Comparative Study of Olive Oil With Piroxicam Gel in Osteoarthritis of the Knee
Information source: Ardabil University of Medical Sciences
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis of the Knee
Intervention: Piroxicam (Drug); Olive Oil (Dietary Supplement)
Phase: Phase 2
Status: Recruiting
Sponsored by: Ardabil University of Medical Sciences Official(s) and/or principal investigator(s):
shahab bohlooli, PhD, Principal Investigator, Affiliation: Pharmacology Dept, Faculty of Medicine, ArdabilUMS
Marina Jastan, MD, Principal Investigator, Affiliation: rheomatology clinic, faculty of medicine, ArdabilUMS
Overall contact:
shahab Bohlooli, PhD, Phone: 0098-451-5512005, Email: shahab.bohlooli@arums.ac.ir
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.
Clinical Details
Official title: Comparative Study of Olive Oil With Piroxicam Gel in Osteoarthritis of the Knee
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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).
Secondary outcome: the secondary measure will be changes in stiffness
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.
Eligibility
Minimum age: 40 Years.
Maximum age: 85 Years.
Gender(s): Both.
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;
Locations and Contacts
shahab Bohlooli, PhD, Phone: 0098-451-5512005, Email: shahab.bohlooli@arums.ac.ir
ArdabiUMS clinic of rheumatology, Ardabil 56197, Iran, Islamic Republic of; Recruiting
Marina Jastan, MD, Email: m.jastan@arums.ac.ir
Shahab Bohlooli, PhD, Principal Investigator
Marina Jastan, MD, Sub-Investigator
Additional Information
Starting date: April 2008
Ending date: December 2008
Last updated: May 12, 2008
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