<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/NCT02225912</url>
  </required_header>
  <id_info>
    <org_study_id>Previn-C</org_study_id>
    <nct_id>NCT02225912</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy of the Nasal Antiseptic, PrevinC, When Administered for the RiskReduction of Rhinitis in Subjects Who Work for Child Day Care Centers</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioHealth Technologies Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BioHealth Technologies Inc.</source>
  <brief_summary>
    <textblock>
      The hypothesis was to establish whether the use of PrevinC administered nasally 2-3 times a&#xD;
      day will prevent upper respiratory infections in otherwise healthy adults working in child&#xD;
      day care centers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2005</start_date>
  <completion_date type="Actual">May 2005</completion_date>
  <primary_completion_date type="Actual">May 2005</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Crossover Assignment</intervention_model>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rhinitis</measure>
    <time_frame>weekly from February 2005 to May 2005, up to 3 months</time_frame>
    <description>The incidence of rhinitis was measured on a weekly basis through evaluation of study diaries.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <condition>Upper Respiratory Infections</condition>
  <arm_group>
    <arm_group_label>PrevinC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PrevinC contains isopropyl alcohol, sesame oil, aloe vera oil extract, and lemon oil.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control solution</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The control solution (distilled water and lemon oil) was similar in color, oily consistency and odor to that of PrevinC.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PrevinC</intervention_name>
    <arm_group_label>PrevinC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>Control solution</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must provide written informed consent prior to the conduct of any study&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  18-65 years of age&#xD;
&#xD;
          -  Inclusive&#xD;
&#xD;
          -  Employed by one of seven selected Day Care Centers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recent symptoms of upper respiratory infection, respiratory disease&#xD;
&#xD;
          -  Received medication for colds or allergies within 3 weeks of enrolling&#xD;
&#xD;
          -  Had nasal surgery within 2 months of enrolling&#xD;
&#xD;
          -  Had a pierced nose or wore nose jewelry&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Sunflower Preschool &amp; Day Care</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mt Sinai Day Care</name>
      <address>
        <city>Miami Beach</city>
        <state>Florida</state>
        <zip>33141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunflower Preschool Childcare</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunflowers Academy</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunflowers Academy</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunflowers Preschool Childcare</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 23, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>January 15, 2019</last_update_submitted>
  <last_update_submitted_qc>January 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Tract Infections</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/NCT02225912
org study id: Previn-C
nct id: NCT02225912
lead sponsor: 
The hypothesis was to establish whether the use of PrevinC administered nasally 2-3 times a
      day will prevent upper respiratory infections in otherwise healthy adults working in child
      day care centers.
intervention model: Crossover Assignment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Rhinitis
time frame: weekly from February 2005 to May 2005, up to 3 months
description: The incidence of rhinitis was measured on a weekly basis through evaluation of study diaries.
arm group label: PrevinC
arm group type: Experimental
description: PrevinC contains isopropyl alcohol, sesame oil, aloe vera oil extract, and lemon oil.
arm group label: Control solution
arm group type: Placebo Comparator
description: The control solution (distilled water and lemon oil) was similar in color, oily consistency and odor to that of PrevinC.
intervention type: Other
intervention name: PrevinC
arm group label: PrevinC
intervention type: Drug
intervention name: placebo
arm group label: Control solution
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Respiratory Tract Infections