<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/NCT02208414</url>
  </required_header>
  <id_info>
    <org_study_id>201111069RID</org_study_id>
    <nct_id>NCT02208414</nct_id>
  </id_info>
  <brief_title>Randomized Double-Blind Placebo-Controlled Crab or Shrimp Allergy Reduction Study Using Nambudripad Allergy Elimination Techniques</brief_title>
  <official_title>A Randomized Double-Blind Placebo-Controlled Crab Allergy Reduction Study Using Nambudripad Allergy Elimination Techniques in NTU Campus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose of this study is to determine whether NAET procedures are effective in the treatment&#xD;
      of crab or shrimp allergy.&#xD;
&#xD;
      Hypothesis: experimental group will show a significant improvement over the control group in&#xD;
      allergic symptom, serum crab- or shrimp-specific IgE and skin test for crab or shrimp&#xD;
      extract.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nambudripad allergy elimination techniques (NAET) were developed by Dr. Devi Nambudripad in&#xD;
      1983. Many patients have been relieved of allergy and allergy-related disease by this&#xD;
      treatment.&#xD;
&#xD;
      Lack of well-controlled clinical study prevents NAET from being accepted as a treatment&#xD;
      option in current medical system.&#xD;
&#xD;
      The aim of this project is to conduct a double blind-placebo controlled study of applying&#xD;
      NAET to treat crab or shrimp allergy.&#xD;
&#xD;
      The parameters to be measured are allergic symptom, crab- or shrimp-specific IgE and skin&#xD;
      test before and after NAET treatment&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>June 2012</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>N/A</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in allergic symptoms at 6 months</measure>
    <time_frame>before NAET and 6 months after NAET</time_frame>
    <description>Symptoms when exposed to crab or shrimp which include symptoms of skin, eye, respiratory tract, gastrointestinal tract, cardiovascular system and others. The participants give score subjectively from 0 to 10 according to the severity of the symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum crab- or shrimp-specific IgE</measure>
    <time_frame>before NAET, 1 month, 3 months and 6 months after NAET</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin test</measure>
    <time_frame>before NAET, 1 month and 6 months after NAET</time_frame>
    <description>Skin test for crab or shrimp extract</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Food Allergies</condition>
  <arm_group>
    <arm_group_label>Crab or shrimp</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: treated with crab and shrimp energy signature vial using NAET</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Treated with water vial</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>NAET</intervention_name>
    <description>NAET with acupressure and/or chiropractic procedures with the participant holding crab and shrimp energy signature vial</description>
    <arm_group_label>Crab or shrimp</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>NAET</intervention_name>
    <description>NAET with acupressure and/or chiropractic procedures with the participant holding water vial</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Older or equal to 20 years old&#xD;
&#xD;
          -  History of allergic to crab or shrimp&#xD;
&#xD;
          -  Positive serum crab- or shrimp-specific IgE&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of anaphylactic shock&#xD;
&#xD;
          -  On medication of anti-histamine or steroid&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cha Ze Lee, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>January 2, 2013</study_first_submitted>
  <study_first_submitted_qc>August 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>August 3, 2014</last_update_submitted>
  <last_update_submitted_qc>August 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Food Allergies</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Food Hypersensitivity</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/NCT02208414
org study id: 201111069RID
nct id: NCT02208414
lead sponsor: 
has dmc: Yes
Purpose of this study is to determine whether NAET procedures are effective in the treatment
      of crab or shrimp allergy.

      Hypothesis: experimental group will show a significant improvement over the control group in
      allergic symptom, serum crab- or shrimp-specific IgE and skin test for crab or shrimp
      extract.
Nambudripad allergy elimination techniques (NAET) were developed by Dr. Devi Nambudripad in
      1983. Many patients have been relieved of allergy and allergy-related disease by this
      treatment.

      Lack of well-controlled clinical study prevents NAET from being accepted as a treatment
      option in current medical system.

      The aim of this project is to conduct a double blind-placebo controlled study of applying
      NAET to treat crab or shrimp allergy.

      The parameters to be measured are allergic symptom, crab- or shrimp-specific IgE and skin
      test before and after NAET treatment
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change from Baseline in allergic symptoms at 6 months
time frame: before NAET and 6 months after NAET
description: Symptoms when exposed to crab or shrimp which include symptoms of skin, eye, respiratory tract, gastrointestinal tract, cardiovascular system and others. The participants give score subjectively from 0 to 10 according to the severity of the symptoms.
measure: Serum crab- or shrimp-specific IgE
time frame: before NAET, 1 month, 3 months and 6 months after NAET
measure: Skin test
time frame: before NAET, 1 month and 6 months after NAET
description: Skin test for crab or shrimp extract
arm group label: Crab or shrimp
arm group type: Experimental
description: Intervention: treated with crab and shrimp energy signature vial using NAET
arm group label: Placebo
arm group type: Placebo Comparator
description: Treated with water vial
intervention type: Procedure
intervention name: NAET
description: NAET with acupressure and/or chiropractic procedures with the participant holding crab and shrimp energy signature vial
arm group label: Crab or shrimp
intervention type: Procedure
intervention name: NAET
description: NAET with acupressure and/or chiropractic procedures with the participant holding water vial
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Cha Ze Lee, MD, PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Hypersensitivity
mesh term: Food Hypersensitivity