Clinical Efficacy of Glucosamine Plus Diacerein Versus Mono-therapy of Glucosamine

Study Overview
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Brief Summary
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The purpose of this study is to compare pain scores, WOMAC total and subscores, actual and change of joint space width and the rate of gastrointestinal side effects at 4, 8, 12, and 24 weeks between dual-therapy of diacerein and glucosamine versus a mono-therapy of glucosamine in OA patients

Conditions
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Osteoarthritis, Glucosamine, Diacerein

Intervention / Treatment
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* Drug: Glucosamine sulfate
* Drug: Diacerein
* Drug: Placebo (for Diacerein)


Participation Criteria
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Eligibility Criteria
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Adult patients age 50 years or older who have been diagnosed as primary or secondary osteoarthritis of the knee base on clinical criteria of American College of Rheumatology Inclusion Criteria: Clinical diagnosis of primary osteoarthritis Mild deformity Clinical (having no varus or valgus deformity, no crepitus) ? Physical examination grade 0 assessed by stress test Radiographic assessment (Kellgrane-lawrance type II-III), a minimum baseline medial tibiofemoral JSW of _2 mm. Willing to participate and provide written informed consent Exclusion Criteria: Non-secondary osteoarthritis Rheumatoid arthritis, inflammatory arthritis (e.g. SLE, Gout), post traumatic osteoarthritis, those who received intra-articular treatment of the signal joint with any product (corticosteroids in the previous 2 months, or glycosaminoglycans/hyaluronic acid in the previous 6 months) or had undergone joint lavage andarthroscopic procedures in the previous 6 months. No contraindication of using diacerein and glucosamine Non-current or ex-users of oral SYSADOA (e.g., glucosamine sulphate, chondroitin sulphate, diacerein, piascledine), anti-depressants, tranquillisers, antacids or antibiotics known hypersensitivity to diacerein, to similar compounds, to the excipients or to paracetamol

Ages Eligible for Study
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Minimum Age: 50 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glucosamine sulfate & Diacerein<br>Glucosamine sulfate (sachet) 1500 mg and Diacerein 50 mg tablet by mouth once daily for 24 weeks | Drug: Glucosamine sulfate<br> <br> * Other names: Viatril-S;Drug: Diacerein<br> <br> * Other names: Artrodar;|
| Active Comparator: Glucosamine sulfate & Placebo<br>Glucosamine sulfate 1500 mg and Placebo (for Diacerein) 50 mg by mouth once daily for 24 weeks | Drug: Glucosamine sulfate<br> <br> * Other names: Viatril-S;Drug: Placebo (for Diacerein)<br>* Sugar pill manufactured to mimic Diacerein 50 mg tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain visual analog scores |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scores |  | 24 weeks | 
| actual and change of joint space width |  | 24 weeks | 
| Rate of gastrointestinal side effects |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Glucosamine sulfate, Diacerein, Randomized controlled trial