<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/NCT02191046</url>
  </required_header>
  <id_info>
    <org_study_id>ทป 45/2555</org_study_id>
    <secondary_id>45/2555</secondary_id>
    <nct_id>NCT02191046</nct_id>
  </id_info>
  <brief_title>Effect of Squeezable Bottle Nasal Irrigation Device in Children With Sinusitis</brief_title>
  <official_title>A Randomized- Controlled Study Comparing the Effect of Squeezable Bottle Nasal Irrigation Device With Syringe in Children With Sinusitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thammasat University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Thammasat University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to the effect of squeezable bottle nasal irrigation device with&#xD;
      syringe in children with sinusitis in symptom score and satisfaction to nasal irrigation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      sinusitis is the one of common diseases in Thailand. Nasal irrigation has been used as an&#xD;
      adjunctive treatment.In previous study shown that buffer hypertonic nasal irrigation have&#xD;
      more effective to decrease symptom in patient sinonasal disease when compare to normal&#xD;
      saline.Until now, there are no clear data comparing the effectiveness on sinonasal symptom of&#xD;
      the various devices use in children with sinusitis. The purpose of this study was to compare&#xD;
      the effect of squeezable bottle nasal irrigation device with syringe in children with&#xD;
      sinusitis in symptom score and satisfaction to nasal irrigation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children</measure>
    <time_frame>compare 5S-score of both group at 2 week and at baseline visit .compare the mean 5S-score and satisfaction score between both group at 2 weeks after treatment</time_frame>
    <description>For 5S-score, we measured the the mean 5-s score of both group at 2 weeks compare to the mean 5-s score at baseline visit and compare 5S-score between group at 2 weeks. The S5- score is a scale assessing severity of sinusitis. It compose of the symptom scores for nasal obstruction, day and nighttime cough, headache and nasal discharge. All symptom were graded from 0(no symptom) to 3 (severe ).The score were summed to give the mean 5S-score.It range from 0 (best possible outcome) to 15(worst possible outcome). 7-point Likert scale for satisfaction score is scale from 1 (indicating unsatisfactory) to 7 (indicating excellent). For satisfaction, we reported the result in the term of 7 points Likert scale and compare these scale between group at 2 weeks after treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the Contamination in Nasal Irrigation Devices</measure>
    <time_frame>at second week after treatment</time_frame>
    <description>compare the result of bacterial culture in both group of nasal irrigation devices. We reported in the following item; no growth, gram positive or gram negative or mixed organism</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Sinusitis</condition>
  <arm_group>
    <arm_group_label>syringe 20 ml</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>nasal irrigation with syringe by using buffer hypertonic saline about 100-240 ml until no nasal discharge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>squeezable bottle</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>nasal irrigation with squeezable bottle by using buffer hypertonic saline about 100-240 ml until no nasal discharge</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>squeezable bottle</intervention_name>
    <description>nasal irrigation twice daily for 2 weeks period</description>
    <arm_group_label>squeezable bottle</arm_group_label>
    <other_name>EEZNIS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>syringe 20 ml</intervention_name>
    <description>nasal irrigation twice daily for 2 weeks</description>
    <arm_group_label>syringe 20 ml</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age 3-15 years&#xD;
&#xD;
          2. diagnose sinusitis by each of following criteria 2.1 persistent upper respiratory&#xD;
             infection symptoms &gt; or = 10 days 2.2. severe upper respiratory infection symptom with&#xD;
             greenish discharge per nose or periorbital swelling 2.3 double sickening of upper&#xD;
             respiratory infection symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. patient who has history of penicillin allergy&#xD;
&#xD;
          2. patient who has complication of sinusitis&#xD;
&#xD;
          3. patient with a history of nasal anatomical defects&#xD;
&#xD;
          4. patient who has immune deficiency or primary ciliary dyskinesia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Araya Satdhabudha, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thammasat University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Araya Satdhabudha</name>
      <address>
        <city>Klongluang</city>
        <state>Pratumthanee</state>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>July 13, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <results_first_submitted>July 15, 2014</results_first_submitted>
  <results_first_submitted_qc>October 31, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 4, 2014</results_first_posted>
  <last_update_submitted>October 31, 2014</last_update_submitted>
  <last_update_submitted_qc>October 31, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 4, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Thammasat University</investigator_affiliation>
    <investigator_full_name>araya satdhabudha</investigator_full_name>
    <investigator_title>clinical professor</investigator_title>
  </responsible_party>
  <keyword>nasal irrigation</keyword>
  <keyword>sinusitis</keyword>
  <keyword>children</keyword>
  <keyword>buffered hypertonic saline</keyword>
  <keyword>nasal irrigation device</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sinusitis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>we enrolled sinusitis patient age 3-15 year during March 2013 - May 2014. We excluded patients with a history of penicillin allergy, nasal anatomic defects, immunodeficiency or had complication from sinusitis. Patient with low compliance defined as the rate usage nasal irrigation estimated at less than 80% were excluded</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Syringe 20 ml</title>
