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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test 1 | Experimental | Oral Powder EMS |
|
| Test 2 | Experimental | Hard Capsules EMS |
|
| Comparator 1 | Active Comparator | Oral Powder Zodiac |
|
| Comparator 2 | Active Comparator | Hard capsules - Zodiac |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder) | Dietary Supplement | Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg |
|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lal Clinica Pesquisa E Desenvolvimento Ltda | Valinhos | São Paulo | 13270000 | Brazil |
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| EMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules) | Dietary Supplement | Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg |
|
| Zodiac: Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (Oral powder) | Dietary Supplement | Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg |
|
| Zodiac Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules) | Dietary Supplement | Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg |
|
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D005944 | Glucosamine |
| D011208 | Powders |
| D006244 | Hardness |
| ID | Term |
|---|---|
| D006595 | Hexosamines |
| D000606 | Amino Sugars |
| D002241 | Carbohydrates |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D055595 | Mechanical Phenomena |
| D055585 | Physical Phenomena |
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