<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/NCT03755596</url>
  </required_header>
  <id_info>
    <org_study_id>ZOTC 01-05-18</org_study_id>
    <nct_id>NCT03755596</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of the Use of Ginger Extract in the Management of Motion Sickness</brief_title>
  <official_title>Clinical Evaluation of the Use of Ginger Extract in the Management of Motion Sickness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundação Educacional Serra dos Órgãos</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Melora do Brasil Produtos Dermatológicos S/A</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundação Educacional Serra dos Órgãos</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, case control study of 180 patients presenting motion sickness, who&#xD;
      will perform a motion sickness assessment questionnaire before and after treatment with dry&#xD;
      ginger (Z. officinale) extract.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This open-label, self-paired, case-control study will evaluate 180 patients presenting motion&#xD;
      sickness. The primary study objective is to evaluate the use of dry Z. officinale extract&#xD;
      160mg (containing 8mg gingerol) in the treatment of patients presenting motion sickness. The&#xD;
      secondary objectives are to evaluate the effect of the treatment on the scores and subscores&#xD;
      of the Motion Sickness Assessment Questionnaire (MSAQ) before and after treatment, as well as&#xD;
      to assess treatment tolerability in this population. The total study duration will be seven&#xD;
      days. A total of four specific motion sickness assessments will be performed, one&#xD;
      pre-treatment and three during the treatment period, which consists of an oral dose of 160mg&#xD;
      ginger extract 30 minutes prior to the trip under evaluation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Open-label, single-group, self-paired study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MSAQ total score change at Assessment 2</measure>
    <time_frame>MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.</time_frame>
    <description>Percentage of patients presenting change of 20 or more points on total MSAQ scores at Assessment 2 in relation to pretreatment scores.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MSAQ total score change at Assessment 3</measure>
    <time_frame>MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.</time_frame>
    <description>Percentage of patients presenting change of 20 or more points on total MSAQ scores at Assessment 3 in relation to pretreatment scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MSAQ total score change at Assessment 4</measure>
    <time_frame>MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.</time_frame>
    <description>Percentage of patients presenting change of 20 or more points on total MSAQ scores at Assessment 4 in relation to pretreatment scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MSAQ subscore change at Assessment 2</measure>
    <time_frame>MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.</time_frame>
    <description>Percentage of patients presenting change on MSAQ subscores at Assessment 2 in relation to pretreatment scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MSAQ subscore change at Assessment 3</measure>
    <time_frame>MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.</time_frame>
    <description>Percentage of patients presenting change on MSAQ subscores at Assessment 3 in relation to pretreatment scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MSAQ subscore change at Assessment 4</measure>
    <time_frame>MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.</time_frame>
    <description>Percentage of patients presenting change on MSAQ subscores at Assessment 4 in relation to pretreatment scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse event occurrence</measure>
    <time_frame>From first dose to end of study (no more than 7 days from Pretreatment visit date)</time_frame>
    <description>Number of subjects reporting adverse effects during treatment period</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Physician Assessment score change</measure>
    <time_frame>Scores taken at pretreatment and at the end of the treatment period (no more than 7 days).</time_frame>
    <description>Mean Physician Assessment (10-point scale assessing overall patient condition ranging from 1 [worst] to 10 [best]) score improvement at end-of-study visit compared to pretreatment scores.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">184</enrollment>
  <condition>Motion Sickness</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral treatment with single-dose 160mg Z. officinale extract in tablet form.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Z. officinale extract</intervention_name>
    <description>Oral dose of 160mg dry ginger root (Z. officinale) extract in tablet form.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of both sexes between the ages of 18 and 65&#xD;
&#xD;
          -  Clinical presentation of motion sickness&#xD;
&#xD;
          -  Female participant of reproductive age agrees to use birth control during study period&#xD;
&#xD;
          -  Patient has read, understood, signed and dated informed consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypersensitivity to any component of the study drug&#xD;
&#xD;
          -  History of biliary calculus&#xD;
&#xD;
          -  History of gastric irritation&#xD;
&#xD;
          -  Hypertension &gt; 145 / 100mmHg&#xD;
&#xD;
          -  Concomitant use of other medicinal products for the treatment of motion sickness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centro Universitário Serra dos Órgãos - UNIFESO</name>
      <address>
        <city>Teresópolis</city>
        <state>RJ</state>
        <zip>25964004</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>September 24, 2019</last_update_submitted>
  <last_update_submitted_qc>September 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundação Educacional Serra dos Órgãos</investigator_affiliation>
    <investigator_full_name>Carlos Pereira Nunes</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Zingiber officinale</keyword>
  <keyword>Motion sickness</keyword>
  <keyword>Motion sickness assessment questionnaire</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Motion Sickness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03755596
org study id: ZOTC 01-05-18
nct id: NCT03755596
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is an open-label, case control study of 180 patients presenting motion sickness, who
      will perform a motion sickness assessment questionnaire before and after treatment with dry
      ginger (Z. officinale) extract.