          <description>nasal irrigation with syringe by using buffer hypertonic saline about 100-240 ml until no nasal discharge&#xD;
syringe 20 ml: nasal irrigation twice daily for 2 weeks period</description>
        </group>
        <group group_id="P2">
          <title>Squeezable Bottle</title>
          <description>nasal irrigation with squeezable bottle by using buffer hypertonic saline about 100-240 ml until no nasal discharge&#xD;
squeezable bottle: nasal irrigation twice daily for 2 weeks period</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36">exclude 5 patients because low compliance</participants>
                <participants group_id="P2" count="38">exclude 1 patient because low compliance</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>low compliance</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Eighty sinusitis children participated in the study. 74 participants were finally assessed. six participants were discontinue irrigated their nose during treatment due to the nasal symptoms score improve; one patient from squeezable bottle group, five patients from disposable syringe group.</population>
      <group_list>
        <group group_id="B1">
          <title>Syringe 20 ml</title>
          <description>nasal irrigation with syringe by using buffer hypertonic saline about 100-240 ml until no nasal discharge&#xD;
syringe 20 ml: nasal irrigation twice daily for 2 weeks period</description>
        </group>
        <group group_id="B2">
          <title>Squeezable Bottle</title>
          <description>nasal irrigation with squeezable bottle by using buffer hypertonic saline about 100-240 ml until no nasal discharge&#xD;
squeezable bottle: nasal irrigation twice daily for 2 weeks period</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="36"/>
            <count group_id="B2" value="38"/>
            <count group_id="B3" value="74"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Thailand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children</title>
        <description>For 5S-score, we measured the the mean 5-s score of both group at 2 weeks compare to the mean 5-s score at baseline visit and compare 5S-score between group at 2 weeks. The S5- score is a scale assessing severity of sinusitis. It compose of the symptom scores for nasal obstruction, day and nighttime cough, headache and nasal discharge. All symptom were graded from 0(no symptom) to 3 (severe ).The score were summed to give the mean 5S-score.It range from 0 (best possible outcome) to 15(worst possible outcome). 7-point Likert scale for satisfaction score is scale from 1 (indicating unsatisfactory) to 7 (indicating excellent). For satisfaction, we reported the result in the term of 7 points Likert scale and compare these scale between group at 2 weeks after treatment</description>
        <time_frame>compare 5S-score of both group at 2 week and at baseline visit .compare the mean 5S-score and satisfaction score between both group at 2 weeks after treatment</time_frame>
        <population>The S5- score is the symptom scores for nasal obstruction, day and nighttime cough, headache and nasal discharge. All symptom were graded from 0(no symptom) to 3 (severe ).The score were summed to give the mean 5S-score.7-point Likert scale for satisfaction score is scale from 1 (indicating unsatisfactory) to 7 (indicating excellent).</population>
        <group_list>
          <group group_id="O1">
            <title>Syringe 20 ml</title>
            <description>improve 5-s score at 2 week period after treatment when compare to the beginning status with minimal side effect</description>
          </group>
          <group group_id="O2">
            <title>Squeezable Bottle</title>
            <description>improve 5-s score at 2 week period after treatment when compare to the beginning status with minimal side effect and significant improve in 5-s score and satisfaction when compare to syringe group</description>
          </group>
        </group_list>
        <measure>
          <title>the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children</title>
          <description>For 5S-score, we measured the the mean 5-s score of both group at 2 weeks compare to the mean 5-s score at baseline visit and compare 5S-score between group at 2 weeks. The S5- score is a scale assessing severity of sinusitis. It compose of the symptom scores for nasal obstruction, day and nighttime cough, headache and nasal discharge. All symptom were graded from 0(no symptom) to 3 (severe ).The score were summed to give the mean 5S-score.It range from 0 (best possible outcome) to 15(worst possible outcome). 7-point Likert scale for satisfaction score is scale from 1 (indicating unsatisfactory) to 7 (indicating excellent). For satisfaction, we reported the result in the term of 7 points Likert scale and compare these scale between group at 2 weeks after treatment</description>
          <population>The S5- score is the symptom scores for nasal obstruction, day and nighttime cough, headache and nasal discharge. All symptom were graded from 0(no symptom) to 3 (severe ).The score were summed to give the mean 5S-score.7-point Likert scale for satisfaction score is scale from 1 (indicating unsatisfactory) to 7 (indicating excellent).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>5S-score at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.56" spread="2.35"/>
                    <measurement group_id="O2" value="6.89" spread="2.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5S-score at 2 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.17" spread="2.03"/>
                    <measurement group_id="O2" value="1.24" spread="1.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>satisfaction score at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.11" spread="1.19"/>
                    <measurement group_id="O2" value="5.97" spread="1.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>satisfaction score at 2 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.11" spread="0.85"/>
                    <measurement group_id="O2" value="6.57" spread="0.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>compare the mean 5S-score between before and after treatment in syringe group</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>power of study = 90%</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>4.38</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>2.89</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.41</ci_lower_limit>
            <ci_upper_limit>5.37</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>compare the mean 5S-score between 2 groups at 2 weeks after treatment</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>power of study = 90%</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.93</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.42</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.094</ci_lower_limit>
            <ci_upper_limit>1.76</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>satisfaction score between two groups at 2 weeks after treatment</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>power of study = 90%</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.47</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.17</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.82</ci_lower_limit>
            <ci_upper_limit>-0.12</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>compare the mean 5s-score between before and after treatment in squeezable bottle group</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>power fo study = 90%</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>5.66</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>3.16</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.62</ci_lower_limit>
            <ci_upper_limit>6.69</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>the Contamination in Nasal Irrigation Devices</title>
        <description>compare the result of bacterial culture in both group of nasal irrigation devices. We reported in the following item; no growth, gram positive or gram negative or mixed organism</description>
        <time_frame>at second week after treatment</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>we monitor side effect from the beginning of treatment until 2 weeks after treatment</time_frame>
      <desc>we monitor side effect from the beginning of treatment until 2 weeks after treatment. the physician asking the symptoms after nasal irrigation at baseline visit then the symptoms were recorded daily by parents and noted in diary card</desc>
      <group_list>
        <group group_id="E1">
          <title>Syringe 20 ml</title>
          <description>record adverse event at baseline and daily adverse events until 2 weeks after treatment</description>
        </group>
        <group group_id="E2">
          <title>Squeezable Bottle</title>
          <description>record adverse event at baseline and daily adverse events until 2 weeks after treatment</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>tinnitus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>nasal irritation</sub_title>
                <counts group_id="E1" events="10" subjects_affected="6" subjects_at_risk="36"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>nasal congestion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr.Araya Satdhabudha</name_or_title>
      <organization>Thammasat university</organization>
      <phone>0813414900 ext 662</phone>
      <email>araya221@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02191046
org study id: ทป 45/2555
secondary id: 45/2555
nct id: NCT02191046
lead sponsor: 
has dmc: No
The purpose of this study is to the effect of squeezable bottle nasal irrigation device with
      syringe in children with sinusitis in symptom score and satisfaction to nasal irrigation
sinusitis is the one of common diseases in Thailand. Nasal irrigation has been used as an
      adjunctive treatment.In previous study shown that buffer hypertonic nasal irrigation have
      more effective to decrease symptom in patient sinonasal disease when compare to normal
      saline.Until now, there are no clear data comparing the effectiveness on sinonasal symptom of
      the various devices use in children with sinusitis. The purpose of this study was to compare
      the effect of squeezable bottle nasal irrigation device with syringe in children with
      sinusitis in symptom score and satisfaction to nasal irrigation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children
time frame: compare 5S-score of both group at 2 week and at baseline visit .compare the mean 5S-score and satisfaction score between both group at 2 weeks after treatment
description: For 5S-score, we measured the the mean 5-s score of both group at 2 weeks compare to the mean 5-s score at baseline visit and compare 5S-score between group at 2 weeks. The S5- score is a scale assessing severity of sinusitis. It compose of the symptom scores for nasal obstruction, day and nighttime cough, headache and nasal discharge. All symptom were graded from 0(no symptom) to 3 (severe ).The score were summed to give the mean 5S-score.It range from 0 (best possible outcome) to 15(worst possible outcome). 7-point Likert scale for satisfaction score is scale from 1 (indicating unsatisfactory) to 7 (indicating excellent). For satisfaction, we reported the result in the term of 7 points Likert scale and compare these scale between group at 2 weeks after treatment
measure: the Contamination in Nasal Irrigation Devices
time frame: at second week after treatment
description: compare the result of bacterial culture in both group of nasal irrigation devices. We reported in the following item; no growth, gram positive or gram negative or mixed organism
arm group label: syringe 20 ml
arm group type: Active Comparator
description: nasal irrigation with syringe by using buffer hypertonic saline about 100-240 ml until no nasal discharge
arm group label: squeezable bottle
arm group type: Experimental
description: nasal irrigation with squeezable bottle by using buffer hypertonic saline about 100-240 ml until no nasal discharge
intervention type: Device
intervention name: squeezable bottle
description: nasal irrigation twice daily for 2 weeks period
arm group label: squeezable bottle
other name: EEZNIS
intervention type: Device
intervention name: syringe 20 ml
description: nasal irrigation twice daily for 2 weeks
arm group label: syringe 20 ml
criteria: 
gender: All
minimum age: 3 Years
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Araya Satdhabudha, MD
role: Principal Investigator
affiliation: Thammasat University
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Thammasat University
investigator full name: araya satdhabudha
investigator title: clinical professor
mesh term: Sinusitis
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 