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

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Piroxicam
Olive Oil
Sponsored by
Ardabil University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring osteoarthritis, Knee, virgin olive oil, piroxicam, Topical

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

  • ArdabiUMS clinic of rheumatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

P (Pircoxicam Group)

O (olive oil group)

Arm Description

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.

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.

Outcomes

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 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 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 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 Measures

the secondary measure will be changes in stiffness
the secondary measure will be changes in stiffness
the secondary measure will be changes in stiffness
the secondary measure will be changes in stiffness

Full Information

First Posted
April 29, 2008
Last Updated
April 28, 2010
Sponsor
Ardabil University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00670475
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ardabil University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
osteoarthritis, Knee, virgin olive oil, piroxicam, Topical

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
P (Pircoxicam Group)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
O (olive oil group)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Piroxicam
Other Intervention Name(s)
Piroxicam topical gel
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Olive Oil
Other Intervention Name(s)
Topical virigin olive oil
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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 Outcome Measure Information:
Title
the secondary measure will be changes in stiffness
Time Frame
the outcome is assessed at week 1
Title
the secondary measure will be changes in stiffness
Time Frame
the outcome is assessed at week 2
Title
the secondary measure will be changes in stiffness
Time Frame
the outcome is assessed at week 3
Title
the secondary measure will be changes in stiffness
Time Frame
the outcome is assessed at week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
shahab bohlooli, PhD
Organizational Affiliation
Pharmacology Dept, Faculty of Medicine, ArdabilUMS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marina Jastan, MD
Organizational Affiliation
rheomatology clinic, faculty of medicine, ArdabilUMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
ArdabiUMS clinic of rheumatology
City
Ardabil
ZIP/Postal Code
56197
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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