Effect of hydroxychloroquine on symptoms of patients with knee osteoarthritis who will attend to rheumatology clinic of Imam Reza Hospital of Mashhad Mashhad
Aim: The aim of this study is to evaluate the effect of hydroxychloroquine on primary knee osteoarthritis symptoms.
Patients: All patients with primary knee osteoarthritis who will come to Rheumatology Clinic of Imam Reza Hospital of Mashhad.
Inclusion criteria: 1) Knee osteoarthritis according to ACR criteria grade I & II (Kellgren and Lawrence grades) 2) Age 45-65 years
Exclusion criteria: 1) Secondary osteoarthritis 2) Osteoarthritis grade> II 3) History of knee arthroscopy or intra-articular corticosteroid injection during the last 6 months 4) History of hypersensitivity to antimalarial drugs 5) Any eye problem
Sample size: 60 patients
Intervention: oral hydroxychloroquine 200 mg twice daily for 24 weeks
Primary outcome: knee osteoarthritis symptoms
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138709121479N1
Registration date:2008-12-23, 1387/10/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2008-12-23, 1387/10/03
Registrant information
Name
Mohammadhassan Jokar
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 1859 8818
Email address
jokarmh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
The vice Chancellor for Research, Mashhad University for Medical Sciences
Expected recruitment start date
2008-12-21, 1387/10/01
Expected recruitment end date
2009-06-20, 1388/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of hydroxychloroquine on symptoms of patients with knee osteoarthritis who will attend to rheumatology clinic of Imam Reza Hospital of Mashhad Mashhad
Public title
Effect of hydroxychloroquine on symptoms of patients with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1) Knee osteoarthritis according to ACR criteria
2) Knee osteoarthritis grade I & II (Kellgren and Lawrence grades)
3) Age 45-65 years
4) Ability to read and write
Exclusion criteria:
1) Secondary osteoarthritis
2) Osteoarthritis grade> II
3) History of knee arthroscopy during the last 6 months
4) History of intra-articular corticosteroid injection during the last 6 months
5) History of hypersensitivity to antimalarial drugs
6) Any eye problem
Age
From 45 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
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 Mashhad Univrsity for Medical Science
Street address
Mashhad Univrsity for Medical Science, Daneshgah street
City
Mashhad
Postal code
91375-345
Approval date
2008-05-19, 1387/02/30
Ethics committee reference number
87033
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
M17.0 , M1
ICD-10 code description
Primary gonarthrosis, bilateral, Other primary gonarthrosis
Primary outcomes
1
Description
knee osteoarthritis symptpms
Timepoint
every month for 6 months
Method of measurement
WOMAC Index
Secondary outcomes
1
Description
Joint cartilage thickness
Timepoint
At the begining and six months after intervention
Method of measurement
Joint space meaturement
Intervention groups
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Mashhad
Full name of responsible person
Dr Mohammadhassan Jokar
Street address
Internal Medicine Deprtment,Imam Reza Hospital, Mashad, Iran
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The Vice Chancellor for Research, Mashhad University for Medical Sciences
Full name of responsible person
Dr Jalil Tavakkol Afshari
Street address
The Vice Chancellor for Research, Mashhad University for Medical Sciences, Mashhad, Iran
City
Mashhad
Grant name
بودجه پژوهشی
Grant code / Reference number
87033
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Vice Chancellor for Research, Mashhad University for 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
Imam Reza Hospital, Mashhad University for Medical Sciences
Full name of responsible person
Dr Mohammadhassan Jokar
Position
Assistant Professor and subspecialist in rheumatology
Other areas of specialty/work
Street address
Internal Medicine Department, Imam Reza Hospital, Mashhad, Iran
City
Mashhad
Postal code
+98 9137913316
Phone
+98 51 1859 8818
Fax
+98 51 1859 8818
Email
jokarmh@mums.ac.ir
Web page address
www.mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Reza Hospital, Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohammadhassan Jokar
Position
Assistant Professor and subspecialist in rheumatology
Other areas of specialty/work
Street address
Internal medicine Department, Imam Reza Hospital, Mashhad, Iran
City
Mashhad
Postal code
+98 913 7913316
Phone
+98 51 1859 8818
Fax
+98 51 1859 8818
Email
jokarmh@mums.ac.ir mohammadhassan_jokar@yahoo.com
Web page address
www.mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Imam Reza Hospital, Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohammadhassan Jokar
Position
Assistant Professor and subspecialist in rheumatology
Other areas of specialty/work
Street address
Internal Medicine Department, Imam Reza Hospital, Mashhad, Iran
City
Mashhad
Postal code
+98 9137913316
Phone
+98 51 1859 8818
Fax
+98 51 1859 8818
Email
jokarmh@mums.ac.ir
Web page address
www.mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)