• Symptom improval assessed by questionnaires concerning headache, muscle ache, rhinorrhea, nasal obstruction, sneezes, cough, sore or irritated throat, hoarseness and fever, rated by patient himself in a scale from 0 to 4, being 0-absence and 4-severe. [ Time Frame: Questionnaires were answered at baseline and 1st followup to the investigator and during treatment at every dose, 5 times a day, from day 1 to 3/4, through patient's diary. ] [ Designated as safety issue: No ]
  

• Global duration of symptoms, assessed by the investigator through direct questioning at followup visits. [ Time Frame: Day 3/4 and, if no relief yet, day 10/11. ] [ Designated as safety issue: No ]
  
• Time of return to usual activities, such as work or gym, assessed by the investigator through direct questioning at followup visits. [ Time Frame: Day 3/4 and, if no relief yet, day 10/11. ] [ Designated as safety issue: No ]
  
• Use of co intervention for symptom relief during treatment, registered by the volunteer in patient diary, with day and hour of ingestion. [ Time Frame: Assessed during treatment (day 1 to 3/4) by patient diary and questioned by investigator at 1st followup visit. ] [ Designated as safety issue: No ]
  
• Improval of fever by reduction of axillary temperature to less than 38,1°C. [ Time Frame: Assessed by investigator at baseline and 1st followup visit and by patient (with termometer provided by the study) along with every dose, 5 times a day, from day 1 to 3/4, registered in patient diary. ] [ Designated as safety issue: No ]
  
• Adverse effect appearance during and until 7 days after treatment, assessed through patient's report in the diary or followup visit, through physical evaluation at followup and by laboratory exams. [ Time Frame: Days 1 to 3/4 through patient diary, and followup at days 3/4 an 10/11. ] [ Designated as safety issue: Yes ]
  

Upper respiratory infections are rather frequent in the population, and their treatment consists, in most cases, in the use of symptomatic drugs. Acetaminophen is widely used as an analgesic and antipyretic, whereas chlorpheniramine is an antihistaminic and phenylephrine is a vasoconstrictor with decongestioning activity. The aim of this study is to assess the efficacy and safety of an anti-cold preparation, currently commercialized in Brazil by the name Resfenol, compounded by acetaminophen, chlorpheniramine and phenylephrine for the treatment of cold and flu symptoms in healthy individuals in a randomized, double-blind, placebo-controlled clinical trial.

Healthy volunteers are recruited through panels fixated at Hospital de Clínicas de Porto Alegre, in Brazil, and must answer a screening questionnaire at first contact. One hundred and forty six patients who met the inclusion criteria were included and, after baseline clinical and laboratory evaluation, were randomized to receive either the active intervention or placebo, 5 times a day, at 4 hour intervals, during 48 to 72 hours, depending on patient availability to show up for re-evaluation. Patients also received acetaminophen as a co intervention, to be taken only in case of persisting symptoms.

Patients answered, during treatment, several symptom questionnaires contained in a diary, and followup was performed at days 3 or 4 (clinical and laboratory evaluation) and 10 or 11 (clinical followup). Axillary temperature was assessed along with every dose with a thermometer provided by the study and registered in the diary.

Primary endpoint consists in the mean symptom scores, assessed through questionnaires in patient diary, baseline and followup. Secondary endpoints are global duration of symptoms, time of return to usual activities, use of co intervention for symptom relief, improval of fever and adverse effect evaluation.