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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Drug: Glucosamine and chondroitin sulfate
* Drug: glucosamine and chondroitin sulfate plus Prednisolone
* Drug: Glucosamine and Chondroitin sulfate plus Chloroquine
* Drug: Glucosamine,Chondroitin sulfate,Prednisolone,Chloroquine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glucosamine and chondroitin sulfate<br>in this group patients will receive Glucosamine and chondroitin sulfate oral dietary supplementation | Drug: Glucosamine and chondroitin sulfate<br>* In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients, daily.<br>|
| Experimental: P :glucosa, chondroitin, Prednis<br>in this group patients will receive glucosamine and chondroitin sulfate plus Prednisolone oral administration | Drug: glucosamine and chondroitin sulfate plus Prednisolone<br>* 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<br>|
| Experimental: Glucosa, Chondroitin, Chloroquine<br>in this group pateints will orally receive Glucosamine and Chondroitin sulfate plus Chloroquine. | Drug: Glucosamine and Chondroitin sulfate plus Chloroquine<br>* 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.<br>|
| Experimental: Glucosa, Chondro, Prednis,Chloroq<br>in this group patients will receive Glucosamine and Chondroitin sulfate plus Prednisolone and Chloroquine | Drug: Glucosamine,Chondroitin sulfate,Prednisolone,Chloroquine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| 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) |  | 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) |  | the outcome is assessed at 12 weeks after baseline visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary measure will be changes in stiffness |  | the outcome is assessed at baseline visit | 
| The secondary measure will be changes in stiffness |  | the outcome is assessed at 6 weeks after baseline visit | 
| The secondary measure will be changes in stiffness |  | the outcome is assessed at 12 weeks after baseline visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis of the Knee, Glucosamine Chondroitin sulfate, Prednisolone, Chloroquine