Comparative Study of Olive Oil With Piroxicam Gel in Osteoarthritis of the Knee - Full Text View

Sponsor:	Ardabil University of Medical Sciences
Information provided by:	Ardabil University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00670475

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis of the Knee	Drug: Piroxicam Dietary Supplement: Olive Oil	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Comparative Study of Olive Oil With Piroxicam Gel in Osteoarthritis of the Knee

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Piroxicam

U.S. FDA Resources

Further study details as provided by Ardabil University of Medical Sciences:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

the secondary measure will be changes in stiffness [ Time Frame: the outcome is assessed at week 1 ] [ Designated as safety issue: No ]
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 ]

Enrollment:	60
Study Start Date:	April 2008
Study Completion Date:	April 2010
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: P (Pircoxicam Group) 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.	Drug: Piroxicam 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. Other Name: Piroxicam topical gel
Experimental: O (olive oil group) 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.	Dietary Supplement: 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. Other Name: Topical virigin olive oil

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

Ages Eligible for Study:	40 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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;

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670475

Locations

Iran, Islamic Republic of
ArdabiUMS clinic of rheumatology
Ardabil, Iran, Islamic Republic of, 56197

Sponsors and Collaborators

Ardabil University of Medical Sciences

Investigators

Principal Investigator:	shahab bohlooli, PhD	Pharmacology Dept, Faculty of Medicine, ArdabilUMS
Principal Investigator:	Marina Jastan, MD	rheomatology clinic, faculty of medicine, ArdabilUMS

More Information

No publications provided

Responsible Party:	Shahab Bohlooli, pharmacology dept, faculty of medicine, ArdabilUMS
ClinicalTrials.gov Identifier:	NCT00670475 History of Changes
Other Study ID Numbers:	1/86010
Study First Received:	April 29, 2008
Last Updated:	April 28, 2010
Health Authority:	Iran: Ministry of Health

Keywords provided by Ardabil University of Medical Sciences:

osteoarthritis
Knee
virgin olive oil
piroxicam
Topical

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Piroxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2012