<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/NCT03299322</url>
  </required_header>
  <id_info>
    <org_study_id>2016LCSY098</org_study_id>
    <nct_id>NCT03299322</nct_id>
  </id_info>
  <brief_title>A Study to Assess Jia Wei Yang He Formula as a Plus Therapy in the Treatment of Persistent Asthma</brief_title>
  <official_title>Clinical Assessment of Jia Wei Yang He Formula as a Plus Therapy in the Treatment of Persistent Asthma and Airway Microbiome Exploration Research</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fudan University</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 assess Jia Wei Yang He Formula as a plus therapy in the treatment of&#xD;
      persistent asthma and to explore Airway Microbiome variation of Asthma by Traditional Chinese&#xD;
      Medicine treatment&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Asthma is a common chronic inflammatory respiratory disease, patients showed high airway&#xD;
      reactivity, and the clinical manifestations of recurrent wheezing, shortness of breath, chest&#xD;
      tightness or cough with wheezing dyspnea mainly for a breath. Although many studies have&#xD;
      shown that viral infections may be an important cause of asthma seasonal attacks. However,&#xD;
      more and more studies have shown that bacterial infection is an important risk factor for&#xD;
      asthma. Haemophilus influenzae, Moraxella Mora bacteria infection may increase the risk of&#xD;
      asthma by a research report.&#xD;
&#xD;
      Chinese medicine decoction, as a common treatment for asthma, can significantly alleviate&#xD;
      seasonal attacks and reduce the number of acute attacks. Research shows that Chinese medicine&#xD;
      has widely immunomodulatory effects and imbalance of immune system in patients with asthma&#xD;
      control, improve the cellular immunity of patients with airway and defense function,&#xD;
      significantly reduced asthma attacks of which induced by upper airway infection or chronic&#xD;
      persist asthma.&#xD;
&#xD;
      This study will be conducted for 4 weeks of standard anti-asthma treatment plus Jia Wei Yang&#xD;
      He Formula for patients.Some patients are not willing to use standard treatment such as&#xD;
      inhaled corticosteroids and long-acting β-adrenoceptor agonists because of side effects. We&#xD;
      will provide these patients free JWYH formula after the efficacy of the JWYH is validated and&#xD;
      the subsequent results are considered exploratory.&#xD;
&#xD;
      Participants will undergo a physical examination, lung function, blood and sputum collection&#xD;
      and all induced sputum samples will be detected by 16S ribosomal RNA (16S rRNA) sequencing&#xD;
      and analyzed for microbial bioinformatics. To study whether there is association between the&#xD;
      efficacy of Jia Wei Yang He Formula and the changes in microbiota composition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</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 a standard anti-asthma treatment plus Jia Wei Yang He Formula on study entry, and the control group received Jia Wei Yang He Formula placebo instead.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>This is a Double-blind Trial</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Asthma Control Test Score variation</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Measured the change from Baseline to the end of treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Airway microbial diversity</measure>
    <time_frame>Baseline, 2 weeks and 4weeks</time_frame>
    <description>Measured by 16S rRNA sequencing of induces sputum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary function tests</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Measured the change from Baseline to the end of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fractional exhaled nitric oxide (FeNO)</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Measured the change from Baseline to the end of treatment of exhaled nitric oxide</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morning and evening Peak Expiratory Flow (PEF)</measure>
    <time_frame>Measured during the 4 weeks treatment period</time_frame>
    <description>Measured the change from Baseline to the end of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokine levels of serum</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Measured the change from Baseline to the end of treatment</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Bronchial Asthma</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>80 participants will take oral therapy of 9.25 g Jia Wei Yang He granule Placebo twice a day for 28 consecutive days and also standard therapy of inhaled corticosteroid or beta2-agonist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in high Jia Wei Yang He formula group will receive Jia Wei Yang He granule 18.5g twice a day for 28 consecutive days and also standard therapy of inhaled corticosteroid or beta2-agonist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low dose Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in high Jia Wei Yang He formula group will receive Jia Wei Yang He granule 9.25g twice a day for 28 consecutive days and also standard therapy of inhaled corticosteroid or beta2-agonist.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Jia Wei Yang He granule</intervention_name>
    <description>This is an empirical traditional Chinese medicine compound used in the treatment of asthma for a long time</description>
    <arm_group_label>High dose Treatment Group</arm_group_label>
