<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/NCT03009136</url>
  </required_header>
  <id_info>
    <org_study_id>ISEE_2015_SCRT</org_study_id>
    <nct_id>NCT03009136</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of So-Cheong-Ryong-Tang on Perennial Allergic Rhinitis</brief_title>
  <official_title>Efficacy and Safety of So-Cheong-Ryong-Tang on Perennial Allergic Rhinitis: Study Protocol for a Double-blind, Randomized, Parallel-group, Multi-center Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyung Hee University Hospital at Gangdong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kyung Hee University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pusan National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Semyung University Affiliated Oriental Medical Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>DongGuk University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kyung Hee University Hospital at Gangdong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate the short and long term efficacy and the safety of&#xD;
      SCRT treatment for PAR&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 31, 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in Total Nasal Symptom score</measure>
    <time_frame>At baseline, week 2, 4, 8, 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score</measure>
    <time_frame>At baseline, week 2, 4, 8, 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Total serum IgE level</measure>
    <time_frame>At baseline, week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in eosinophil count</measure>
    <time_frame>At baseline, week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in cytokine level</measure>
    <time_frame>At baseline, week 4</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">154</enrollment>
  <condition>Perennial Allergic Rhinitis</condition>
  <arm_group>
    <arm_group_label>SCRT group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3g, three times a day, each taken before or between meals</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>3g, three times a day, each taken before or between meals</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SCRT</intervention_name>
    <description>composed of eight herbs: Glycyrrhiza uralensis Fischer 1g Zingiber officinale Roscoe 0.5g Cinnamomum cassia Blume 0.2g, Ephedra sinica Stapf 0.5g, Pinellia ternata Breitenbach 2.67g, Paeonia lactiflora PALL 1g, Asiasarum sieboldi F. Maekawa 0.5g, Schisandra chinensis 2.67g (per 9g of granules)</description>
    <arm_group_label>SCRT group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>is made of lactose, corn starch and caramel coloring, and has appearance, shape, weight, taste, and color similar to SCRT</description>
    <arm_group_label>placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age 18-60 years&#xD;
&#xD;
          2. presence of two or more nasal symptoms (rhinorrhea, nasal congestion, nasal itching&#xD;
             and sneezing) with severity score ≥ 2 (0 = no symptom, 1 = mild symptom, 2 = moderate&#xD;
             symptom, and 3=severe symptom)&#xD;
&#xD;
          3. presence of nasal symptoms more than 2 consecutive years; and&#xD;
&#xD;
          4. positive reaction to the one or more perennial allergen in skin prick test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. treatment with nasal/oral corticosteroids within the past month; nasal cromolyn or&#xD;
             tricyclic antidepressants within the past two weeks; or nasal/oral decongestants,&#xD;
             nasal/oral antihistamines, or antileukotrienes within the past week&#xD;
&#xD;
          2. presence of rhinosinusitis (paranasal sinus X-ray demonstrating mucosal thickening, or&#xD;
             partial or complete opacification of the paranasal sinuses)&#xD;
&#xD;
          3. presence of hypertension (systolic ≥ 180 mmHg or diastolic ≥ 100 mmHg)&#xD;
&#xD;
          4. presence of abnormal liver function (aspartate transaminase (AST) or alanine&#xD;
             transaminase (ALT) ≥ 100 IU/L) or abnormal renal function (blood urea nitrogen (BUN) ≥&#xD;
             30 mg/dL or creatinine ≥ 1.8 mg/dL (male), 1.5 mg/dL (female))&#xD;
&#xD;
          5. presence of neoplasm, severe systemic inflammation, other systemic disease that&#xD;
             affects rhinitis&#xD;
&#xD;
          6. history of drug allergy&#xD;
&#xD;
          7. history of anaphylaxis for allergic tests&#xD;
&#xD;
          8. pregnancy or lactation&#xD;
&#xD;
          9. participation of other clinical study within the past 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Minhee Kim</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kyung Hee University Hospital at Gangdong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Youme Ko</last_name>
    <phone>822-961-9278</phone>
    <email>iseeymk@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kyung Hee University Hospital at Gangdong</name>
      <address>
        <city>Seoul</city>
        <zip>05278</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Youme Ko, MD(TCM)</last_name>
      <phone>82-2-961-9278</phone>
      <email>meyougo@khu.ac.kr</email>
    </contact>
    <investigator>
      <last_name>Minhee Kim</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>March 12, 2017</last_update_submitted>
  <last_update_submitted_qc>March 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kyung Hee University Hospital at Gangdong</investigator_affiliation>
    <investigator_full_name>Minhee Kim</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Perennial Allergic Rhinitis</keyword>
  <keyword>Herbal Medicine</keyword>
  <keyword>Korean Medicine</keyword>
  <keyword>So-Cheong-Ryong-Tang</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rhinitis</mesh_term>
    <mesh_term>Rhinitis, Allergic</mesh_term>
    <mesh_term>Rhinitis, Allergic, Perennial</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03009136
org study id: ISEE_2015_SCRT
nct id: NCT03009136
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The aim of this study is to investigate the short and long term efficacy and the safety of
      SCRT treatment for PAR
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Change from baseline in Total Nasal Symptom score
time frame: At baseline, week 2, 4, 8, 12
measure: Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score
time frame: At baseline, week 2, 4, 8, 12
measure: Change from baseline in Total serum IgE level
time frame: At baseline, week 4
measure: Change from baseline in eosinophil count
time frame: At baseline, week 4
measure: Change from baseline in cytokine level
time frame: At baseline, week 4
arm group label: SCRT group
arm group type: Experimental
description: 3g, three times a day, each taken before or between meals
arm group label: placebo group
arm group type: Placebo Comparator
description: 3g, three times a day, each taken before or between meals
intervention type: Drug
intervention name: SCRT
description: composed of eight herbs: Glycyrrhiza uralensis Fischer 1g Zingiber officinale Roscoe 0.5g Cinnamomum cassia Blume 0.2g, Ephedra sinica Stapf 0.5g, Pinellia ternata Breitenbach 2.67g, Paeonia lactiflora PALL 1g, Asiasarum sieboldi F. Maekawa 0.5g, Schisandra chinensis 2.67g (per 9g of granules)
arm group label: SCRT group
intervention type: Drug
intervention name: Placebos
description: is made of lactose, corn starch and caramel coloring, and has appearance, shape, weight, taste, and color similar to SCRT
arm group label: placebo group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Minhee Kim
role: Principal Investigator
affiliation: Kyung Hee University Hospital at Gangdong
last name: Youme Ko
phone: 822-961-9278
email: iseeymk@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Kyung Hee University Hospital at Gangdong
investigator full name: Minhee Kim
investigator title: Clinical Professor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
mesh term: Rhinitis, Allergic, Perennial
sharing ipd: Undecided