Evaluation of Efficacy and Safety of Oral Solution Resfenol in Reducing Symptoms of Common Cold And Flu

This is an interventional treatment trial for Common Cold focused on measuring reducing symptoms, events, Common Cold, flu syndrome, Symptomatic treatment of the Common Cold and Flu syndrome Read More

Inclusion Criteria:

• Men or women older than 12 years and less than or equal to 60 years, without distinction of color and / or race.
• Presenting symptoms of recent onset, for more than 6 hours and less than 48 hours, characterizing one of the following conditions:

Common cold, which consists of at least 3 symptoms among the 10 following: sneezing, rhinorrhea, nasal congestion, headache, muscle pain, discomfort in the throat, sore throat, dysphonia, cough, fever, and these moderate or severe by a scale of severity of symptoms of 4 points (0 = none, 1 = mild, 2 = moderate, 3 = severe),

OR

Flu-like symptoms consisting of fever of at least 38.1 ° C and headache of moderate or severe or myalgia / arthralgia moderate or severe using a scale of severity of symptoms of 4 points (0 = none, 1 = mild, 2 = moderate, 3 = severe).

• Adequate contraception, a woman of childbearing age.
• Do not use any other drugs for the treatment of clinical symptoms, except in cases of urgency, and immediate notification to the investigator. Patients with chronic diseases being treated with monotherapy, stable over the last three months, may be included after medical evaluation.
• Good ability of understanding and cooperation.
• Agreement with the informed consent consent (IC).

• Assessment exams, the medical criteria:

  • Pregnancy test (rapid urine), a woman of childbearing age, performed prior to inclusion;
  • 12-lead electrocardiogram performed during the consultation
  • Complete blood count and platelet count, serum creatinine, serum urea, serum sodium, serum potassium, total bilirubin and fractions, gamma-glutamyltransferase, alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), prothrombin time , amylase, blood glucose (if possible in eight hours of fasting), TSH, urinalysis I, chorionic gonadotropin (β-HCG)

Exclusion Criteria:

• Pregnant or lactating women
• Known hypersensitivity to components of the formula of the drug solution active
• Use of alcohol or illicit drug use
• Use of monoamine oxidase (MAO) or barbiturates
• Diagnosis of allergic rhinitis or perennial activity
• Presenting the diagnosis of any disease or active acute exacerbated chronic disease (not compensated), including hypertension, ischemic heart disease, narrow-angle glaucoma, symptomatic prostatic hyperplasia, chronic renal failure, liver diseases, infectious tracheobronchitis presumably bacterial pneumonia, streptococcal pharyngitis , asthma or chronic obstructive pulmonary disease and any disease or condition that in the opinion of the investigator can modify the results of their study is not due to the drug under investigation or that puts the patient at significant risk
• Clinical evidence of immunosuppression (AIDS, hematologic malignancies, use of immunosuppressive drugs and others)
• Patients who received influenza vaccine for the week before inclusion;
• Patients who in the opinion of the attending physician and / or the investigator may need to receive antiviral drugs for treatment of infection with influenza virus A or B (eg, amantadine, rimantadine, oseltamivir, zanamivir)
• Patients who in the opinion of the attending physician and / or the investigator need receive antibacterial drugs for the treatment of acute respiratory infection
• Drug use prior to inclusion by time less than two dose ranges of these drugs (in the case of associations, considered as the reference half-life longer): analgesics, NSAIDs, glucocorticoids and other immunosuppressants, antihistamines, decongestants topical and systemic, as well as any medications that in the opinion of the investigator can modify the results of their study is not due to the drug under investigation or that the interaction place the patient at significant risk
• Having participated in another clinical research for less than a year.