Efficacy and Safety Assessment of an Anti-Cold Preparation in the Symptomatic Treatment of Common Cold and Flu-Like Syndrome

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to assess the efficacy and safety of an anti-cold preparation 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hospital de Clinicas de Porto Alegre
• Treatments: Acetaminophen; Chlorpheniramine; Oxymetazoline; Phenylephrine

Criteria

Inclusion Criteria:

• Age between 18 to 60 years old;

• Presenting with at least 6 and at max 72 hours of common cold symptoms (headache, muscle ache, rhinorrhea, nasal obstruction, sneezing, cough, sore or irritated throat, hoarseness, fever) or flu-like syndrome (high fever, muscle or articular ache, headache), with at least two symptoms rated by the patient as moderated to severe in an 0 to 4 scale;

• Proper anticonception, in the case of women in fertile age;

• Possibility to abstain from using any other drug for the treatment of the studied condition, except in emergencies, in wich case the responsible party must be immediately notified;

• Cooperation and understanding skills;

• Agreement to informed consent form.

Exclusion Criteria:

• Pregnant or lactating women;

• Hypersensitivity to any of the drug's components;

• Alcohol or substance abuse;

• Use of MAO inhibitor or barbituric;

• Diagnosis of any acute disease in current activity or uncontrolled chronic disease;

• Clinical evidence of immunosuppression;

• Influenza vaccine less than a week prior to inclusion;

• Need for antibiotic treatment for the respiratory infection, in the opinion of the investigator;

• Having participated in other clinical trial less than one year prior to inclusion.