<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/NCT01684371</url>
  </required_header>
  <id_info>
    <org_study_id>EO-01</org_study_id>
    <nct_id>NCT01684371</nct_id>
  </id_info>
  <brief_title>The Effects of Elmore Oil on Patients With Osteoarthritis</brief_title>
  <official_title>The Effects of a Herbal Remedy, Elmore Oil, on Pain and Well-being in Patients With Osteoarthritis: A Double-blind, Placebo-controlled, Randomised Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Elmore Oil Company Pty Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Elmore Oil Company Pty Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The treatment of osteoarthritis, a disease that eventually affects the majority of the older&#xD;
      population, involves the alleviation of symptoms such as pain and stiffness, and the&#xD;
      reduction of inflammation. A double-blind, placebo-controlled, crossover study will be&#xD;
      performed to examine the effect of topical application of Elmore Oil, a herbal remedy&#xD;
      (containing Eucalyptus oil, Tea tree oil, Olive oil and Vanilla), which has recently been&#xD;
      reported to have anti-inflammatory properties, on the symptoms of osteoarthritis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sixty patients were randomly selected and approved for the study, 30 patients with even&#xD;
      numbers received the blue dotted Elmore oil and 30 patients with odd numbers got the orange&#xD;
      dotted Elmore and were advised to apply 3x daily on the affected knees respectively for four&#xD;
      weeks. On the fifth week, they stopped application for 7 days as flush out period. Then on&#xD;
      the 6th week a cross over was done on the patients - the blue dotted patients, this time&#xD;
      received the orange dotted Elmore Oil and vice-versa and did the application three times&#xD;
      daily for another 4 weeks. All throughout the usage, they filled out their diaries (noting&#xD;
      the degree of pain, feeling of well being (improved sleep, mobility, ability to do their&#xD;
      daily activities at home or at work). A pre-application base line laboratory tests were done,&#xD;
      after 4 weeks and after 8 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2008</start_date>
  <completion_date type="Actual">June 2009</completion_date>
  <primary_completion_date type="Actual">April 2009</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Decrease in joint swelling, pain and stiffness after each treatment period</measure>
    <time_frame>Every day for 28 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Detect changes in Full Blood Examination parameters, liver function tests, and kidney function tests, including a CRP and ESR.</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Degenerative Arthritis</condition>
  <condition>Inflammation</condition>
  <arm_group>
    <arm_group_label>Blue Dotted Elmore Oil</arm_group_label>
    <description>Patients applied the above oil 3 times daily for four weeks and on the fifth week stopped the application completely for the flush out period before switching to Orange Dotted Elmore Oil</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Orange Dotted Elmore Oil</arm_group_label>
    <description>Patients give this oil applied it three times daily on the affected knees for four weeks and on the fifth week, stopped the application totally for the flush out period before switching to the Blue Dotted Elmore Oil.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Two oily solutions (Blue Dotted and Orange Dotted Elmore Oils)</intervention_name>
    <description>Thirty participants received Blue Dotted Elmore Oil and another thirty received the Orange dotted Elmore Oil, they applied the oils three times daily on the affected knees for four weeks and stopped usage on the fifth week (flush out period) and on the 6 week, the two group switched to Orange and Blue Elmore Oil respectively. All throughout applications, they filled out their diaries to indicate changes in their mobility, moods, feeling of well being and ability to do their daily work at home or at work every week.</description>
    <arm_group_label>Blue Dotted Elmore Oil</arm_group_label>
    <arm_group_label>Orange Dotted Elmore Oil</arm_group_label>
    <other_name>Oily solution in a bottle containing olive oil, tea tree oil, vanilla and eucalyptus.</other_name>
    <other_name>Another oily solution in a bottle containing olive oil.</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Population from which the cohorts will be selected are from hospital primary care arthritis&#xD;
        clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed osteoarthritis based on the criteria developed by the American College of&#xD;
             Rheumatology.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Using other forms of topical pain relief.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Letitia Lucero, MD</last_name>
