<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/NCT01697085</url>
  </required_header>
  <id_info>
    <org_study_id>SBMM</org_study_id>
    <nct_id>NCT01697085</nct_id>
  </id_info>
  <brief_title>Effects of Sea Buckthorn Oil on Mucous Membranes</brief_title>
  <acronym>SBMM</acronym>
  <official_title>Effects of Sea Buckthorn Oil on Mucous Membranes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aromtech Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Finnish Funding Agency for Technology and Innovation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aromtech Ltd.</source>
  <brief_summary>
    <textblock>
      Aim of this study is to investigate the effects of intake of sea buckthorn oil on mucous&#xD;
      membranes&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</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>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in dryness related symptoms of genital mucous membranes</measure>
    <time_frame>Interviews at baseline, at 2 months, at 3 moths (end of intervention), and daily during the study (symptom logbooks)</time_frame>
    <description>Interview for symptom score at baseline and study visits and a daily symptom logbook during the intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in vaginal pH</measure>
    <time_frame>At baseline, at 3 months (end of intervention)</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline in vaginal health index, vaginal dryness, vaginal maturity index, symptoms of dryness in other mucous membranes, markers of inflammation, oxidative stress and metabolic disorder in the circulation</measure>
    <time_frame>At baseline, at 3 months (end of intervention)</time_frame>
    <description>Vaginal health index: index score, change from baseline&#xD;
Vaginal dryness: moistening of pH test strip, change from baseline&#xD;
Vaginal maturity index: change from baseline&#xD;
Symptoms of dryness in other mucous membranes: daily symptom logbook during the intervention&#xD;
Markers of inflammation, oxidative stress and metabolic disorders: analysis from serum/plasma, change from baseline</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">116</enrollment>
  <condition>Mucous Membranes</condition>
  <arm_group>
    <arm_group_label>Sea buckthorn oil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 g (6 capsules)/day for three months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo oil</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>3 g (6 capsules)/day for three months</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Sea buckthorn oil</intervention_name>
    <arm_group_label>Sea buckthorn oil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo oil</intervention_name>
    <arm_group_label>Placebo oil</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women experiencing vaginal dryness&#xD;
&#xD;
          -  55-75 years of age&#xD;
&#xD;
          -  at least 12 months from menstruation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  use of estrogen replacement therapy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Risto Erkkola, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Turun Gynekologikeskus, Turku, Finland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Turun Gynekologikeskus</name>
      <address>
        <city>Turku</city>
        <zip>20100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>January 27, 2016</last_update_submitted>
  <last_update_submitted_qc>January 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aromtech Ltd.</investigator_affiliation>
    <investigator_full_name>Petra Larmo</investigator_full_name>
    <investigator_title>R&amp;D manager, Ph.D.</investigator_title>
  </responsible_party>
  <keyword>sea buckthorn</keyword>
  <keyword>mucous membrane</keyword>
  <keyword>dryness</keyword>
  <keyword>metabolic syndrome</keyword>
  <keyword>vaginal atrophy</keyword>
  <!-- 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/NCT01697085
org study id: SBMM
nct id: NCT01697085
lead sponsor: 
collaborator: 
Aim of this study is to investigate the effects of intake of sea buckthorn oil on mucous
      membranes
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline in dryness related symptoms of genital mucous membranes
time frame: Interviews at baseline, at 2 months, at 3 moths (end of intervention), and daily during the study (symptom logbooks)
description: Interview for symptom score at baseline and study visits and a daily symptom logbook during the intervention
measure: Change from baseline in vaginal pH
time frame: At baseline, at 3 months (end of intervention)
measure: Change from baseline in vaginal health index, vaginal dryness, vaginal maturity index, symptoms of dryness in other mucous membranes, markers of inflammation, oxidative stress and metabolic disorder in the circulation
time frame: At baseline, at 3 months (end of intervention)
description: Vaginal health index: index score, change from baseline
Vaginal dryness: moistening of pH test strip, change from baseline
Vaginal maturity index: change from baseline
Symptoms of dryness in other mucous membranes: daily symptom logbook during the intervention
Markers of inflammation, oxidative stress and metabolic disorders: analysis from serum/plasma, change from baseline
arm group label: Sea buckthorn oil
arm group type: Experimental
description: 3 g (6 capsules)/day for three months
arm group label: Placebo oil
arm group type: Placebo Comparator
description: 3 g (6 capsules)/day for three months
intervention type: Dietary Supplement
intervention name: Sea buckthorn oil
arm group label: Sea buckthorn oil
intervention type: Dietary Supplement
intervention name: Placebo oil
arm group label: Placebo oil
criteria: 
gender: Female
minimum age: 55 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Risto Erkkola, Professor
role: Principal Investigator
affiliation: Turun Gynekologikeskus, Turku, Finland
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Aromtech Ltd.
investigator full name: Petra Larmo
investigator title: R&D manager, Ph.D.