Degenerative ArthritisNCT01684371
The Effects of Elmore Oil on Patients With Osteoarthritis
An observational study of Degenerative Arthritis and Inflammation, run by Elmore Oil Company Pty Ltd at 1 site in Philippines.
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. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Degenerative Arthritis, Inflammation
- What is being tested?
- Two oily solutions (Blue Dotted and Orange Dotted Elmore Oils)
- How many people
- 60 participants
- Where
- 1 sitePhilippines
- Study dates
- Nov 2008to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population from which the cohorts will be selected are from hospital primary care arthritis clinic.
Who may be able to join
- Diagnosed osteoarthritis based on the criteria developed by the American College of Rheumatology.
Who cannot join
- Using other forms of topical pain relief.
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Veterans Memorial Medical Centre
Quezon City, Manila, 1100
About this study
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.
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.
Read the 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.
- Conditions
- Degenerative Arthritis, Inflammation
- Being tested
- Two oily solutions (Blue Dotted and Orange Dotted Elmore Oils)
- Keywords
- Osteoarthritis, Osteoarthritic pain, Arthritic pain, Arthritis, joint inflammation, Arthralgia
- Medical subject headings
- Osteoarthritis, Inflammation, Arthritis, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two oily solutions (Blue Dotted and Orange Dotted Elmore Oils)Other
Also called Oily solution in a bottle containing olive oil, tea tree oil, vanilla and eucalyptus., Another oily solution in a bottle containing olive oil.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Two oily solutions (Blue Dotted and Orange Dotted Elmore Oils) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in joint swelling, pain and stiffness after each treatment period
Measured: 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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2012 (estimated)
- Study startNov 2008
- Primary completionApr 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elmore Oil Company Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Letitia Lucero, MD, Study director, Veterans Memorial Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684371
- Sponsor's protocol ID
- EO-01
- Status last verified
- Sep 2012
- First submitted
- 22 Apr 2009
- Last updated
- 13 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01684371
- Acronym / sponsor ID
- EO-01
- Conditions
- Degenerative Arthritis, Inflammation
- Keywords
- Osteoarthritis, Osteoarthritic pain, Arthritic pain, Arthritis, joint inflammation, Arthralgia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Elmore Oil Company Pty LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 13 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blue Dotted Elmore Oil | – | Other: Two oily solutions (Blue Dotted and Orange Dotted Elmore Oils)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 |
| Orange Dotted Elmore Oil | – | Other: Two oily solutions (Blue Dotted and Orange Dotted Elmore Oils)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. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population from which the cohorts will be selected are from hospital primary care arthritis clinic.
Key inclusion criteria (1 listed)
- Diagnosed osteoarthritis based on the criteria developed by the American College of Rheumatology.
Key exclusion criteria (1 listed)
- Using other forms of topical pain relief.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Two oily solutions (Blue Dotted and Orange Dotted Elmore Oils)Also: Oily solution in a bottle containing olive oil, tea tree oil, vanilla and eucalyptus., Another oily solution in a bottle containing olive oil.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 | Blue Dotted Elmore Oil, Orange Dotted Elmore Oil |
Primary outcome
Decrease in joint swelling, pain and stiffness after each treatment period
Time frame: Every day for 28 days
1 secondary outcome
Detect changes in Full Blood Examination parameters, liver function tests, and kidney function tests, including a CRP and ESR.
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2012.
- American College of RheumatologyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Letitia Lucero, MD study director
Veterans Memorial Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Arthritis and Inflammation, run by Elmore Oil Company Pty Ltd at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in joint swelling, pain and stiffness after each treatment period (time frame: Every day for 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2012; AzTrials last refreshed its copy on 8 Nov 2026.