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The Effects of Elmore Oil on Patients With Osteoarthritis

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ClinicalTrials.gov Identifier: NCT01684371
Recruitment Status : Completed
First Posted : September 13, 2012
Last Update Posted : September 13, 2012
Sponsor:
Information provided by (Responsible Party):
Elmore Oil Company Pty Ltd

Tracking Information
First Submitted Date April 22, 2009
First Posted Date September 13, 2012
Last Update Posted Date September 13, 2012
Study Start Date November 2008
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 10, 2012)
Decrease in joint swelling, pain and stiffness after each treatment period [ Time Frame: Every day for 28 days ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 10, 2012)
Detect changes in Full Blood Examination parameters, liver function tests, and kidney function tests, including a CRP and ESR. [ Time Frame: 28 days ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Effects of Elmore Oil on Patients With Osteoarthritis
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.
Brief Summary 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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Population from which the cohorts will be selected are from hospital primary care arthritis clinic.
Condition
  • Degenerative Arthritis
  • Inflammation
Intervention Other: Two oily solutions (Blue Dotted and Orange Dotted Elmore Oils)
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.
Other Names:
  • Oily solution in a bottle containing olive oil, tea tree oil, vanilla and eucalyptus.
  • Another oily solution in a bottle containing olive oil.
Study Groups/Cohorts
  • Blue Dotted Elmore Oil
    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
    Intervention: Other: Two oily solutions (Blue Dotted and Orange Dotted Elmore Oils)
  • Orange Dotted Elmore Oil
    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: Other: Two oily solutions (Blue Dotted and Orange Dotted Elmore Oils)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 10, 2012)
60
Original Actual Enrollment Same as current
Actual Study Completion Date June 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diagnosed osteoarthritis based on the criteria developed by the American College of Rheumatology.

Exclusion Criteria:

  • Using other forms of topical pain relief.
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Philippines
Removed Location Countries  
 
Administrative Information
NCT Number NCT01684371
Other Study ID Numbers EO-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Elmore Oil Company Pty Ltd
Study Sponsor Elmore Oil Company Pty Ltd
Collaborators Not Provided
Investigators
Study Director: Letitia Lucero, MD Veterans Memorial Medical Centre
PRS Account Elmore Oil Company Pty Ltd
Verification Date September 2012