    <arm_group_label>Low dose Treatment Group</arm_group_label>
    <other_name>Jia Wei Yang He Formula</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Jia Wei Yang He granule Placebo</intervention_name>
    <description>Made from 1/20 doses which has certain taste, but no therapeutic effect</description>
    <arm_group_label>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;
          -  Annual uncontrollable time ≥ 3 months&#xD;
&#xD;
          -  Patients who have given written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of upper upper/lower respiratory infection in the previous 1 months&#xD;
&#xD;
          -  History of long-term controller medication use for asthma (oral corticosteroid or&#xD;
             intravenous corticosteroids therapy) within the preceding 1 months&#xD;
&#xD;
          -  History of antibiotic use in the previous 1 months&#xD;
&#xD;
          -  History of life-threatening asthma&#xD;
&#xD;
          -  History of chronic lung diseases other than asthma, including but not limited to&#xD;
             chronic obstructive pulmonary disease, bronchiectasis, emphysema, tuberculosis,&#xD;
             sarcoidosis, pulmonary fibrosis, lung cancer, etc&#xD;
&#xD;
          -  History of serious disease of the heart and cerebrovascular disease&#xD;
&#xD;
          -  History of severe liver or renal dysfunction or disease&#xD;
&#xD;
          -  History of severe disease in the hematopoietic system&#xD;
&#xD;
          -  History of immunodeficiency (including, but not limited to, HIV positive detection, or&#xD;
             other acquired or congenital immunodeficiency disease, or organ transplant history)&#xD;
&#xD;
          -  History of any other condition (such as known drug or alcohol abuse or psychiatric&#xD;
             disorder) which, in the opinion of the investigator, may preclude the patient from&#xD;
             following and completing the protocol&#xD;
&#xD;
          -  Are currently enrolled in, or discontinued within the last 30 days from, a clinical&#xD;
             trial involving an investigational product or non-approved use of a drug or device&#xD;
             (other than the investigational product used in this study), or concurrently enrolled&#xD;
             in any other type of medical research judged not to be scientifically or medically&#xD;
             compatible with this study&#xD;
&#xD;
          -  History of allergies to the component of the investigated drugs&#xD;
&#xD;
          -  Smoking within the past year&#xD;
&#xD;
          -  Contraindication to induced sputum collection method on history or examination&#xD;
&#xD;
          -  Any serious medical condition which, in the opinion of the Investigator, would pose a&#xD;
             significant risk to the patient or interfere with the interpretation of safety,&#xD;
             efficacy, or pharmacodynamic data&#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, Master</last_name>
    <role>Study Chair</role>
    <affiliation>Longhua Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zifeng Ma, Master</last_name>
    <phone>+8621-64385700</phone>
    <phone_ext>1307</phone_ext>
    <email>mzf05@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhenhui Lu, Doctor</last_name>
    <phone>+8621-64385700</phone>
    <phone_ext>1307</phone_ext>
    <email>tcmdoctorlu@163.com</email>
  </overall_contact_backup>
  <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>Jiyou Fu, master</last_name>
      <phone>+8618917763366</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fengxian District traditional Chinese medicine hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Donghua Zhou</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jingan district center hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Huifang Cao</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pudong Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Hong Bao</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai eighth people's hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Dejie Chu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai TCM-Integrated Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Wei Jia</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xuhui district center hospita</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ronghuan Yu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital affiliated fudan university</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Changzhou Shao</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 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>Bronchial Asthma，TCM，microorganism</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/NCT03299322
org study id: 2016LCSY098
nct id: NCT03299322
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Investigators aimed to assess Jia Wei Yang He Formula as a plus therapy in the treatment of
      persistent asthma and to explore Airway Microbiome variation of Asthma by Traditional Chinese
      Medicine treatment
Asthma is a common chronic inflammatory respiratory disease, patients showed high airway
      reactivity, and the clinical manifestations of recurrent wheezing, shortness of breath, chest
      tightness or cough with wheezing dyspnea mainly for a breath. Although many studies have
      shown that viral infections may be an important cause of asthma seasonal attacks. However,
      more and more studies have shown that bacterial infection is an important risk factor for
      asthma. Haemophilus influenzae, Moraxella Mora bacteria infection may increase the risk of
      asthma by a research report.