    <role>Study Director</role>
    <affiliation>Veterans Memorial Medical Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Veterans Memorial Medical Centre</name>
      <address>
        <city>Quezon City</city>
        <state>Manila</state>
        <zip>1100</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Philippines</country>
  </location_countries>
  <link>
    <url>http://www.rheumatology.org</url>
    <description>American College of Rheumatology</description>
  </link>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>April 22, 2009</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>September 10, 2012</last_update_submitted>
  <last_update_submitted_qc>September 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 13, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Osteoarthritis</keyword>
  <keyword>Osteoarthritic pain</keyword>
  <keyword>Arthritic pain</keyword>
  <keyword>Arthritis</keyword>
  <keyword>joint inflammation</keyword>
  <keyword>Arthralgia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tea Tree Oil</mesh_term>
    <mesh_term>Pharmaceutical Solutions</mesh_term>
  </intervention_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/NCT01684371
org study id: EO-01
nct id: NCT01684371
lead sponsor: 
has dmc: No
The treatment of osteoarthritis, a disease that eventually affects the majority of the older
      population, involves the alleviation of symptoms such as pain and stiffness, and the
      reduction of inflammation. A double-blind, placebo-controlled, crossover study will be
      performed to examine the effect of topical application of Elmore Oil, a herbal remedy
      (containing Eucalyptus oil, Tea tree oil, Olive oil and Vanilla), which has recently been
      reported to have anti-inflammatory properties, on the symptoms of osteoarthritis.
Sixty patients were randomly selected and approved for the study, 30 patients with even
      numbers received the blue dotted Elmore oil and 30 patients with odd numbers got the orange
      dotted Elmore and were advised to apply 3x daily on the affected knees respectively for four
      weeks. On the fifth week, they stopped application for 7 days as flush out period. Then on
      the 6th week a cross over was done on the patients - the blue dotted patients, this time
      received the orange dotted Elmore Oil and vice-versa and did the application three times
      daily for another 4 weeks. All throughout the usage, they filled out their diaries (noting
      the degree of pain, feeling of well being (improved sleep, mobility, ability to do their
      daily activities at home or at work). A pre-application base line laboratory tests were done,
      after 4 weeks and after 8 weeks.
observational model: Cohort
time perspective: Prospective
measure: Decrease in joint swelling, pain and stiffness after each treatment period
time frame: Every day for 28 days
measure: Detect changes in Full Blood Examination parameters, liver function tests, and kidney function tests, including a CRP and ESR.
time frame: 28 days
arm group label: Blue Dotted Elmore Oil
description: Patients applied the above oil 3 times daily for four weeks and on the fifth week stopped the application completely for the flush out period before switching to Orange Dotted Elmore Oil
arm group label: Orange Dotted Elmore Oil
description: Patients give this oil applied it three times daily on the affected knees for four weeks and on the fifth week, stopped the application totally for the flush out period before switching to the Blue Dotted Elmore Oil.
intervention type: Other
intervention name: Two oily solutions (Blue Dotted and Orange Dotted Elmore Oils)
description: Thirty participants received Blue Dotted Elmore Oil and another thirty received the Orange dotted Elmore Oil, they applied the oils three times daily on the affected knees for four weeks and stopped usage on the fifth week (flush out period) and on the 6 week, the two group switched to Orange and Blue Elmore Oil respectively. All throughout applications, they filled out their diaries to indicate changes in their mobility, moods, feeling of well being and ability to do their daily work at home or at work every week.
arm group label: Blue Dotted Elmore Oil
arm group label: Orange Dotted Elmore Oil
other name: Oily solution in a bottle containing olive oil, tea tree oil, vanilla and eucalyptus.
other name: Another oily solution in a bottle containing olive oil.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 45 Years
maximum age: 90 Years
healthy volunteers: No
last name: Letitia Lucero, MD
role: Study Director
affiliation: Veterans Memorial Medical Centre
facility: 
country: Philippines
url: http://www.rheumatology.org
description: American College of Rheumatology
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Osteoarthritis
mesh term: Inflammation
mesh term: Tea Tree Oil
mesh term: Pharmaceutical Solutions