Osteoarthritis of the Knee
Conditions
Keywords
Osteoarthritis of the Knee, Glucosamine Chondroitin sulfate, Prednisolone, Chloroquine
Brief 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.
Interventions
DRUGGlucosamine and chondroitin sulfate
In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients, daily.
DRUGglucosamine 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
DRUGGlucosamine 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.
DRUGGlucosamine,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.
Sponsors
Ardabil University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* men and non-pregnant women, age 40-85 years with primary OA of at least one knee.
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: * oral corticosteroid within the previous 14 days * intramuscular corticosteroid within 30 days * intraarticular corticosteroid into the study knee within 90 days * intra-articular corticosteroid into any other joint within 30 days or * topical corticosteroid at the site of application within 14 days * ongoing use of prohibited medication including NSAID, other oral analgesic, muscle relaxant, or low-dose antidepressant for any chronic pain management * glucosamine or chondroitin within the previous six months * history of alcohol or drug abuse * lactation * concomitant skin disease at the application site * current application for disability benefits on the basis of knee osteoarthritis; fibromyalgia; other painful or disabling condition affecting the knee
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | Baseline |
Secondary
| Measure | Time frame |
|---|---|
| The secondary measure will be changes in stiffness | the outcome is assessed at baseline visit |
Countries
Iran
Outcome results
None listed