      Chinese medicine decoction, as a common treatment for asthma, can significantly alleviate
      seasonal attacks and reduce the number of acute attacks. Research shows that Chinese medicine
      has widely immunomodulatory effects and imbalance of immune system in patients with asthma
      control, improve the cellular immunity of patients with airway and defense function,
      significantly reduced asthma attacks of which induced by upper airway infection or chronic
      persist asthma.

      This study will be conducted for 4 weeks of standard anti-asthma treatment plus Jia Wei Yang
      He Formula for patients.Some patients are not willing to use standard treatment such as
      inhaled corticosteroids and long-acting β-adrenoceptor agonists because of side effects. We
      will provide these patients free JWYH formula after the efficacy of the JWYH is validated and
      the subsequent results are considered exploratory.

      Participants will undergo a physical examination, lung function, blood and sputum collection
      and all induced sputum samples will be detected by 16S ribosomal RNA (16S rRNA) sequencing
      and analyzed for microbial bioinformatics. To study whether there is association between the
      efficacy of Jia Wei Yang He Formula and the changes in microbiota composition.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: All treatment group received a standard anti-asthma treatment plus Jia Wei Yang He Formula on study entry, and the control group received Jia Wei Yang He Formula placebo instead.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: This is a Double-blind Trial
measure: Asthma Control Test Score variation
time frame: Baseline and 4 weeks
description: Measured the change from Baseline to the end of treatment
measure: Airway microbial diversity
time frame: Baseline, 2 weeks and 4weeks
description: Measured by 16S rRNA sequencing of induces sputum
measure: Pulmonary function tests
time frame: Baseline and 4 weeks
description: Measured the change from Baseline to the end of treatment
measure: Fractional exhaled nitric oxide (FeNO)
time frame: Baseline and 4 weeks
description: Measured the change from Baseline to the end of treatment of exhaled nitric oxide
measure: Morning and evening Peak Expiratory Flow (PEF)
time frame: Measured during the 4 weeks treatment period
description: Measured the change from Baseline to the end of treatment
measure: Cytokine levels of serum
time frame: Baseline and 4 weeks
description: Measured the change from Baseline to the end of treatment
arm group label: Control Group
arm group type: Placebo Comparator
description: 80 participants will take oral therapy of 9.25 g Jia Wei Yang He granule Placebo twice a day for 28 consecutive days and also standard therapy of inhaled corticosteroid or beta2-agonist.
arm group label: High dose Treatment Group
arm group type: Experimental
description: Participants in high Jia Wei Yang He formula group will receive Jia Wei Yang He granule 18.5g twice a day for 28 consecutive days and also standard therapy of inhaled corticosteroid or beta2-agonist.
arm group label: Low dose Treatment Group
arm group type: Experimental
description: Participants in high Jia Wei Yang He formula group will receive Jia Wei Yang He granule 9.25g twice a day for 28 consecutive days and also standard therapy of inhaled corticosteroid or beta2-agonist.
intervention type: Drug
intervention name: Jia Wei Yang He granule
description: This is an empirical traditional Chinese medicine compound used in the treatment of asthma for a long time
arm group label: High dose Treatment Group
arm group label: Low dose Treatment Group
other name: Jia Wei Yang He Formula
intervention type: Drug
intervention name: Jia Wei Yang He granule Placebo
description: Made from 1/20 doses which has certain taste, but no therapeutic effect
arm group label: Control Group
other name: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Huiyong Zhang, Master
role: Study Chair
affiliation: Longhua Hospital
last name: Zifeng Ma, Master
phone: +8621-64385700
phone ext: 1307
email: mzf05@126.com
last name: Zhenhui Lu, Doctor
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: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Asthma