<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/NCT04419584</url>
  </required_header>
  <id_info>
    <org_study_id>AD study</org_study_id>
    <nct_id>NCT04419584</nct_id>
  </id_info>
  <brief_title>Evaluate the Efficacy of Using Modified Qing-Ying Decoction in Atopic Dermatitis Children</brief_title>
  <official_title>A Randomized Placebo-Controlled Clinical Trial of an Innovative Herbal Formula for Atopic Dermatitis in Children: Evaluations of Modified Qing-Ying Decoction on Efficacy and Gut Microbiome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</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>
      The study aims to evaluate the clinical efficacy and safety of the modified Qing-Ying&#xD;
      Decoction (mQYD) for the treatment of subacute and chronic atopic dermatitis (AD) in children&#xD;
      when compared to the placebo control through examining the clinical symptoms, quality of&#xD;
      life, gut microbiome, and Chinese medicine body constitution.&#xD;
&#xD;
      This is a parallel, randomized, placebo-controlled, double-blind clinical trial. Eligible&#xD;
      subjects will be randomly allocated to receive oral mQYD granules or it's placebo granules.&#xD;
      Subjects will have 12-week of treatment, and then a 4-week follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The subjects will come for a screening visit at week 0 (baseline), then at week 6, week 12,&#xD;
      and week 16 for Chinese medicine practitioner (CMP) investigators assessments. Eczema Area&#xD;
      and Severity Index (EASI), Children's Dermatology Life Quality Index (CDLQI),&#xD;
      Patient-Oriented Eczema Measure (POEM), and Chinese Medicine body constitution types will be&#xD;
      assessed and filled up at different timepoints. They will receive oral herbal mQYD or placebo&#xD;
      granules for 12 weeks and then be followed up 4 weeks after the treatment. Registered CMPs&#xD;
      will provide consultation under Chinese medicine theory. Study medication compliance and&#xD;
      adverse events will also be assessed at each visit. Besides, they need to record the food&#xD;
      taken in a diary before the day for taking faecal specimen for gut microbiome analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 10, 2020</start_date>
  <completion_date type="Anticipated">May 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Eczema Area and Severity Index (EASI)</measure>
    <time_frame>16 weeks</time_frame>
    <description>Min value: 0, max value: 72, higher scores mean worse outcome. To assess the severity of atopic dermatitis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Oriented Eczema Measure (POEM)</measure>
    <time_frame>16 weeks</time_frame>
    <description>Min value: 0, max value: 28, higher scores mean worse outcome. To assess the subjective symptoms of subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Children's Dermatology Life Quality Index (CDLQI)</measure>
    <time_frame>16 weeks</time_frame>
    <description>Min value: 0, max value: 30, higher scores mean worse outcome. To assess the quality of life of subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Constitution of Chinese Medicine Questionnaire (CCMQ)</measure>
    <time_frame>16 weeks</time_frame>
    <description>Not a scale. Based on the answers, a logarithm will be used to determine the type of Chinese Medicine Constitution of the subjects. To assess the Chinese medicine body constitution of subjects.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">64</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Modified Qing-Ying Decoction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Herbal granules, twice per day for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Identical looking placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo granules, twice per day for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Modified Qing-Ying Decoction</intervention_name>
    <description>Herbal granules</description>
    <arm_group_label>Modified Qing-Ying Decoction</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Identical looking placebo</intervention_name>
    <description>Placebo granules</description>
    <arm_group_label>Identical looking placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age of 4 to 17 (Chinese only);&#xD;
&#xD;
          2. With EASI ≥ 10;&#xD;
&#xD;
          3. Subacute and chronic atopic dermatitis presenting with dry, scaly, erythematous&#xD;
             papules and plaques; and&#xD;
&#xD;
          4. Provide written informed consent form (signed by one of their parents)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of allergy to Chinese medicines;&#xD;
&#xD;
          2. AD with Yang deficiency in syndrome differentiation, such as pale looking, always&#xD;
