Comparison of two-drug regimen of Glucosamine sulfate and Prednisolone with one-drug regimen of Glucosamine sulfate in treatment of knee osteoarthritis
Objective: This study was conducted to compare the clinical efficacy of two-drug regimen of glucosamine and prednisolone with one-drug regimen of glucosamine in treatment of knee osteoarthritis.
Methods: In this randomized clinical trial, 30 patients received glucosamine and prednisolone (case group) and 25 cases underwent treatment by only glucosamine (control group) for 12 weeks. Inclusion criteria: Chronic pain due to osteoarthritis, Knee cryptation, osteophytes and subchondral sclerosis in radiography, Normal CRP and ESR Exclusion criteria: treatment with NSAIDs, history of trauma, other rheumatologic disorders, diabetes, Hypertension, Knee replacement, immuno depressant. To assess pain and disability, WOMAC (Western Ontario and McMaster Universities) was used.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138803242032N1
Registration date:2010-11-08, 1389/08/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-11-08, 1389/08/17
Registrant information
Name
Farhad Pourfarzi
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3325 9011
Email address
f.pourfarzi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
private
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2009-09-21, 1388/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two-drug regimen of Glucosamine sulfate and Prednisolone with one-drug regimen of Glucosamine sulfate in treatment of knee osteoarthritis
Public title
Comparison of two-drug regimen of Glucosamine sulfate and Prednisolone with one-drug regimen of Glucosamine sulfate in treatment of knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Chronic pain due to osteoarthritis, Knee cryptation, osteophytes and subchondral sclerosis in radiography, Normal CRP and ESR
Exclusion criteria: treatment with NSAIDs, history of trauma, other rheumatologic disorders, diabetes, Hypertension, Knee replacement, immuno depressant
Age
From 45 years old to 84 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
55
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences
Street address
Ardabil - Ardabil University of Medical Sciences
City
Ardabil
Postal code
Approval date
empty
Ethics committee reference number
6586
Health conditions studied
1
Description of health condition studied
Osteoartheritis
ICD-10 code
M19.9
ICD-10 code description
Arthrosis, unspecified
Primary outcomes
1
Description
pain
Timepoint
week 6 and 12
Method of measurement
WOMAC
Secondary outcomes
1
Description
Movement limitation
Timepoint
week 6 and 12
Method of measurement
WOMAC
Intervention groups
1
Description
glucosamine and prednisolone (case group)
Category
Treatment - Drugs
2
Description
only glucosamine (control group)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ardabil Imam khomeini hospital
Full name of responsible person
Farhad Pourfarzi
Street address
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mehrdad Mirza Rahimi
Street address
Ardabil - Ardabil University of Medical Sciences
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Farhad Pourfarzi
Position
Academic member, Assistant professor
Other areas of specialty/work
Street address
Ardabil University of Medical Sciences
City
Ardabil
Postal code
Phone
+98 45 1552 2080
Fax
Email
f.pourfarzi@arums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Farhad Pourfarzi
Position
Academic member, Assistant professor
Other areas of specialty/work
Street address
Ardabil University of Medical Sciences
City
Ardabil
Postal code
Phone
+98 45 1552 2080
Fax
Email
f.pourfarzi@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)