NCT00805519

Efficacy and Safety of Prednisolone and Chloroquine Add on Therapy in Osteoarthritis of the Knee

Efficacy and Safety of Prednisolone and Chloroquine Add on Therapy in Osteoarthritis of the Knee Treated With Fixed Dose Combination of Glucosamine and Chondroitin Sulfate.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Ardabil University of Medical Sciences · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	Glucosamine and chondroitin sulfate	In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients, daily.
DRUG	glucosamine and chondroitin sulfate plus Prednisolone	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
DRUG	Glucosamine and Chondroitin sulfate plus Chloroquine	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.
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 as baseline therapy, daily. also,the patients will receive prednisolone 5 mg/day and chloroquine 150 mg every two days.

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2008-12-09
• Last updated: 2010-04-30

Locations

1 site across 1 country: Iran