Phase III Study of a Combination Drug with Dipyrone, Caffeine, and Chlorpheniramine to Improve Common Cold and Flu Symptoms in Adults

What this Trial Is About

This trial investigates how well a fixed-dose combination of dipyrone monohydrate, caffeine, and chlorpheniramine maleate works to improve symptoms of the common cold and flu in adults aged 18 to 60 years. The study evaluates the safety and effectiveness of this combination compared to an active comparator and a placebo in adults experiencing nasal obstruction and congestion. It aims to provide insight into symptom relief within a few days of treatment. Participants are randomly assigned to one of three groups one receiving 1000 mg dipyrone monohydrate with 60 mg caffeine and 4 mg chlorpheniramine maleate, another receiving a lower dose of these drugs, or a placebo group. The study is double-blind, so neither participants nor researchers know which treatment is given. The treatments are administered as fixed-dose tablets, and the trial is designed to compare the different doses impact on symptom improvement. During the study, participants attend visits where researchers monitor symptoms of nasal obstruction and congestion over three days. They assess how many participants show improvement and record any safety concerns. Participants must comply with study procedures, including not having used other symptomatic treatments and following visit schedules. The total participation period lasts until the primary outcome is assessed at three days after treatment begins, with safety and symptom monitoring throughout.

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