<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/NCT04457011</url>
  </required_header>
  <id_info>
    <org_study_id>TSL-TCM-SSXEZKKL-Ⅱ</org_study_id>
    <nct_id>NCT04457011</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Susu Zhike Granules for Treating Acute Cough Due to Common Cold With Cold-cough Syndrome in Children</brief_title>
  <official_title>The Efficacy and Safety Evaluation of Susu Xiao'er Zhike Granules in the Treatment of the Cough Caused by the Common Cold(Wind Cold Cough Syndromes) in Children: a Randomized, Double-blind, Dose Exploration,Multi-center Phase II Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tasly Pharmaceutical Group Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tasly Pharmaceutical Group Co., Ltd</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This protocol is designed with the aim of exploring the efficacy of Susu on shortening&#xD;
      duration and reducing severity of cough, and observe the safety used in children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Susu used to be a clinical experienced Chinese herb formula for treating acute cough caused&#xD;
      by common cold. The ingredients includes Hua Ju Hong, Qiao Rui Su, Zi Su Ye, Jie Geng, Gan&#xD;
      Cao,which relieving cold and cough, resolving phlegm in traditional Chinese medicine theory.&#xD;
      This prescription was used for a long time in clinical for treatingacute cough caused by&#xD;
      common cold as an herb formula. To standardize the quality and make it easier to take, we&#xD;
      reproduced it into a patent medicine and design this trial for evaluating it.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 19, 2020</start_date>
  <completion_date type="Anticipated">April 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2022</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Resolution of cough/ resolution rate</measure>
    <time_frame>The median time of resolution of cough during Day 2-Day 6 and resolution rate of the last 24 hours.</time_frame>
    <description>Clinical cure is assessed based on visual analogue scale(VAS) score of cough severity, and defined as both VAS scores of day-time and night-time cough reduce to 17mm or less, and last for 24 hours. Day-time refers to 6AM-10PM, night-time refers to 10PM-6AM. The cough VAS is a 100mm line segment, its length represents cough severity (both cough frequent and tense should be considered). 0mm=no cough, 100mm=worst cough, seriously impacting life quality such as playing, going to school, sleeping.18 Day-time and night-time VAS are assessed independently on baseline (Day1) and Day 2-Day 6 to assess the severity of last 24 hours. Children will be trained to use this assessment tool after randomized, and will recorded it by themselves via dairy with the assistance of their parents.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to relief of cough</measure>
    <time_frame>The median time of relief of cough during Day 2-Day 6.</time_frame>
    <description>Day-time and night-time visual analogue scale(VAS) are assessed independently on baseline (Day1) and Day 2-Day 6 to assess the severity of last 24 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the cough VAS- Time Curve</measure>
    <time_frame>Baseline(Day1),Day 2-Day 6 post-treatment</time_frame>
    <description>Day-time and night-time visual analogue scale(VAS) are assessed independently on baseline (Day1) and Day 2-Day 6 to assess the severity of last 24 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent-proxy Children's Acute Cough-specific QoL Questionnaire(PAC-QoL) scale score</measure>
    <time_frame>Baseline(Day1),the last 24 hours post-treatment</time_frame>
    <description>PAC-QoL is a 16-iterm parent-proxy questionnaire to reflect the frequency of particular feelings and concerns or worries of parents, developed by team of Sophie Anderson James in Australia. 7 points Lkiert-type scale (very consistent, consistent, some consistent, general, some non-consistent, non-consistent, and very inconsistent, scoring 1-7, respectively) is used to assess the quality of life of past 24 hours. Lower scores shows greater frequency, concerns, or worries, with higher scores therefore reflecting better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall improvement of cough</measure>
    <time_frame>The last 24 hours post-treatment</time_frame>
    <description>It is assessed by parents, with the question of &quot;How is your child's cough severity changed after treatment?&quot;(compared with 6 days ago). The response includes much better, better, no difference, worse, much worse. It will be record on Day 6.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disappearance rate of Traditional Chinese Medicine(TCM) symptom</measure>
    <time_frame>Baseline(Day1),the last 24 hours post-treatment</time_frame>
    <description>TCM syndrome includes feverish, cough,intolerance of cold, headache, body ache, nasal congestion, sneezing, runny nose, pharyngeal itching.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Curative effect of Traditional Chinese Medicine(TCM) syndrome</measure>
    <time_frame>Baseline(Day1),the last 24 hours post-treatment</time_frame>
    <description>We will assess the cure rate of symptoms respectively and the total efficacy of traditional Chinese syndrome on Day 6 via the TCM syndrome scale. Cure is defined as the score of the independent symptom decreased to 0. Efficacy means the change from baseline of total score&gt;50%.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Cough</condition>
  <arm_group>
    <arm_group_label>High dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High dose Susu Xiao'er Zhike Granules, 1 bag, bid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Middle dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Middle dose Susu Xiao'er Zhike Granules, 1 bag, bid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Extremely-low dose group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Extremely-low dose Susu Xiao'er Zhike Granules, 1 bag, bid</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>High dose Susu Xiao'er Zhike Granules 1 bag</intervention_name>
