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Completed

NCT Number: NCT01684371

The Effects of Elmore Oil on Patients With Osteoarthritis

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.

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Key information

Conditions

Degenerative Arthritis Arthralgia Arthritis Inflammation Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

45 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Veterans Memorial Medical Centre

Quezon City, Manila, 1100, Philippines

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Using other forms of topical pain relief.

Treatment and study plan

Two oily solutions (Blue Dotted and Orange Dotted Elmore Oils)

Other

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.

Primary outcomes

  1. Decrease in joint swelling, pain and stiffness after each treatment period

    Time frame: Every day for 28 days

Secondary outcomes

  1. Detect changes in Full Blood Examination parameters, liver function tests, and kidney function tests, including a CRP and ESR.

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Elmore Oil Company Pty Ltd

Industry

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 13, 2012
Registry last updated
Sep 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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