Upper Airway Infections Clinical Trial
Official title:
Randomized , Placebo-controlled, Clinical Trial of Efficacy and Safety Evaluation of Guaifenesin, Doxylamine Succinate and Hydrochloride Etafedrine Syrup in Improving the Signs and Symptoms of Infections of Way Upper (URI)
Evaluate the improvement of the common cold with the use of medication
Patients with signs and symptoms of URI will be forwarded to the Research Center for a
screening in which the researchers will select those meet the inclusion criteria. This visit
will be informed of the objectives study, methodology, risks and benefits, the right of
patients to give up research, the confidentiality of data and other details that provide the
the patients to consider their participation basement viable or not. All aspects relevant to
the consideration of the patient on their participation will described in the Informed
Consent, which will be read and signed before any procedure. The patients included are
randomized, open treatment immediately and will be sent to perform a radiological
examination (Rx - sinus of the face). This examination used to detect other clinical
pictures than URI. After 24 hours (visit 02), the patient will return for the assessment and
clinical questions about their symptoms, which provide the scores of efficacy of the
product. This visit will review the radiological examination, and on the finding that
infection of sinuses without symptoms, the patient will excluded because of antibiotic use
will begin. In return for three days (visit 03), patients will again evaluated in relation
to their clinical status. On this visit, the doctor may take the following behaviors:
- Patients who have no clinical symptoms get high.
- Patients who have not improved, take a dose of medicine increased.
- The worsening of the present that, due to infections bacterial or other clinical
pictures, will be excluded and referred to a general practitioner employed by the
sponsor. In return for seven days, patients should return the products and again
participate in a clinical consultation, in which researchers may take the following
behaviors:
- Patients who have no clinical symptoms get high.
- Patients who have not improved or have worsened will be exempted from study and
referred to the general practitioner hired by the sponsor is repeated for the diagnosis
and establish a new treatment. Will be allowed the use of rescue medications such as
paracetamol or sodium dipyrone, justified by the existence of the placebo group and
those products do not interfere in the results evaluated, it was a pain and
antipyretics.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment