A total of 60 subjects with symptoms of mild to moderate OA were selected and recruited into the study. Each subject was randomly assigned to the treatment group or placebo group using a randomization table generated using validated computer software CODE; IDV, Gauting, Germany. The randomization codes were secured confidential by the clinical trial pharmacist and statistician. Thirty subjects were allocated each into placebo and Aflapin groups. The subjects in Aflapin group received 50 mg of encapsulated Aflapin ® twice daily, whereas, the subjects in the placebo group received two capsules having similar organoleptic properties including weight, taste, color, odor and feel. Each subject filled a questionnaire, providing details regarding demographics, medical history and nutritional status, at the baseline evaluation and during each follow-up evaluation on days 5, 15 and 30.
No comments:
Post a Comment