<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/NCT04479553</url>
  </required_header>
  <id_info>
    <org_study_id>QZTL-V1.0</org_study_id>
    <nct_id>NCT04479553</nct_id>
  </id_info>
  <brief_title>Post-marketing Safety Surveillance of Qizhi Tongluo Capsules:a Registry Study.</brief_title>
  <official_title>Post-marketing Safety Surveillance of Qizhi Tongluo Capsules:a Registry Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhong Wang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanxi Zhendong Pharmacy Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>China Academy of Chinese Medical Sciences</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>
      This registry aims to monitor the safety of Qizhi Tongluo Capsules and to identify the&#xD;
      potential risk factors for its adverse drug reactions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 17, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>The incidence of adverse drug reactions (ADR) to the Qizhi Tongluo Capsules</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidence of adverse drug event (ADE) to the Qizhi Tongluo Capsules</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of new ADRs to the Qizhi Tongluo Capsules</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of serious adverse drug event (SADE) to the Qizhi Tongluo Capsules</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in biological indicators of patients with serious adverse events</measure>
    <time_frame>3 years</time_frame>
    <description>Patients with serious adverse events and suspected unintended serious adverse reactions should be tested for liver function (ALT, AST, ALP, TBIL, DBIL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in biological indicators of patients with serious adverse events</measure>
    <time_frame>3 years</time_frame>
    <description>Patients with serious adverse events and suspected unintended serious adverse reactions should be tested for renal function (BUN, SCr, UA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in biological indicators of patients with serious adverse events</measure>
    <time_frame>3 years</time_frame>
    <description>Patients with serious adverse events and suspected unintended serious adverse reactions should be tested for immune indicators (IgA, IgE, T-lymphocyte, B lymphocyte, cell surface antigen, serum histamine concentration and complement).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30000</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>Qizhi Tongluo Capsules</arm_group_label>
    <description>Qizhi Tongluo Capsules will be given to the patients, and the investigators will record all the information including ADR, application of Qizhi Tongluo Capsules and the combined medications, etc.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Qizhi Tongluo Capsules</intervention_name>
    <description>Qizhi Tongluo Capsule, a Chinese patent medicine composed of 26 Chinese herbs, has been approved by China Food and Drug Administration for treating recovery period of ischemic stroke (drug approval numbers: B20171001).</description>
    <arm_group_label>Qizhi Tongluo Capsules</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      1. The blood routine, urine routine, and stool routine before and after medication need to&#xD;
           be obtained in the patients with adverse events&#xD;
&#xD;
        2. The level of the liver functional indicators (including ALT,AST,ALP,TBIL,DBIL) the renal&#xD;
           functional indicators (including BUN,SCr,UA) and the immune indicators (including&#xD;
           IgA，IgE,the counts of T lymphocyte and B lymphocyte,CD3，CD4，CD8，CD20,serum histamine&#xD;
           concentration,C3,C4) should be obtained in patients with serious adverse events and&#xD;
           suspicious unexpected serious adverse reactions.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who use Qizhi Tongluo Capsules in the monitoring hospitals.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who use Qizhi Tongluo Capsules 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_contact>
    <last_name>Zhong Wang</last_name>
    <phone>86-10-64093207</phone>
    <email>zhonw@vip.sina.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ningming County Hospital of Chinese Medicine</name>
      <address>
        <city>Changzuo</city>
        <state>Guangxi</state>
        <zip>532500</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jie Liu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fangchenggang City Hospital of Chinese Medicine</name>
      <address>
        <city>Fangchenggang</city>
        <state>Guangxi</state>
        <zip>538021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Haizhen Pan</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Guangxi University of Chinese Medicine</name>
      <address>
        <city>Nanning</city>
        <state>Guangxi</state>
        <zip>530023</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peng Wu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanglin County Hospital of Chinese Medicine</name>
      <address>
        <city>Nanning</city>
        <state>Guangxi</state>
        <zip>530500</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guige Tan</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Long'an County Hospital of Chinese Medicine</name>
      <address>
        <city>Nanning</city>
        <state>Guangxi</state>