    <description>High dose Susu Xiao'er Zhike Granules 1 bag(9g granule per bag,contains 20.25g crude herbs), twice a day (7-9a.m. and 5-7p.m.) for five days</description>
    <arm_group_label>High dose group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Middle dose Susu Xiao'er Zhike Granules 1 bag</intervention_name>
    <description>Middle dose Susu Xiao'er Zhike Granules 1 bag(9g granule per bag,contains 10.13g crude herbs), twice a day (7-9a.m. and 5-7p.m.) for five days</description>
    <arm_group_label>Middle dose group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Extremely-low dose Susu Xiao'er Zhike Granules 1 bag</intervention_name>
    <description>Extremely-low dose Susu Xiao'er Zhike Granules 1 bag(9g granule per bag,contains 0.51g crude herbs), twice a day (7-9a.m. and 5-7p.m.) for five days</description>
    <arm_group_label>Extremely-low dose group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed as common cold standard, and VAS score of daytime or night-time cough &gt;=&#xD;
             40mm;&#xD;
&#xD;
          -  Diagnosed as wind cold cough syndrome;&#xD;
&#xD;
          -  Aged 6-14 ( &lt; 14) years;&#xD;
&#xD;
          -  The course of cough is &lt;= 48 hours;&#xD;
&#xD;
          -  The maximum temperature is &lt;= 38 degree C within 24 hours before visit;&#xD;
&#xD;
          -  The informed consent process complies with the requirement,and the legal&#xD;
             representative and the child (&gt;= 8 years old) sign the informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Accompanied by sore throat, obvious fever;&#xD;
&#xD;
          -  The white blood cell count(WBC), absolute value of neutrophils(NEU) and c-reactive&#xD;
             protein(CRP) all exceeded 1.2 times of the upper limit of the reference value, and the&#xD;
             researchers considered bacterial infection;&#xD;
&#xD;
          -  With complication, such as otitis media, sinusitis, acute bronchitis, pneumonia;&#xD;
&#xD;
          -  Acute bronchitis, pneumonia have been cured less than 8 weeks;&#xD;
&#xD;
          -  With a medical history of seasonal or perennial allergic rhinitis, chronic sinusitis,&#xD;
             chronic otitis media, bronchial asthma, chronic cough or recurrent respiratory tract&#xD;
             infection;&#xD;
&#xD;
          -  Patients with severe malnutrition;&#xD;
&#xD;
          -  Patients with other serious systemic diseases of the cardiovascular, brain, liver,&#xD;
             kidney and hematopoietic systems, any anatomical or respiratory abnormalities or&#xD;
             mental disorders;&#xD;
&#xD;
          -  Allergic to the experimental drugs;&#xD;
&#xD;
          -  Received antihistamines or any cough medicine, oral or inhaled steroid preparation&#xD;
             before enrollment;&#xD;
&#xD;
          -  The investigator considers it inappropriate to participate in this clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Rui Liu</last_name>
    <phone>022-86343626</phone>
    <email>liurui2@tasly.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Xiamen Hospital of Traditional Chinese Medicine</name>
      <address>
        <city>Xiamen</city>
        <state>Fujian</state>
        <zip>361001</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yubin Chen</last_name>
      <phone>0592-5579686</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hubei Provincial Hospital of TCM</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430073</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xixiong Xiang</last_name>
      <phone>027-88920837</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Hunan University of Traditional Chinese Medicine</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410007</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mengqing Wang</last_name>
      <phone>0371-85600717</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai Hospital of Traditional Chinese Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200071</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zheng Xue</last_name>
      <phone>021-56639828</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Chengdu University of Traditional Chinese Medicine</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>646000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kun Yang</last_name>
      <phone>028-87783407</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Teaching Hospital of Tianjin University of TCM</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300381</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xinmin Li</last_name>
      <phone>022-27986368</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Yunnan Provincial Hospital of TCM</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <zip>650021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ping He</last_name>
      <phone>0871-3632023</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>September 27, 2020</last_update_submitted>
  <last_update_submitted_qc>September 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Susu zhike granules</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Common Cold</mesh_term>
    <mesh_term>Cough</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/NCT04457011
org study id: TSL-TCM-SSXEZKKL-Ⅱ
nct id: NCT04457011
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This protocol is designed with the aim of exploring the efficacy of Susu on shortening
      duration and reducing severity of cough, and observe the safety used in children.
Susu used to be a clinical experienced Chinese herb formula for treating acute cough caused
      by common cold. The ingredients includes Hua Ju Hong, Qiao Rui Su, Zi Su Ye, Jie Geng, Gan
      Cao,which relieving cold and cough, resolving phlegm in traditional Chinese medicine theory.
