Osteoarthritis of the KneePhase 2NCT00670475
Comparative Study of Olive Oil With Piroxicam Gel in Osteoarthritis of the Knee
A Phase 2 study testing Piroxicam and Olive Oil in people with Osteoarthritis of the Knee, run by Ardabil University of Medical Sciences at 1 site in Iran.
Trial summary
this is a randomized double blinded trial which is conducted to measure the efficacy of topical virgin olive oil on osteoarthritis of knee that will be done in contrast to standard piroxicam gel. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Piroxicam and Olive Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Apr 2008to Apr 2010
- Phase
- Phase 2
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and non-pregnant women, age 40-85 years with primary OA of at least one knee, and a flare of pain after withdrawal of prior therapy with either an oral NSAID or acetaminophen (used at least 3 days per week during the previous month).
Who cannot join
- secondary arthritis related to systemic inflammatory arthritis (including rheumatoid arthritis, psoriatic arthritis, post-infectious arthritis and metabolic arthritis, traumatic arthritis or surgical joint replacement); corticosteroid use:
- oral corticosteroid within the previous 14 days, or
- intramuscular corticosteroid within 30 days, or
- intraarticular corticosteroid into the study knee within 90 days,
- intra-articular corticosteroid into any other joint within 30 days, or
- topical corticosteroid at the site of application within 14 days;
Show all 12Show fewer
- ongoing use of prohibited medication including NSAID, other oral analgesic, muscle relaxant, or low-dose antidepressant for any chronic pain management; - ongoing use of glucosamine or chondroitin (unless used continuously for 90 days prior to study entry);
- sensitivity to diclofenac, acetylsalicylic acid (ASA) or any other NSAID, acetaminophen, dimethyl sulphoxide, propylene glycol, glycerine or ethanol; clinically-active renal, hepatic or peptic ulcer disease;
- history of alcohol or drug abuse;
- lactation;
- concomitant skin disease at the application site;
- current application for disability benefits on the basis of knee osteoarthritis; fibromyalgia; other painful or disabling condition affecting the knee;
Trial locations and contacts
1 site in 1 country.
About this study
this is a randomized double blinded trial which is conducted to measure the efficacy of topical virgin olive oil on osteoarthritis of knee that will be done in contrast to standard piroxicam gel.
Read the detailed description
application of herbal product has old history in therapy of human diseases. olive oil is one of the important diet in Iran which its efficacy in reducing of rheumatic pains was pointed out by Avicenna in 10th century. Nevertheless, its efficacy is not confirmed by scientific study.
in this double blinded study, 200 patients with diagnosed osteoarthritis of knee will be recruited that will randomly be assigned in piroxicam or olive oil group. the piroxicam gel or olive oil will be repackaged in anonymous tubes, which only recognizable via codes. the patients or visiting clinicians will be unaware of content of tubes. the final assessor will be blind to groups and interventions.
the efficacy of therapies will be evaluated by means of WOMAC and PGs standard questionnaires.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Piroxicam, Olive Oil
- Keywords
- osteoarthritis, Knee, virgin olive oil, piroxicam, Topical
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiroxicamDrug
Also called Piroxicam topical gel
In this interventional arm gel of piroxicam (manufactured by Iran najo co,Iran), repackaged in a 60 g anonymous tubes will be administered to the patients.
Olive OilDietary supplement
Also called Topical virigin olive oil
virgin olive oil prepared directly from olive fruit from "olive gardens of north of iran, Gilan province" will packaged in a 60 g anonymous tubes.
| Study group | Role | What they receive |
|---|---|---|
| P (Pircoxicam Group) | Active comparator | in this arm 100 patients with osteoarthritis of knee will receive piroxicam gel in blinded 60 grams tubes,they will be instructed to use 1 gram of piroxicam gel (with inserted dispensing device) three times in a day on the affected knee. Receives: Drug: Piroxicam |
| O (olive oil group) | Experimental | in this arm 100 patients with osteoarthritis of knee will receive virgin olive oil in blinded 60 grams tubes,they will be instructed to use 1 gram of olive oil (with inserted dispensing device) three times in a day on the affected knee. Receives: Dietary Supplement: Olive Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA).
Measured: the outcome is assessed at week 1
The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA).
Measured: the outcome is assessed at week 2
The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA).
Measured: the outcome is assessed at week 3
The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA).