             feeling cold, fatigue, chronic diarrhea with loose stool, urinary disorders such as&#xD;
             urinary difficulty, excessive urination or incontinence&#xD;
&#xD;
          3. Known overt bacterial infections in the skin;&#xD;
&#xD;
          4. Known pregnancy;&#xD;
&#xD;
          5. Known severe medical conditions, such as cardiovascular, liver or renal dysfunction or&#xD;
             Diabetes Mellitus;&#xD;
&#xD;
          6. Having used oral corticosteroids, oral antibiotics, other immunosuppressive or any&#xD;
             preparation of oral herbal medicines for the treatment of AD in the past month;&#xD;
&#xD;
          7. Having been diagnosed with scabies, allergic contact dermatitis, seborrheic dermatitis&#xD;
             or psoriasis; and&#xD;
&#xD;
          8. Has taken anti-coagulant or anti-platelet drugs in the past month.&#xD;
&#xD;
          9. Has taken any probiotics, prebiotics in the last month&#xD;
&#xD;
         10. Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhi-xiu Lin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Chinese University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 21, 2022</last_update_submitted>
  <last_update_submitted_qc>June 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Prof. Lin Zhixiu</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04419584
org study id: AD study
nct id: NCT04419584
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study aims to evaluate the clinical efficacy and safety of the modified Qing-Ying
      Decoction (mQYD) for the treatment of subacute and chronic atopic dermatitis (AD) in children
      when compared to the placebo control through examining the clinical symptoms, quality of
      life, gut microbiome, and Chinese medicine body constitution.

      This is a parallel, randomized, placebo-controlled, double-blind clinical trial. Eligible
      subjects will be randomly allocated to receive oral mQYD granules or it's placebo granules.
      Subjects will have 12-week of treatment, and then a 4-week follow-up.
The subjects will come for a screening visit at week 0 (baseline), then at week 6, week 12,
      and week 16 for Chinese medicine practitioner (CMP) investigators assessments. Eczema Area
      and Severity Index (EASI), Children's Dermatology Life Quality Index (CDLQI),
      Patient-Oriented Eczema Measure (POEM), and Chinese Medicine body constitution types will be
      assessed and filled up at different timepoints. They will receive oral herbal mQYD or placebo
      granules for 12 weeks and then be followed up 4 weeks after the treatment. Registered CMPs
      will provide consultation under Chinese medicine theory. Study medication compliance and
      adverse events will also be assessed at each visit. Besides, they need to record the food
      taken in a diary before the day for taking faecal specimen for gut microbiome analysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Eczema Area and Severity Index (EASI)
time frame: 16 weeks
description: Min value: 0, max value: 72, higher scores mean worse outcome. To assess the severity of atopic dermatitis
measure: Patient Oriented Eczema Measure (POEM)
time frame: 16 weeks
description: Min value: 0, max value: 28, higher scores mean worse outcome. To assess the subjective symptoms of subjects.
measure: Children's Dermatology Life Quality Index (CDLQI)
time frame: 16 weeks
description: Min value: 0, max value: 30, higher scores mean worse outcome. To assess the quality of life of subjects.
measure: Constitution of Chinese Medicine Questionnaire (CCMQ)
time frame: 16 weeks
description: Not a scale. Based on the answers, a logarithm will be used to determine the type of Chinese Medicine Constitution of the subjects. To assess the Chinese medicine body constitution of subjects.
arm group label: Modified Qing-Ying Decoction
arm group type: Experimental
description: Herbal granules, twice per day for 12 weeks
arm group label: Identical looking placebo
arm group type: Placebo Comparator
description: Placebo granules, twice per day for 12 weeks
intervention type: Drug
intervention name: Modified Qing-Ying Decoction
description: Herbal granules
arm group label: Modified Qing-Ying Decoction
intervention type: Drug
intervention name: Identical looking placebo
description: Placebo granules
arm group label: Identical looking placebo
criteria: 
gender: All
minimum age: 4 Years
maximum age: 17 Years
healthy volunteers: No
last name: Zhi-xiu Lin, PhD
role: Principal Investigator
affiliation: Chinese University of Hong Kong
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Prof. Lin Zhixiu
investigator title: Associate professor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
sharing ipd: No