Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
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
Key secondary outcomes:
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.