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Trial NCT00670475

Resource URI: http://static.linkedct.org/resource/trials/NCT00670475
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/54855>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/55941>
linkedct:brief_title Comparative Study of Olive Oil With Piroxicam Gel in Osteoarthritis of the Knee
linkedct:condition <http://static.linkedct.org/resource/condition/9361>
linkedct:criteria Inclusion Criteria: - 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). Exclusion Criteria: - 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; - 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;
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 85 Years
linkedct:eligibility_minimum_age 40 Years
linkedct:end_date February 2009
linkedct:enrollment 200 (xsd:int)
linkedct:firstreceived_date April 29, 2008
linkedct:has_dmc Yes
linkedct:id NCT00670475
linkedct:intervention <http://static.linkedct.org/resource/intervention/40448>
linkedct:intervention <http://static.linkedct.org/resource/intervention/63030>
rdfs:label Trial NCT00670475
linkedct:lastchanged_date November 19, 2008
linkedct:lead_sponsor_agency Ardabil University of Medical Sciences
linkedct:location <http://static.linkedct.org/resource/location/73096>
linkedct:nct_id NCT00670475
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Comparative Study of Olive Oil With Piroxicam Gel in Osteoarthritis of the Knee
linkedct:org_study_id 1/86010
linkedct:overall_contact_email shahab.bohlooli@arums.ac.ir
linkedct:overall_contact_last_name shahab Bohlooli, PhD
linkedct:overall_contact_phone 0098-451-5512005
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/37810>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/52407>
linkedct:overall_status Recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/1388>
foaf:page <http://clinicaltrials.gov/show/NCT00670475>
linkedct:phase Phase 2
linkedct:primary_completion_date January 2009
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/73628>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/109673>
linkedct:source Ardabil University of Medical Sciences
linkedct:start_date April 2008
linkedct:study_design Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date November 2008