A Phase 4 interventional study of Glucosamine and chondroitin sulfate and glucosamine and chondroitin sulfate plus Prednisolone in Osteoarthritis of the Knee, sponsored by Ardabil University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2010-04-30.
Sponsored by Ardabil University of Medical Sciences · Phase 4, Interventional, and Treatment
This study was conducted to evaluate the efficacy and safety of prednisolone and chloroquine add on therapies to combined glucosamine, chondroitin sulfate in osteoarthritis of the knee which will be done in contrast to combined glucosamine sulfate and chondroitin.
Fixed dose glucosamine, chondroitin sulfate combination is a treatment to osteoarthritis with some controversy about efficacy. it seems that addition of other agents may improve efficacy and decrease the required dose and cost. common oral corticosteroids such as low dose prednisolone and chloroquine are candidate for such add on therapies. nevertheless, add on therapy may expose the patients to new side effects which should followed and addressed.
In this investigator blinded controlled trial, 240 patients with diagnosed osteoarthritis of knee will be enrolled to the study. the patients will randomly be assigned to one of four groups of G (glucosamine and chondroitin sulfate ), P (Glucosamine and Chondroitin sulfate plus Prednisolone), C (Glucosamine and Chondroitin sulfate plus Chloroquine) and PC (Glucosamine and Chondroitin sulfate plus Prednisolone and Chloroquine). each group will consist 60 patients. the investigator(s) will be blind to the groups and interventions.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 230 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Ardabil University of Medical Sciences is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
in this group patients will receive Glucosamine and chondroitin sulfate oral dietary supplementation
Drug: Glucosamine and chondroitin sulfate
in this group patients will receive glucosamine and chondroitin sulfate plus Prednisolone oral administration
Drug: glucosamine and chondroitin sulfate plus Prednisolone
in this group pateints will orally receive Glucosamine and Chondroitin sulfate plus Chloroquine.
Drug: Glucosamine and Chondroitin sulfate plus Chloroquine
in this group patients will receive Glucosamine and Chondroitin sulfate plus Prednisolone and Chloroquine
Drug: Glucosamine,Chondroitin sulfate,Prednisolone,Chloroquine
In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients, daily.
In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients as baseline therapy, daily. also,the patients will receive Prednisolone 5 mg/day
In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients as baseline therapy, daily. also,the patients will receive chloroquine 150 mg every two days.
In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients as baseline therapy, daily. also,the patients will receive prednisolone 5 mg/day and chloroquine 150 mg every two days.
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: Baseline
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 6 weeks after baseline visit
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 12 weeks after baseline visit
The secondary measure will be changes in stiffness
Time frame: the outcome is assessed at baseline visit
The secondary measure will be changes in stiffness
Time frame: the outcome is assessed at 6 weeks after baseline visit
The secondary measure will be changes in stiffness
Time frame: the outcome is assessed at 12 weeks after baseline visit
This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.
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Ardabil University of Medical Sciences