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

Sponsor

Ardabil University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00670475

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis of the Knee	Drug: Piroxicam Dietary Supplement: Olive Oil	Phase 2

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

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Topical virigin olive oil

Arm

Intervention/Treatment

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 Names:

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 Names:

Topical virigin olive oil

Outcome Measures

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). [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). [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). [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). [the outcome is assessed at week 4]

Secondary Outcome Measures

the secondary measure will be changes in stiffness [the outcome is assessed at week 1]
the secondary measure will be changes in stiffness [the outcome is assessed at week 2]
the secondary measure will be changes in stiffness [the outcome is assessed at week 3]
the secondary measure will be changes in stiffness [the outcome is assessed at week 4]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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