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The use of chondroitin sulfate and glucosamine sulfate has been recognized since the 70 decade in the treatment of osteoarthritis. Numerous clinical trials have demonstrated the therapeutic properties of this association in control of osteoarthritis, especially in reducing pain and improving movement. The combination of chondroitin sulfate with glucosamine sulfate offers a significantly higher tolerance than most drug treatments and, moreover, has long lasting effects even after stopping treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chondroitin Sulfate + Glucosamine sulfate | Experimental | Pharmaceutical form capsule. |
|
| Chondroitin Sulfate + Glucosamine Sulfate | Experimental | Oral powder. |
|
| Condroflex® | Active Comparator | Pharmaceutical form capsule. |
|
| CONDROFLEX® | Active Comparator | Oral powder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chondroitin sulfate + Glucosamine sulfate | Drug | 1 capsule three times daily, preferably in the same period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Promotion of pain relief in patients with osteoarthritis. | Assessment of noninferiority clinical association Chondroitin + glucosamine in dosage forms and oral powder hard gelatin capsule, produced by Geolab Pharmaceutical Ltd., with the comparator drugs in the same dosage forms produced by the Laboratory Zodiac (Condroflex ®) through the promotion of pain relief in patients with osteoarthritis between grades 1 and 3, according to the classification of Kellgreen & Lawrence (1957), measured by visual analogue scale (VAS). There will be five visits: V0, V1, V2, V3 and V4. | 4 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional capacity, overall assessment of clinical improvement, assessment of adverse events | Are the secondary objectives:
|
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Constitute the criteria for inclusion in the study:
Constitute the criteria for exclusion from the study:
Use of corticosteroids orally or intramuscularly, fast action, for up to two weeks before V-1 or 14 days before the scheduled visits Use of oral corticosteroids or intramuscular depot for up to 4 weeks before V-1 or 14 days before the scheduled visits the administration of intra-articular corticosteroids in the study joint in the 3 months prior to randomization visit (V0) or during the study the administration of intra-articular corticosteroid into any other joint for up to 4 weeks prior to randomization visit (V0) or during the study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rosa Marcolino Sergio, Doctor | Contact | +551938293822 | sergiomarcolino@uol.com.br |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D002809 | Chondroitin Sulfates |
| D005944 | Glucosamine |
| ID | Term |
|---|---|
| D002807 | Chondroitin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Chondroitin sulfate + Glucosamine sulfate | Drug | 1 sachet per day of the drug dissolved in a beaker with 200 mL water. |
|
| 4 months. |
| D006595 |
| Hexosamines |
| D000606 | Amino Sugars |