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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Degenerative Arthritis
• Intervention / Treatment: Other: Two oily solutions (Blue Dotted and Orange Dotted Elmore Oils)

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
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Philippines
  • Manila
    • Quezon City, Manila, Philippines, 1100
      • Veterans Memorial Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Using other forms of topical pain relief.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Decrease in joint swelling, pain and stiffness after each treatment period	Every day for 28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Detect changes in Full Blood Examination parameters, liver function tests, and kidney function tests, including a CRP and ESR.	28 days

Collaborators and Investigators

• Sponsor: Elmore Oil Company Pty Ltd
• Investigators: Study Director: Letitia Lucero, MD, Veterans Memorial Medical Centre

Publications and helpful links

Helpful Links

• American College of Rheumatology

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: April 22, 2009
• First Submitted That Met QC Criteria: September 10, 2012
• First Posted (Estimate): September 13, 2012

Study Record Updates

• Last Update Posted (Estimate): September 13, 2012
• Last Update Submitted That Met QC Criteria: September 10, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Arthritis; Osteoarthritis; Osteoarthritic pain; Arthritic pain; joint inflammation; Arthralgia
• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Inflammation; Anti-Infective Agents, Local; Anti-Infective Agents; Tea Tree Oil; Pharmaceutical Solutions
• Other Study ID Numbers: EO-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No