<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/NCT03228134</url>
  </required_header>
  <id_info>
    <org_study_id>2017LCSY347</org_study_id>
    <nct_id>NCT03228134</nct_id>
  </id_info>
  <brief_title>Clinical Study on Treatment of Chronic Persistent Bronchial Asthma</brief_title>
  <official_title>Clinical Study on Treatment of Chronic Persistent Bronchial Asthma With Integrated Traditional Chinese and Western Medicine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Longhua Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai University of Traditional Chinese Medicine</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>
      Investigators aimed to evaluate the clinical efficacy of integrated traditional Chinese and&#xD;
      Western medicine in the treatment of asthma, and to further optimize the prescription of&#xD;
      Chinese medicine treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The incidence of asthma in China is high and the rate of control is low. Traditional Chinese&#xD;
      medicine has a long history of treating asthma, and has a good clinical curative effect.The&#xD;
      purpose of this study is to evaluate the clinical efficacy of traditional Chinese medicine in&#xD;
      the treatment of asthma, and to further optimize the prescription of Chinese medicine&#xD;
      treatment.&#xD;
&#xD;
      In this study, investigators recruited chronic persistent asthma participants, and gave the&#xD;
      corresponding western medicine background treatment and traditional Chinese medicine&#xD;
      treatment program for 28 days.Participants will undergo a physical examination, lung&#xD;
      function, blood and sputum collection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>All treatment group received traditional chinese medicine plus a standard anti-asthma treatment on study entry, and the control group received placebo and standard anti-asthma treatment.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>Double-blind trial</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Asthma control rate change</measure>
    <time_frame>up to 4 weeks</time_frame>
    <description>Measured the change from Baseline of asthma control rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lung function(FEV1, PEF)</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Measured routine pulmonary ventilation function test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FeNO</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>The fractional concentration of exhaled nitric oxide</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood routine examination</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Hematological routine examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver function test</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Simple liver function test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokine levels of induced sputum</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Measured cytokine levels of induced sputum supernatant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kidney function test</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Simple kidney function test</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">320</enrollment>
  <condition>Bronchial Asthma</condition>
  <arm_group>
    <arm_group_label>Hanxiao treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>80 patients belongs to Hanxiao type of asthma will take Ke Chuan Liu Wei Granule oral therapy twice everyday for 28 days and receive background therapy of ICS and beta2-agonist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hanxiao control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>80 patients belongs to Hanxiao type of asthma will take Ke Chuan Liu Wei Granule placebo oral therapy twice everyday for 28 days and receive background therapy of ICS and beta2-agonist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Xuxiao treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>80 patients of deficiency type of asthma will take Yang He Ping Chuan Granule oral therapy thrice everyday for 28 days and background therapy of ICS and beta2-agonist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Xuxiao control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>80 patients of deficiency type of asthma will take Yang He Ping Chuan Granule placebo oral therapy thrice everyday for 28 days and background therapy of ICS and beta2-agonist.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ke Chuan Liu Wei Granule</intervention_name>
    <description>Traditional Chinese Medicine</description>
    <arm_group_label>Hanxiao treatment group</arm_group_label>
    <other_name>KCLW Granule</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Yang He Ping Chuan Granule</intervention_name>
    <description>Traditional Chinese Medicine</description>
    <arm_group_label>Xuxiao treatment group</arm_group_label>
    <other_name>YHPC Granule</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ke Chuan Liu Wei Granule placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Hanxiao control group</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Yang He Ping Chuan Granule placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Xuxiao control group</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient diagnosed with chronic persistent asthma&#xD;
&#xD;
          -  Patients had positive bronchodilator reversibility test or positive bronchial&#xD;
             challenge test or more than 50 parts per billion of FENO before&#xD;
&#xD;
          -  Conform to the predetermined 2 TCM Syndrome Types&#xD;
&#xD;
          -  Patients who have given written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoking and continuous exposure to hazardous environment&#xD;
&#xD;
          -  With fever, or severity of intermittent state, high degree of sustained, or with&#xD;
             respiratory failure, etc.&#xD;
&#xD;
          -  Pulmonary emphysema, chronic obstructive pulmonary disease, pulmonary emphysema,&#xD;
             pulmonary heart disease, pneumonia, lung cancer and other lung diseases&#xD;
&#xD;
          -  Patients who are allergic to therapeutic medicine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Huiyong Zhang, Director</last_name>
    <role>Principal Investigator</role>
    <affiliation>tcmdoctorzhang@163.com</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zifeng Ma, Doctor</last_name>
    <phone>+8621-64385700</phone>
    <phone_ext>1307</phone_ext>
    <email>mzf05@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhenghui Lu, PHD</last_name>
    <phone>+8621-64385700</phone>
    <phone_ext>1307</phone_ext>
    <email>tcmdoctorlu@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fenglin Street Community Health Service Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chuntao Yi, Master</last_name>
      <phone>+8618817338803</phone>
      <email>yichuntao@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kangjian Street Community Health Service Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Taiquan Huang, Master</last_name>
      <phone>+8613918375404</phone>
      <email>tqh957@sina.com.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tianping Street Community Health Service Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Xin He, Master</last_name>
      <phone>+8613501903509</phone>
      <email>hexin2050@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Longhua Hospital Affiliated Shanghai University of TCM</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zifeng Ma, Master</last_name>
      <phone>+8618817338863</phone>
      <email>mzf05@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fengxian District Hospital of TCM</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>201400</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fang Fang, Master</last_name>
      <phone>+8613816856217</phone>
      <email>13816856217@139.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>July 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>May 24, 2023</last_update_submitted>
  <last_update_submitted_qc>May 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>treatment； bronchial asthma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</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/NCT03228134
org study id: 2017LCSY347
nct id: NCT03228134
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Investigators aimed to evaluate the clinical efficacy of integrated traditional Chinese and
      Western medicine in the treatment of asthma, and to further optimize the prescription of
      Chinese medicine treatment.
The incidence of asthma in China is high and the rate of control is low. Traditional Chinese
      medicine has a long history of treating asthma, and has a good clinical curative effect.The
      purpose of this study is to evaluate the clinical efficacy of traditional Chinese medicine in
      the treatment of asthma, and to further optimize the prescription of Chinese medicine
      treatment.

      In this study, investigators recruited chronic persistent asthma participants, and gave the
      corresponding western medicine background treatment and traditional Chinese medicine
      treatment program for 28 days.Participants will undergo a physical examination, lung
      function, blood and sputum collection.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: All treatment group received traditional chinese medicine plus a standard anti-asthma treatment on study entry, and the control group received placebo and standard anti-asthma treatment.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: Double-blind trial
measure: Asthma control rate change
time frame: up to 4 weeks
description: Measured the change from Baseline of asthma control rate
measure: Lung function(FEV1, PEF)
time frame: Up to 4 weeks
description: Measured routine pulmonary ventilation function test
measure: FeNO
time frame: Up to 4 weeks
description: The fractional concentration of exhaled nitric oxide
measure: Blood routine examination
time frame: Up to 4 weeks
description: Hematological routine examination
measure: Liver function test
time frame: Up to 4 weeks
description: Simple liver function test
measure: Cytokine levels of induced sputum
time frame: Up to 4 weeks
description: Measured cytokine levels of induced sputum supernatant
measure: Kidney function test
time frame: Up to 4 weeks
description: Simple kidney function test
arm group label: Hanxiao treatment group
arm group type: Experimental
description: 80 patients belongs to Hanxiao type of asthma will take Ke Chuan Liu Wei Granule oral therapy twice everyday for 28 days and receive background therapy of ICS and beta2-agonist.
arm group label: Hanxiao control group
arm group type: Sham Comparator
description: 80 patients belongs to Hanxiao type of asthma will take Ke Chuan Liu Wei Granule placebo oral therapy twice everyday for 28 days and receive background therapy of ICS and beta2-agonist.
arm group label: Xuxiao treatment group
arm group type: Experimental
description: 80 patients of deficiency type of asthma will take Yang He Ping Chuan Granule oral therapy thrice everyday for 28 days and background therapy of ICS and beta2-agonist.
arm group label: Xuxiao control group
arm group type: Sham Comparator
description: 80 patients of deficiency type of asthma will take Yang He Ping Chuan Granule placebo oral therapy thrice everyday for 28 days and background therapy of ICS and beta2-agonist.
intervention type: Drug
intervention name: Ke Chuan Liu Wei Granule
description: Traditional Chinese Medicine
arm group label: Hanxiao treatment group
other name: KCLW Granule
intervention type: Drug
intervention name: Yang He Ping Chuan Granule
description: Traditional Chinese Medicine
arm group label: Xuxiao treatment group
other name: YHPC Granule
intervention type: Other
intervention name: Ke Chuan Liu Wei Granule placebo
description: Placebo
arm group label: Hanxiao control group
other name: Placebo
intervention type: Other
intervention name: Yang He Ping Chuan Granule placebo
description: Placebo
arm group label: Xuxiao control group
other name: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Huiyong Zhang, Director
role: Principal Investigator
affiliation: tcmdoctorzhang@163.com
last name: Zifeng Ma, Doctor
phone: +8621-64385700
phone ext: 1307
email: mzf05@126.com
last name: Zhenghui Lu, PHD
phone: +8621-64385700
phone ext: 1307
email: tcmdoctorlu@163.com
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Asthma