Efficacy and Safety of Paracetamol, Chlorpheniramine and Phenylephrine in the Treatment of Common Cold and Flu Syndrome
Status:
Completed
Trial end date:
2009-11-01
Target enrollment:
Participant gender:
Summary
The aim of this study is to evaluate the efficacy and safety of a fixed combination of
paracetamol, phenylephrine and chlorpheniramine in symptomatic treatment of common cold and
flu-like illness in adults in a randomized, double-blind, controlled trial. The investigators
included 146 healthy study subjects aged between 18 and 60 years who presented flu or common
cold moderate to severe onset of less than 3 days (72 hours). After clinical and laboratory
evaluation were randomized to receive active drug or placebo, five capsules a day, every 4
hours for 48-72h.The outcomes to assess the effectiveness involve the measurement of symptom
scores, overall duration of symptoms, return to usual activities, use of rescue medication,
improvement of the fever.