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Prospective, multicenter, phase IV, open, randomized, parallel, controlled, in which 288 (two hundred and eighty-eight) participants of both sexes, aged between 40 and 75 years will be randomly allocated to one of two treatment groups , and treatment group 01 will be the dried extract of Curcuma longa complexed with phosphatidylcholine (Motore®), and treatment group 02 will ibuprofen (Alivium®).
This study evaluate the efficacy and safety of Dry Extract of Curcuma Longa complexed with phosphatidilcholine (Motore®) Compared to Ibuprofen (Alivium® ) in the treatment of adults with knee osteoarthritis. The study population will consist in participants of both sexes, aged between 40 and 80 years old with a clinical diagnosis of knee osteoarthritis (tibiofemoral joint) based on clinical and radiological criteria (Grades 2 and 3 Kellgren and Lawrence) and who had osteoarthritis symptoms in the last six (06) months preceding the start of the study. They will be randomly allocated to one of two treatment groups , and treatment group 01 will be the dried extract of Curcuma longa complexed with phosphatidylcholine (Motore®), and treatment group 02 will ibuprofen (Alivium®).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motore | Experimental | Curcuma longa complexed with phosphatidylcholine - 250 mg (Motore®), two (02) capsules orally every twelve (12) hours |
|
| Alivium | Active Comparator | Ibuprofen 600 mg (Alivium®), one (01) coated tablet orally, every six (06) hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motore | Drug | 250 mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in the pain domain score of the WOMAC questionnaire | The primary efficacy endpoint will be the reduction in the pain domain score of the WOMAC questionnaire after 42 (forty two) days of treatment | After 42 (forty two) days of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco Rocha, MD | Artroclinica de Fortaleza | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ache Laboratorios Farmaceuticos | Guarulhos | São Paulo | Brazil |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Alivium |
| Drug |
600 mg |
|
|
| D012216 |
| Rheumatic Diseases |