The Effects of Elmore Oil on Patients With Osteoarthritis

Inflammation Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684371
• Other study ID #: EO-01
• Status: Completed
• Phase: N/A
• First received: April 22, 2009
• Last updated: September 10, 2012
• Start date: November 2008
• Est. completion date: June 2009

Study information

• Verified date: September 2012
• Source: Elmore Oil Company Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Bureau of Food and DrugsPhilippines: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 90 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Degenerative Arthritis
• Inflammation
• Osteoarthritis

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.

Locations

Country	Name	City	State
Philippines	Veterans Memorial Medical Centre	Quezon City	Manila

Sponsors (1)

Lead Sponsor	Collaborator
Elmore Oil Company Pty Ltd

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in joint swelling, pain and stiffness after each treatment period		Every day for 28 days	No
Secondary	Detect changes in Full Blood Examination parameters, liver function tests, and kidney function tests, including a CRP and ESR.		28 days	Yes

External Links

•   American College of Rheumatology