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Completed

NCT Number: NCT00670475

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.

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ArdabiUMS clinic of rheumatology

Ardabil, Ardabil Province, 56197, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

piroxicam

Drug

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

Olive Oil

Dietary Supplement

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

Primary outcomes

  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).

    Time frame: the outcome is assessed at week 1

  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).

    Time frame: the outcome is assessed at week 2

  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).

    Time frame: the outcome is assessed at week 3

  4. 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

Secondary outcomes

  1. the secondary measure will be changes in stiffness

    Time frame: the outcome is assessed at week 1

  2. the secondary measure will be changes in stiffness

    Time frame: the outcome is assessed at week 2

  3. the secondary measure will be changes in stiffness

    Time frame: the outcome is assessed at week 3

  4. the secondary measure will be changes in stiffness

    Time frame: the outcome is assessed at week 4

Sponsors and collaborators

Lead sponsor

Ardabil University of Medical Sciences

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
May 1, 2008
Registry last updated
Apr 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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