Phase III clinical trial to evaluate the efficacy and safety of a fixed-dose combination of 1000 mg dipyrone monohydrate + 60 mg caffeine + 4 mg chlorpheniramine maleate in improving symptoms of the common cold and flu in adults.
Participants of both sexes, aged between 18 and 60 years.
Be able to understand, agree to participate in the study, comply with procedures, and attend visits, as indicated by signing the informed consent form (ICF) approved by the Ethics Committee.
Present symptoms of nasal obstruction and/or congestion due to the common cold or influenza, with onset within less than 48 hours, with symptoms classified by the participant as moderate to severe on a 4-point scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms).
Must not have used any medication for symptomatic treatment of the condition.
Participants with COVID-19, diagnosed by rapid antigen test and/or RT-PCR for SARS-CoV-2;
Previous contact with individuals diagnosed with COVID-19 within 14 days prior to screening;
Vaccination against influenza and/or COVID-19 within 7 days prior to the study;
Presence of gastrointestinal symptoms and/or dyspnea associated with cold or flu symptoms;
Parallel
dipyrone monohydrate 1000 mg + chlorpheniramine maleate 4 mg + caffeine 60 mg
DrugThe differential of this study is the dosages and reduction of doses per day.
dipyrone monohydrate 500 mg + chlorpheniramine maleate 2 mg + caffeine 30 mg
DrugThe differential of this intervention is the dosages
Placebo
DrugPlacebo
Proportion of participants who show improvement in symptoms of nasal obstruction and/or congestion
Proportion of participants who show improvement in symptoms of nasal obstruction and/or congestion, obtained through the 4-point Likert scale, 3 days after the start of treatment, compared to baseline, between the experimental drug and the comparator drug. For control purposes, this assessment will also be carried out between the experimental drug arm and the placebo.
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