      This prescription was used for a long time in clinical for treatingacute cough caused by
      common cold as an herb formula. To standardize the quality and make it easier to take, we
      reproduced it into a patent medicine and design this trial for evaluating it.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Time to Resolution of cough/ resolution rate
time frame: The median time of resolution of cough during Day 2-Day 6 and resolution rate of the last 24 hours.
description: Clinical cure is assessed based on visual analogue scale(VAS) score of cough severity, and defined as both VAS scores of day-time and night-time cough reduce to 17mm or less, and last for 24 hours. Day-time refers to 6AM-10PM, night-time refers to 10PM-6AM. The cough VAS is a 100mm line segment, its length represents cough severity (both cough frequent and tense should be considered). 0mm=no cough, 100mm=worst cough, seriously impacting life quality such as playing, going to school, sleeping.18 Day-time and night-time VAS are assessed independently on baseline (Day1) and Day 2-Day 6 to assess the severity of last 24 hours. Children will be trained to use this assessment tool after randomized, and will recorded it by themselves via dairy with the assistance of their parents.
measure: Time to relief of cough
time frame: The median time of relief of cough during Day 2-Day 6.
description: Day-time and night-time visual analogue scale(VAS) are assessed independently on baseline (Day1) and Day 2-Day 6 to assess the severity of last 24 hours.
measure: Area Under the cough VAS- Time Curve
time frame: Baseline(Day1),Day 2-Day 6 post-treatment
description: Day-time and night-time visual analogue scale(VAS) are assessed independently on baseline (Day1) and Day 2-Day 6 to assess the severity of last 24 hours.
measure: Parent-proxy Children's Acute Cough-specific QoL Questionnaire(PAC-QoL) scale score
time frame: Baseline(Day1),the last 24 hours post-treatment
description: PAC-QoL is a 16-iterm parent-proxy questionnaire to reflect the frequency of particular feelings and concerns or worries of parents, developed by team of Sophie Anderson James in Australia. 7 points Lkiert-type scale (very consistent, consistent, some consistent, general, some non-consistent, non-consistent, and very inconsistent, scoring 1-7, respectively) is used to assess the quality of life of past 24 hours. Lower scores shows greater frequency, concerns, or worries, with higher scores therefore reflecting better quality of life.
measure: Overall improvement of cough
time frame: The last 24 hours post-treatment
description: It is assessed by parents, with the question of "How is your child's cough severity changed after treatment?"(compared with 6 days ago). The response includes much better, better, no difference, worse, much worse. It will be record on Day 6.
measure: Disappearance rate of Traditional Chinese Medicine(TCM) symptom
time frame: Baseline(Day1),the last 24 hours post-treatment
description: TCM syndrome includes feverish, cough,intolerance of cold, headache, body ache, nasal congestion, sneezing, runny nose, pharyngeal itching.
measure: Curative effect of Traditional Chinese Medicine(TCM) syndrome
time frame: Baseline(Day1),the last 24 hours post-treatment
description: We will assess the cure rate of symptoms respectively and the total efficacy of traditional Chinese syndrome on Day 6 via the TCM syndrome scale. Cure is defined as the score of the independent symptom decreased to 0. Efficacy means the change from baseline of total score>50%.
arm group label: High dose group
arm group type: Experimental
description: High dose Susu Xiao'er Zhike Granules, 1 bag, bid
arm group label: Middle dose group
arm group type: Experimental
description: Middle dose Susu Xiao'er Zhike Granules, 1 bag, bid
arm group label: Extremely-low dose group
arm group type: Placebo Comparator
description: Extremely-low dose Susu Xiao'er Zhike Granules, 1 bag, bid
intervention type: Drug
intervention name: High dose Susu Xiao'er Zhike Granules 1 bag
description: High dose Susu Xiao'er Zhike Granules 1 bag(9g granule per bag,contains 20.25g crude herbs), twice a day (7-9a.m. and 5-7p.m.) for five days
arm group label: High dose group
intervention type: Drug
intervention name: Middle dose Susu Xiao'er Zhike Granules 1 bag
description: Middle dose Susu Xiao'er Zhike Granules 1 bag(9g granule per bag,contains 10.13g crude herbs), twice a day (7-9a.m. and 5-7p.m.) for five days
arm group label: Middle dose group
intervention type: Drug
intervention name: Extremely-low dose Susu Xiao'er Zhike Granules 1 bag
description: Extremely-low dose Susu Xiao'er Zhike Granules 1 bag(9g granule per bag,contains 0.51g crude herbs), twice a day (7-9a.m. and 5-7p.m.) for five days
arm group label: Extremely-low dose group
criteria: 
gender: All
minimum age: 6 Years
maximum age: 14 Years
healthy volunteers: No
last name: Rui Liu
phone: 022-86343626
email: liurui2@tasly.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Common Cold
mesh term: Cough