<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/NCT01686022</url>
  </required_header>
  <id_info>
    <org_study_id>NRCT_G04</org_study_id>
    <nct_id>NCT01686022</nct_id>
  </id_info>
  <brief_title>Grass Sensitisation and Allergic Rhinitis in Thai Patients</brief_title>
  <official_title>The Study of Allergens From Grass and Weed Which Are Causes of Allergic Rhinitis in Thai Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Research Council of Thailand</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mahidol University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Allergic rhinitis patients are the patients who have nasal symptoms when triggered by indoor&#xD;
      or outdoor allergens. Outdoor allergen can be divided into grass, tree, or weed. The type of&#xD;
      grass or weed are different in various part of the world. The allergens from grass and weed&#xD;
      has never been studied in Thailand. This study will find the major allergen from Bermuda&#xD;
      grass, Johnson grass, Para grass, sedge, and ragweed, which are very common in Thailand. In&#xD;
      addition, the investigators will study about the cross-reactivity among these group of&#xD;
      allergen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To find the major allergen of grass and weed, the serum of patients will be used to bind with&#xD;
      the allergen extract by immunoblot study.&#xD;
&#xD;
      The ELISA-inhibition will be used to study about cross-reactivity among various kinds of&#xD;
      grass and weed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Allergy to Grass Pollen</condition>
  <condition>Allergic Rhinitis Due to Weed Pollens</condition>
  <arm_group>
    <arm_group_label>Pollen Allergy</arm_group_label>
    <description>Pollen allergy and control will have the same intervention, ie. Skin prick test and collect serum samples.Then measure the specificIgE, immunoblot, and ELISA inhibition</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Immunoblot</intervention_name>
    <description>serum specific IgE binds to grass extract by immunoblot</description>
    <arm_group_label>Pollen Allergy</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Allergy Clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Allergic rhinitis patients age 10-50 years old&#xD;
&#xD;
          -  Control: healthy volunteer age 18-50 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic illness such as cardiovascular diseases, liver diseases&#xD;
&#xD;
          -  History of anaphylaxis&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Punchama Pacharn, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mahidol University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Siriraj Hospital</name>
      <address>
        <city>Bangkoknoi</city>
        <state>Bangkok</state>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2012</study_first_posted>
  <last_update_submitted>September 13, 2016</last_update_submitted>
  <last_update_submitted_qc>September 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mahidol University</investigator_affiliation>
    <investigator_full_name>Punchama Pacharn</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Grass</keyword>
  <keyword>Major allergen</keyword>
  <keyword>cross-reactivity</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>
  </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/NCT01686022
org study id: NRCT_G04
nct id: NCT01686022
lead sponsor: 
collaborator: 
has dmc: No
Allergic rhinitis patients are the patients who have nasal symptoms when triggered by indoor
      or outdoor allergens. Outdoor allergen can be divided into grass, tree, or weed. The type of
      grass or weed are different in various part of the world. The allergens from grass and weed
      has never been studied in Thailand. This study will find the major allergen from Bermuda
      grass, Johnson grass, Para grass, sedge, and ragweed, which are very common in Thailand. In
      addition, the investigators will study about the cross-reactivity among these group of
      allergen.
To find the major allergen of grass and weed, the serum of patients will be used to bind with
      the allergen extract by immunoblot study.

      The ELISA-inhibition will be used to study about cross-reactivity among various kinds of
      grass and weed.
arm group label: Pollen Allergy
description: Pollen allergy and control will have the same intervention, ie. Skin prick test and collect serum samples.Then measure the specificIgE, immunoblot, and ELISA inhibition
intervention type: Other
intervention name: Immunoblot
description: serum specific IgE binds to grass extract by immunoblot
arm group label: Pollen Allergy
Serum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Punchama Pacharn, MD
role: Principal Investigator
affiliation: Mahidol University
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Mahidol University
investigator full name: Punchama Pacharn
investigator title: Principal investigator
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
sharing ipd: Undecided