The aim of present study is to determine affects of ostrich oil in the treatment of patients with knee osteoarthritis. In a single center randomised double blind clinical trial study controlled with placebo, 90 patients with knee osteoarthritis who referred to Rheumatology clinic of Imam-Reza Hospital of Tabriz University of Medical Sciences will select randomly and with using random numbers table will allocate in two groups of intervention and control group. Inclusion criteria are, age between 45 to 60 years old, knee osteoarthritis based on clinical and radiological criteria, morning stiffness less than 10 minutes, moderate knee osteoarthritis based on radiological criteria, and informed consent form for participating in study. Exclusion criteria are severe knee osteoarthritis, and body mass index more than 30. In intervention group patients will receive ostrich oil 1 cc per knee two times in a day topically for 3 months and in control group patients will receive same amount of placebo.
Patients will follow up for 3 months. Arthralgia is as primary variable of study and side effect is as secondary variable of present study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016080729227N1
Registration date:2016-09-02, 1395/06/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-02, 1395/06/12
Registrant information
Name
Ali Asghar Ebrahimi
Name of organization / entity
Department of Internal Medicine, Tabriz University of Medical Sciences.
Country
Iran (Islamic Republic of)
Phone
+98 41 3541 5023
Email address
ebrahimia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences.
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the affects of ostrich oil in knee joint relief in patients with knee osteoarthritis; a randomised double blind clinical trial study
Public title
Affects of ostrich oil in the treatment of patients with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 45 to 60 years old; knee osteoarthritis based on clinical and radiological criteria; morning stiffness less than 10 minutes; moderate knee osteoarthritis based on radiological criteria; informed consent form for participating in study.
Exclusion criteria: severe knee osteoarthritis; body mass index more than 30.
Age
From 45 years old to 60 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences.
Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz, Eastern Azerbaijan, Iran.
City
Tabriz
Postal code
Approval date
2016-01-04, 1394/10/14
Ethics committee reference number
IR.TBZMED.REC.1395.58
Health conditions studied
1
Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Gonarthrosis
Primary outcomes
1
Description
Knee joint pain
Timepoint
Beginig of study and 3 months later
Method of measurement
Physical examination based on WOMAC questionnaire
Secondary outcomes
1
Description
Adverse effects
Timepoint
3 months later
Method of measurement
Patient follow up
Intervention groups
1
Description
In intervention group: patients will receive ostrich oil 1 cc production of MAM pharmaceutical company per knee two times in a day topically for 3 months.
Category
Treatment - Drugs
2
Description
In control group: patients will receive placebo 1 cc production of MAM pharmaceutical company per knee two times in a day topically for 3 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam-Reza Hospital of Tabriz University of Medical Sciences
Full name of responsible person
Dr Ali Asghar Ebrahimi
Street address
Imam-Reza Hospital of Tabriz University of Medical Sciences, Daneshgah Street, Tabriz, Eastern Azerbaijan, Iran.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences.
Full name of responsible person
Dr Hasan Soleimanpour
Street address
Deputy of Research and Technology, Central Building of Number Two, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences.
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences.
Full name of responsible person
Dr Ali Asghar Ebrahimi
Position
Subspecialty of Rheumatology.
Other areas of specialty/work
Street address
Faculty of Medicine, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3541 5023
Fax
Email
ebrahimia@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences.
Full name of responsible person
Dr Ali Asghar Ebrahimi
Position
Subspecialty of Rheumatology
Other areas of specialty/work
Street address
Faculty of Medicine, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3541 5023
Fax
Email
ebrahimia@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences.
Full name of responsible person
Dr Ali Asghar Ebrahimi
Position
Subspecialty of Rheumatology
Other areas of specialty/work
Street address
Deputy of Research and Technology, Central Building of Number Two, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3541 5023
Fax
Email
ebrahimia@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)