Measured: the outcome is assessed at week 4
Secondary outcomes (4)
the secondary measure will be changes in stiffness
Measured: the outcome is assessed at week 1
the secondary measure will be changes in stiffness
Measured: the outcome is assessed at week 2
the secondary measure will be changes in stiffness
Measured: the outcome is assessed at week 3
the secondary measure will be changes in stiffness
Measured: the outcome is assessed at week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2008 (estimated)
- Study startApr 2008
- Primary completionMay 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardabil University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- shahab bohlooli, PhD, Principal investigator, Pharmacology Dept, Faculty of Medicine, ArdabilUMSMarina Jastan, MD, Principal investigator, rheomatology clinic, faculty of medicine, ArdabilUMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670475
- Sponsor's protocol ID
- 1/86010
- Status last verified
- Apr 2010
- First submitted
- 29 Apr 2008
- Last updated
- 29 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Olive Oil With Piroxicam Gel in Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00670475
- Acronym / sponsor ID
- 1/86010
- Conditions
- Osteoarthritis of the Knee
- Keywords
- osteoarthritis, Knee, virgin olive oil, piroxicam, Topical
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ardabil University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 1 May 2008 (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.
this is a randomized double blinded trial which is conducted to measure the efficacy of topical virgin olive oil on osteoarthritis of knee that will be done in contrast to standard piroxicam gel.
Detailed description
application of herbal product has old history in therapy of human diseases. olive oil is one of the important diet in Iran which its efficacy in reducing of rheumatic pains was pointed out by Avicenna in 10th century. Nevertheless, its efficacy is not confirmed by scientific study.
in this double blinded study, 200 patients with diagnosed osteoarthritis of knee will be recruited that will randomly be assigned in piroxicam or olive oil group. the piroxicam gel or olive oil will be repackaged in anonymous tubes, which only recognizable via codes. the patients or visiting clinicians will be unaware of content of tubes. the final assessor will be blind to groups and interventions.
the efficacy of therapies will be evaluated by means of WOMAC and PGs standard questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P (Pircoxicam Group) | Active comparator | Drug: Piroxicamin this arm 100 patients with osteoarthritis of knee will receive piroxicam gel in blinded 60 grams tubes,they will be instructed to use 1 gram of piroxicam gel (with inserted dispensing device) three times in a day on the affected knee. |
| O (olive oil group) | Experimental | Dietary Supplement: Olive Oilin this arm 100 patients with osteoarthritis of knee will receive virgin olive oil in blinded 60 grams tubes,they will be instructed to use 1 gram of olive oil (with inserted dispensing device) three times in a day on the affected knee. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- men and non-pregnant women, age 40-85 years with primary OA of at least one knee, and a flare of pain after withdrawal of prior therapy with either an oral NSAID or acetaminophen (used at least 3 days per week during the previous month).
Key exclusion criteria (12 listed)
- secondary arthritis related to systemic inflammatory arthritis (including rheumatoid arthritis, psoriatic arthritis, post-infectious arthritis and metabolic arthritis, traumatic arthritis or surgical joint replacement); corticosteroid use:
- ongoing use of prohibited medication including NSAID, other oral analgesic, muscle relaxant, or low-dose antidepressant for any chronic pain management; - ongoing use of glucosamine or chondroitin (unless used continuously for 90 days prior to study entry);
- sensitivity to diclofenac, acetylsalicylic acid (ASA) or any other NSAID, acetaminophen, dimethyl sulphoxide, propylene glycol, glycerine or ethanol; clinically-active renal, hepatic or peptic ulcer disease;
- history of alcohol or drug abuse;
- lactation;
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 |
|---|---|---|
| PiroxicamAlso: Piroxicam topical gelIn this interventional arm gel of piroxicam (manufactured by Iran najo co,Iran), repackaged in a 60 g anonymous tubes will be administered to the patients. | Drug | P (Pircoxicam Group) |
| Olive OilAlso: Topical virigin olive oilvirgin olive oil prepared directly from olive fruit from "olive gardens of north of iran, Gilan province" will packaged in a 60 g anonymous tubes. | Dietary supplement | O (olive oil group) |
Primary outcome
The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA).
Time frame: the outcome is assessed at week 1
The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA).
Time frame: the outcome is assessed at week 2
The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA).
Time frame: the outcome is assessed at week 3
The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA).
Time frame: the outcome is assessed at week 4
4 secondary outcomes
the secondary measure will be changes in stiffness
Time frame: the outcome is assessed at week 1
the secondary measure will be changes in stiffness
Time frame: the outcome is assessed at week 2
the secondary measure will be changes in stiffness
Time frame: the outcome is assessed at week 3
the secondary measure will be changes in stiffness
Time frame: the outcome is assessed at week 4
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 29 Apr 2010.
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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.
shahab bohlooli, PhD principal investigator
Pharmacology Dept, Faculty of Medicine, ArdabilUMS
Marina Jastan, MD principal investigator
rheomatology clinic, faculty of medicine, ArdabilUMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Piroxicam and Olive Oil in people with Osteoarthritis of the Knee, run by Ardabil University of Medical Sciences at 1 site in Iran.
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 12 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 29 Apr 2010. 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 Iran. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA). (time frame: the outcome is assessed at week 1). The study lists 4 primary outcomes in all. 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 29 Apr 2010.