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
  Purpose

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.


Condition Intervention
Degenerative Arthritis
Inflammation
Other: Two oily solutions (Blue Dotted and Orange Dotted Elmore Oils)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Elmore Oil Company Pty Ltd:

Primary Outcome Measures:
  • Decrease in joint swelling, pain and stiffness after each treatment period [ Time Frame: Every day for 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: November 2008
Study Completion Date: June 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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.
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.
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.

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.

  Eligibility

Ages Eligible for Study:   45 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684371

Locations
Philippines
Veterans Memorial Medical Centre
Quezon City, Manila, Philippines, 1100
Sponsors and Collaborators
Elmore Oil Company Pty Ltd
Investigators
Study Director: Letitia Lucero, MD Veterans Memorial Medical Centre
  More Information

Additional Information:
No publications provided

Responsible Party: Elmore Oil Company Pty Ltd
ClinicalTrials.gov Identifier: NCT01684371     History of Changes
Other Study ID Numbers: EO-01
Study First Received: April 22, 2009
Last Updated: September 10, 2012
Health Authority: Philippines: Bureau of Food and Drugs
Philippines: Department of Health

Keywords provided by Elmore Oil Company Pty Ltd:
Osteoarthritis
Osteoarthritic pain
Arthritic pain
Arthritis
joint inflammation
Arthralgia

Additional relevant MeSH terms:
Arthritis
Inflammation
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes
Rheumatic Diseases
Pharmaceutical Solutions
Tea Tree Oil
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 21, 2014