This open-label, self-paired, case-control study will evaluate 180 patients presenting motion
      sickness. The primary study objective is to evaluate the use of dry Z. officinale extract
      160mg (containing 8mg gingerol) in the treatment of patients presenting motion sickness. The
      secondary objectives are to evaluate the effect of the treatment on the scores and subscores
      of the Motion Sickness Assessment Questionnaire (MSAQ) before and after treatment, as well as
      to assess treatment tolerability in this population. The total study duration will be seven
      days. A total of four specific motion sickness assessments will be performed, one
      pre-treatment and three during the treatment period, which consists of an oral dose of 160mg
      ginger extract 30 minutes prior to the trip under evaluation.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Open-label, single-group, self-paired study
primary purpose: Treatment
masking: None (Open Label)
measure: MSAQ total score change at Assessment 2
time frame: MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
description: Percentage of patients presenting change of 20 or more points on total MSAQ scores at Assessment 2 in relation to pretreatment scores.
measure: MSAQ total score change at Assessment 3
time frame: MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
description: Percentage of patients presenting change of 20 or more points on total MSAQ scores at Assessment 3 in relation to pretreatment scores.
measure: MSAQ total score change at Assessment 4
time frame: MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
description: Percentage of patients presenting change of 20 or more points on total MSAQ scores at Assessment 4 in relation to pretreatment scores.
measure: MSAQ subscore change at Assessment 2
time frame: MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
description: Percentage of patients presenting change on MSAQ subscores at Assessment 2 in relation to pretreatment scores.
measure: MSAQ subscore change at Assessment 3
time frame: MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
description: Percentage of patients presenting change on MSAQ subscores at Assessment 3 in relation to pretreatment scores.
measure: MSAQ subscore change at Assessment 4
time frame: MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
description: Percentage of patients presenting change on MSAQ subscores at Assessment 4 in relation to pretreatment scores.
measure: Adverse event occurrence
time frame: From first dose to end of study (no more than 7 days from Pretreatment visit date)
description: Number of subjects reporting adverse effects during treatment period
measure: Physician Assessment score change
time frame: Scores taken at pretreatment and at the end of the treatment period (no more than 7 days).
description: Mean Physician Assessment (10-point scale assessing overall patient condition ranging from 1 [worst] to 10 [best]) score improvement at end-of-study visit compared to pretreatment scores.
arm group label: Treatment
arm group type: Experimental
description: Oral treatment with single-dose 160mg Z. officinale extract in tablet form.
intervention type: Drug
intervention name: Z. officinale extract
description: Oral dose of 160mg dry ginger root (Z. officinale) extract in tablet form.
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Fundação Educacional Serra dos Órgãos
investigator full name: Carlos Pereira Nunes
investigator title: Principal Investigator
mesh term: Motion Sickness
sharing ipd: No