Evaluation of Efficacy and Safety of Oral Solution Resfenol in Reducing Symptoms of Common Cold And Flu
Status:
Completed
Trial end date:
2011-11-01
Target enrollment:
Participant gender:
Summary
This study aimed to evaluate the efficacy and safety of the oral solution of paracetamol,
chlorpheniramine maleate and phenylephrine hydrochloride in reducing symptoms of flu and the
common cold. There will be a randomized, double-blind, placebo-controlled trial. Will be
included 216 subjects, male or female, aged greater than 12 and less than or equal to 60
years, irrespective of color and / or race with symptoms of recent onset, for more than 6
hours and less than 48 hours length, characterizing Common Cold and / or Influenza.
After clinical evaluation and laboratory research subjects will be randomized to receive
active drug or placebo, 10 ml oral solution every 6 hours for 48 hours. The follow-up visits
will be held on 2 (24 hours after first intervention) and in 3 days (48 hours after first
intervention).
The outcomes to assess the effectiveness so far consist of the scores of symptoms and to
assess the safety of the drug will be accompanied by the emergence of adverse events.