        <zip>532799</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhenming Lu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Luohe Hospital of traditional Chinese Medicine</name>
      <address>
        <city>Luohe</city>
        <state>Henan</state>
        <zip>462000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yingmin Song</last_name>
      <phone>13623957063</phone>
      <email>sym26567@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Nanyang Medical College</name>
      <address>
        <city>Nanyang</city>
        <state>Henan</state>
        <zip>473000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Nanyang Medical College</name>
      <address>
        <city>Nanyang</city>
        <state>Henan</state>
        <zip>473000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wanqun Wang</last_name>
    </contact>
  </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>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ping Zhang</last_name>
      <email>zhangpingsjnk@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Henan University of traditional Chinese Medicine</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Xinzhi Wang</last_name>
      <phone>18638189355</phone>
      <email>znqznq@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Third Affiliated Hospital of Henan University of traditional Chinese Medicine</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Yanbian University</name>
      <address>
        <city>Yanbian</city>
        <state>Jilin</state>
        <zip>133000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Shandong University of Chinese Medicine</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250001</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xingchen Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Changzhi Institute of traditional Chinese Medicine</name>
      <address>
        <city>Changzhi</city>
        <state>Shanxi</state>
        <zip>046000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jinbin Guo</last_name>
      <phone>13111251707</phone>
      <email>changzhizynb@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>November 14, 2022</last_update_submitted>
  <last_update_submitted_qc>November 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2022</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>Professor</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/NCT04479553
org study id: QZTL-V1.0
nct id: NCT04479553
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This registry aims to monitor the safety of Qizhi Tongluo Capsules and to identify the
      potential risk factors for its adverse drug reactions.
observational model: Cohort
time perspective: Prospective
measure: The incidence of adverse drug reactions (ADR) to the Qizhi Tongluo Capsules
time frame: 3 years
measure: The incidence of adverse drug event (ADE) to the Qizhi Tongluo Capsules
time frame: 3 years
measure: The incidence of new ADRs to the Qizhi Tongluo Capsules
time frame: 3 years
measure: The incidence of serious adverse drug event (SADE) to the Qizhi Tongluo Capsules
time frame: 3 years
measure: Changes in biological indicators of patients with serious adverse events
time frame: 3 years
description: Patients with serious adverse events and suspected unintended serious adverse reactions should be tested for liver function (ALT, AST, ALP, TBIL, DBIL)
measure: Changes in biological indicators of patients with serious adverse events
time frame: 3 years
description: Patients with serious adverse events and suspected unintended serious adverse reactions should be tested for renal function (BUN, SCr, UA)
measure: Changes in biological indicators of patients with serious adverse events
time frame: 3 years
description: Patients with serious adverse events and suspected unintended serious adverse reactions should be tested for immune indicators (IgA, IgE, T-lymphocyte, B lymphocyte, cell surface antigen, serum histamine concentration and complement).
arm group label: Qizhi Tongluo Capsules
description: Qizhi Tongluo Capsules will be given to the patients, and the investigators will record all the information including ADR, application of Qizhi Tongluo Capsules and the combined medications, etc.
intervention type: Drug
intervention name: Qizhi Tongluo Capsules
description: Qizhi Tongluo Capsule, a Chinese patent medicine composed of 26 Chinese herbs, has been approved by China Food and Drug Administration for treating recovery period of ischemic stroke (drug approval numbers: B20171001).
arm group label: Qizhi Tongluo Capsules
1. The blood routine, urine routine, and stool routine before and after medication need to
           be obtained in the patients with adverse events

        2. The level of the liver functional indicators (including ALT,AST,ALP,TBIL,DBIL) the renal
           functional indicators (including BUN,SCr,UA) and the immune indicators (including
           IgA，IgE,the counts of T lymphocyte and B lymphocyte,CD3，CD4，CD8，CD20,serum histamine
           concentration,C3,C4) should be obtained in patients with serious adverse events and
           suspicious unexpected serious adverse reactions.
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
phone: 86-10-64093207
email: zhonw@vip.sina.com
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: China Academy of Chinese Medical Sciences
investigator full name: Zhong Wang
investigator title: Professor
mesh term: Drug-Related Side Effects and Adverse Reactions