Comparative Study of Olive Oil With Piroxicam Gel in Osteoarthritis of the Knee

Official Title: “Comparative Study of Olive Oil With Piroxicam Gel in Osteoarthritis of the Knee”

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.

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.

Intervention(s) in this Clinical Trial

• 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.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• 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.
• 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.

Primary 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
    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
    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
    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
    Safety Issue?: Yes

Secondary Measures

• the secondary measure will be changes in stiffness
  • Time Frame: the outcome is assessed at week 1
    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
    

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;

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Ardabil University of Medical Sciences Other

Overall Clinical Trial Officials and Contacts

shahab bohlooli, PhD Principal Investigator Pharmacology Dept, Faculty of Medicine, ArdabilUMS  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00670475

Study ID Number: 1/86010

ClinicalTrials.gov Identifier: NCT00670475

Health Authority: Iran: Ministry of Health