Effectiveness of Glucosamine + Chondroitin in Osteoarthrosis

Study Overview
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Brief Summary
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This study objective is to check the non-inferiority of the 2 formulations produced by EMS when compared with the same substances and pharmaceuticals forms of the product Condroflex (Zodiac), by promoting the relief of osteoarthrosis symptoms such as pain, stiffness and functional capacity that will be periodically measured by using the Visual Analog Scale of pain (VAS) and the questionnaire of Lequesne.

Official Title
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Randomized Study of Two Dosage Forms (Oral Powder and Capsule) of Chondroitin + Glucosamine Sulfate Produced by the Laboratory EMS When Compared to the Product Condroflex (Oral Powder and Capsules) Produced by Laboratory Zodiac in the Treatment of Osteoarthrosis.

Conditions
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Osteoarthrosis

Intervention / Treatment
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* Dietary Supplement: EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder)
* Dietary Supplement: EMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)
* Dietary Supplement: Zodiac: Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (Oral powder)
* Dietary Supplement: Zodiac Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who agree with all aspects of the study and sign the Informed Consent; Patients of both sexes; Age above 30 years; Clinical and radiological diagnosis of osteoarthritis; Osteoarthritis in grades 1-2; Patients who are conducting medical treatment and that, for trial of Investigator, is eligible for the study. Exclusion Criteria: Patients with a history of trauma clinically significant; Patients who underwent surgery on joints affected; Coexistence of diseases that might impede the successful conclusion of the trial (rheumatism and others); Pregnant patients and / or breastfeeding; Patients with phenylketonuria; Patients with clinical diagnosis of severe renal failure; Patients with clinical diagnosis of severe liver disease; Patients with clinical diagnosis of clotting disorders; Patients who are being treated with anti-aggregating and / or anticoagulants; Patients with sensitive components of the formula; Patients with emotional disorders that interfere with the capture of data; Patients who do not agree with the purposes of the study and did not sign the Informed Consent.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test 1<br>Oral Powder EMS | Dietary Supplement: EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder)<br>* Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg<br>|
| Experimental: Test 2<br>Hard Capsules EMS | Dietary Supplement: EMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)<br>* Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg<br>|
| Active Comparator: Comparator 1<br>Oral Powder Zodiac | Dietary Supplement: Zodiac: Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (Oral powder)<br>* Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg<br>|
| Active Comparator: Comparator 2<br>Hard capsules - Zodiac | Dietary Supplement: Zodiac Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)<br>* Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in pain. |  | V0 (Screening); V1 (Inclusion); V2 (2 weeks); V3 (4 weeks); V4 (8 weeks); V5 (12 weeks); V6 (24 weeks). |