Abexol + Prevenox in Osteoarthritis

Category Primary study
Registry of TrialsRegistro Público Cubano de Ensayos Clínicos
Year 2013
INTERVENTION: Control Group. 1 Placebo tablet of Abexol + 2 Placebo Tablets of Prevenox, by oral route, at breakfast for 6 weeks Study Group 1. 1 tablet of Abexol (50 mg) + 2 Placebo Tablets of Prevenox, by oral route, at breakfast for 6 weeks Group Study 2. 1 Placebo tablet of Abexol + 2 tablets of Prevenox (5 mg), by oral route, at breakfast for 6 weeks Study Group 3. 1 tablet of Abexol (50 mg) + 2 tablets of Prevenox (5 mg), by oral route, at breakfast for 6 weeks CONDITION: Osteoarthritis PRIMARY OUTCOME: Health Status (WOMAC questionnaire 0‐Best Score between health status and 96‐worst health status). Measuring Time: Before starting treatment and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks SECONDARY OUTCOME: Pain (WOMAC questionnaire. Value between 0 and 20 points). Measuring time: at baseline and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks Stiffness (WOMAC questionnaire. Value from 0 to 8 points). Measuring time: at baseline an at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks. Physical Activity Survey (WOMAC questionnaire. Value between 0 and 68 points). Measuring time: at baseline and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks. Pain (visual scale by analogy. Value between 0‐no pain, 100‐worst pain imaginable). Measuring time:at baseline and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks Physical exam (Weigth (kg), Blood presure (mm Hg), Cardiac frequency (Pulse por minute)). Measuring time: at baseline and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks. Blood biochemical parameters (alanine amino transferase (ALT) (U / L), aspartate aminotransferase (AST) (U / L), glucose (mmol / L), creatinine (umol / L), total cholesterol (mmol / L) , Triglycerides (mmol / L)). Measuring time: at baseline and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks. Adverse Events (AE). Description of the AE (name of the event) Intensity of AE(Mild, Moderate, Severe) Relationship (WHO scale‐ Very probable, Probable, Possible, Remote, Not related, Unknown). Measuring time: At the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks. INCLUSION CRITERIA: The sample will be made up of: 1. Women and men. 2. Ages between 20 and 80 years. 3. With symptoms of OA (joint pain in hip, spine, limbs and / or phalanges). 4. Which have agreed to give informed consent. 5. Patients classified in Scales I‐III of the American Association of Rheumatology. 6. Patients with WOMAC score >= 25.
Epistemonikos ID: f7ce9926eec4c2e991ca2944295e709d2efaef17
First added on: Aug 22, 2024