The Effects of Elmore Oil on Patients With Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elmore Oil Company Pty Ltd
ClinicalTrials.gov Identifier:
NCT01684371
First received: April 22, 2009
Last updated: September 10, 2012
Last verified: September 2012

April 22, 2009
September 10, 2012
November 2008
April 2009   (final data collection date for primary outcome measure)
Decrease in joint swelling, pain and stiffness after each treatment period [ Time Frame: Every day for 28 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01684371 on ClinicalTrials.gov Archive Site
Detect changes in Full Blood Examination parameters, liver function tests, and kidney function tests, including a CRP and ESR. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Effects of Elmore Oil on Patients With Osteoarthritis
The Effects of a Herbal Remedy, Elmore Oil, on Pain and Well-being in Patients With Osteoarthritis: A Double-blind, Placebo-controlled, Randomised Trial.

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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Population from which the cohorts will be selected are from hospital primary care arthritis clinic.

  • Degenerative Arthritis
  • Inflammation
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.
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Using other forms of topical pain relief.
Both
45 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Philippines
 
NCT01684371
EO-01
No
Elmore Oil Company Pty Ltd
Elmore Oil Company Pty Ltd
Not Provided
Study Director: Letitia Lucero, MD Veterans Memorial Medical Centre
Elmore Oil Company Pty Ltd
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP