</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weifang No.2 People's Hospital</name>
      <address>
        <city>Weifang</city>
        <state>Shandong</state>
        <zip>261041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weihai Municipal Hospital</name>
      <address>
        <city>Weihai</city>
        <state>Shandong</state>
        <zip>264299</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Hospital of Zibo</name>
      <address>
        <city>Zibo</city>
        <state>Shandong</state>
        <zip>255020</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jincheng General Hospital</name>
      <address>
        <city>Jincheng</city>
        <state>Shanxi</state>
        <zip>048006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Fourth People's Hospital of Linfen</name>
      <address>
        <city>Linfen</city>
        <state>Shanxi</state>
        <zip>041099</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Traditional Chinese Hospital of Shanxi</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030012</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yuncheng Central Hospital</name>
      <address>
        <city>Yuncheng</city>
        <state>Shanxi</state>
        <zip>044099</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chengdu Second People's Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610017</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AVIC 363 Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teaching Hospital of Chengdu University of T.C.M.</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610072</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second People's Hospital of Yibin</name>
      <address>
        <city>Yibin</city>
        <state>Sichuan</state>
        <zip>644000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin medical university cancer institute &amp; hosptial</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>October 9, 2018</last_update_submitted>
  <last_update_submitted_qc>October 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>China Academy of Chinese Medical Sciences</investigator_affiliation>
    <investigator_full_name>Zhong Wang</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Drug-Related Side Effects and Adverse Reactions</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/NCT02239237
org study id: Kuh-seng1.0
nct id: NCT02239237
lead sponsor: 
collaborator: 
has dmc: Yes
This registry aims to monitor the safety of Compound Kuh-seng Injection and to identify the
      potential risk factors for the adverse drug reactions. Compound Kuh-seng Injection is a kind
      of natural compound injection extracted from herbs Kuh-seng (Radix Sophorae Flavescentis) and
      Rhizoma Heterosmilacis Japonicae.
observational model: Cohort
time perspective: Prospective
measure: The incidence of severe adverse reactions (SAR) to the Compound Kuh-seng Injection
time frame: 2 years
measure: The incidence of adverse drug reactions (ADR) to Compound Kuh-seng Injection
time frame: 2 years
measure: The incidence of anaphylactic reaction to Compound Kuh-seng Injection
time frame: 2 years
measure: The incidence of new ADRs to Compound Kuh-seng Injection
time frame: 2 years
measure: The incidence of new SARs to Compound Kuh-seng Injection
time frame: 2 years
arm group label: Compound Kuh-seng Injection
description: Compound Kuh-seng Injection will be given to the patients, and the investigators will record all the information including ADR, application of Compound Kuh-seng Injection and the combined medications, etc.
intervention type: Drug
intervention name: Compound Kuh-seng Injection
description: Compound Kuh-seng Injection is a kind of natural compound injection extracted from Chinese herbs Kuh-seng (Radix Sophorae Flavescentis) and Rhizoma Heterosmilacis Japonicae. The major bioactive ingredients include oxymatrine，sophocarpidine, matrine, flavonoid etc.
arm group label: Compound Kuh-seng Injection
other name: Compound Kushen Injection
other name: Fufang Kushen Zhusheye
Serum will be retained from the patients who have the anaphylaxis after given the Compound
      Kuh-seng Injection and the other 4 matched patients who do not has the anaphylaxis.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Zhong Wang, M.D.
role: Study Director
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
last name: Zhan-Yu Pan, Ph.D.
role: Principal Investigator
affiliation: Tianjin medical university cancer institute & hosptial
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country: China
responsible party type: Sponsor-Investigator
investigator affiliation: China Academy of Chinese Medical Sciences
investigator full name: Zhong Wang
investigator title: Dr
mesh term: Drug-Related Side Effects and Adverse Reactions