<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/NCT02981238</url>
  </required_header>
  <id_info>
    <org_study_id>PiL-Obs-SLEE-PI-015</org_study_id>
    <nct_id>NCT02981238</nct_id>
  </id_info>
  <brief_title>Phytotherapy Strategy for Sleep Disorders Related to Anxiety With a Combination of Eschscholtzia and Valerian Extracts</brief_title>
  <official_title>Descriptive Study of a Phytotherapy Strategy for Sleep Disorders Related to Anxiety With Phytostandard® Eschscholtzia and Valerian, a Dietary Supplement Based on Eschscholtzia and Valerian Extracts</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PiLeJe</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PiLeJe</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to evaluate the effect of a one-month supplementation with&#xD;
      Phytostandard® Eschscholtzia and valerian on the Insomnia Severity Index (ISI), in insomniac&#xD;
      so-called adjustment subjects (occasional or short-term insomnia)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For this study, 40 patients are going to be included. They will have a supplementation of&#xD;
      Phytostandard® Eschscholtzia and valerian, from 2 to 4 tablets per day during 28 days.&#xD;
&#xD;
      on the one hand, during the two visits (inclusion and follow-up), the investigator completes&#xD;
      the Hamilton Anxiety Scale (HAM-A). During the inclusion visit, he completes with his patient&#xD;
      the epworth scale.&#xD;
&#xD;
      on the other hand, patients complete ISI twice : just after the inclusion visit and just&#xD;
      before the follow-up visit. He completes two sleep schedules, the first one during the first&#xD;
      week of complement and the second one during the fourth.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 20, 2016</start_date>
  <completion_date type="Actual">January 12, 2017</completion_date>
  <primary_completion_date type="Actual">January 12, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>evolution of the Index of Severity of Insomnia (ISI)</measure>
    <time_frame>day 0 and day 28</time_frame>
    <description>This outcome is compared with ISI at day 0 : we compared both the global score and each item scores</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evolution of Hamilton Anxiety Scale (HAM-A)</measure>
    <time_frame>day 0 and day 28</time_frame>
    <description>This outcome is compared with HAM-A at day 0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Satisfaction</measure>
    <time_frame>day 28</time_frame>
    <description>using a likert scale of satisfaction</description>
  </secondary_outcome>
  <enrollment type="Actual">36</enrollment>
  <condition>Sleep Disorders Related to Anxiety</condition>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Phytostandard® Eschscholtzia / Valerian</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients suffering from sleep disorders linked to anxiety&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria of patients:&#xD;
&#xD;
          -  Currently having sleep disorders related to an anxiety and / or having some in the&#xD;
             last 3 months&#xD;
&#xD;
          -  Having an alteration of sleep on the previous month which results in a score strictly&#xD;
             greater than 7 according to the index of Severity of Insomnia (ISI)&#xD;
&#xD;
          -  For which the investigator freely advises his patient a complement with Phytostandard®&#xD;
             Eschscholtzia and Valerian&#xD;
&#xD;
          -  For which the patient freely agrees to complement itself after advice of his doctor&#xD;
             with Phytostandard® Eschscholtzia and Valerian&#xD;
&#xD;
          -  Having been informed of the study and accepting the collection and processing of their&#xD;
             data&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suffering from an anxiety resulting in a HAM-A score (Hamilton Anxiety Rating Scale)&#xD;
             greater than or equal to 30&#xD;
&#xD;
          -  With a score on Epworth's sleepiness scale strictly greater than 10 (suggestive of a&#xD;
             major hypersomnia)&#xD;
&#xD;
          -  Presenting symptoms of sleep apnea syndrome&#xD;
&#xD;
          -  Presenting symptoms of a restless legs syndrome&#xD;
&#xD;
          -  Presenting a chronic pain syndrome requiring the daily intake of analgesic(s)&#xD;
&#xD;
          -  Under psychotropic treatment (neuroleptic, anxiolytic, antidepressant or hypnotic) or&#xD;
             under treatment to alter the waking state (antihistamines, beta-blockers, some cough&#xD;
             syrups, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>68 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pileje Network of general practitioners</name>
      <address>
        <city>Paris</city>
        <zip>75000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>July 13, 2018</last_update_submitted>
  <last_update_submitted_qc>July 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2018</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>Sleep Wake Disorders</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Anxiety Disorders</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/NCT02981238
org study id: PiL-Obs-SLEE-PI-015
nct id: NCT02981238
lead sponsor: 
has dmc: No
The aim of the study is to evaluate the effect of a one-month supplementation with
      Phytostandard® Eschscholtzia and valerian on the Insomnia Severity Index (ISI), in insomniac
      so-called adjustment subjects (occasional or short-term insomnia)
For this study, 40 patients are going to be included. They will have a supplementation of
      Phytostandard® Eschscholtzia and valerian, from 2 to 4 tablets per day during 28 days.

      on the one hand, during the two visits (inclusion and follow-up), the investigator completes
      the Hamilton Anxiety Scale (HAM-A). During the inclusion visit, he completes with his patient
      the epworth scale.

      on the other hand, patients complete ISI twice : just after the inclusion visit and just
      before the follow-up visit. He completes two sleep schedules, the first one during the first
      week of complement and the second one during the fourth.
observational model: Case-Only
time perspective: Prospective
measure: evolution of the Index of Severity of Insomnia (ISI)
time frame: day 0 and day 28
description: This outcome is compared with ISI at day 0 : we compared both the global score and each item scores
measure: Evolution of Hamilton Anxiety Scale (HAM-A)
time frame: day 0 and day 28
description: This outcome is compared with HAM-A at day 0
measure: Percentage of Satisfaction
time frame: day 28
description: using a likert scale of satisfaction
intervention type: Dietary Supplement
intervention name: Phytostandard® Eschscholtzia / Valerian
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 68 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Sleep Wake Disorders
mesh term: Parasomnias
mesh term: Anxiety Disorders