Clinical Trial of Clinical Efficiency and Safety of Ergoferon in Treatment of Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Ergoferon; Oseltamivir
Intervention description: Safety and Efficiency of Ergoferon in treatment of Influenza; Safety and Efficiency in treatment of Influenza
Intervention MeSH terms: Oseltamivir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 161.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The purpose of this study is:

        -  to assess clinical efficiency of Ergoferon for treatment of influenza

        -  to assess safety of Ergoferon for treatment of influenza

        -  to compare efficiency of Ergoferon and Tamiflu for treatment of influenza
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients of both sexes aged from 18 to 60 inclusively.

          2. Patients with body temperature >37,8°C at the moment of examination by the doctor;
             with at least one catarrh symptom (cough, rhinitis, sore throat) and one intoxication
             symptom (myalgia, fever/hyperhidrosis, malaise, weakness, headache) during seasonal
             influenza morbidity.

          3. Diagnosed influenza confirmed by express diagnostics (presence of antigens of
             influenza virus in nasal passages epithelium and proved by QuickVue immunological
             test).

          4. The possibility to start therapy within 24 hours after the onset of the first
             influenza symptoms.

          5. Signed Informed Consent form for participation in the study.

        Exclusion Criteria:

          1. Patients aged below 18 years and above 60 years.

          2. Suspected invasive bacterial infection or presence of severe disease requiring use of
             antibacterial drugs (including sulfanilamides).

          3. Vaccination against influenza prior to epidemic season onset.

          4. Medical history of polyvalent allergy.

          5. Allergy/ intolerance to any of the components of medications used in the treatment.

          6. Exacerbation or decompensation of chronic diseases affecting the patient's ability to
             participate in the clinical trial.

          7. Chronic renal insufficiency.

          8. Intake of medicines listed in the section "Prohibited concomitant treatment" for 15
             days prior to the inclusion in the trial.

          9. Pregnancy, breast feeding, unwillingness to keeping to contraception method during the
             study.

         10. Drug addiction, alcohol usage in the amount over 2 units of alcohol per day.

         11. Patients, who from investigator's point o view, will fail to comply with the
             observation requirements of the trial or with the intake regimen of the investigated
             medicines.

         12. Participation in other clinical trials in the course of 1 month prior to the inclusion
             in the trial.

         13. The patient is related to the research personnel of the investigative site, who are
             directly involved in the trial or are the immediate relative of the reseacher. The
             immediate relatives includes husband / wife, parents, children, brothers (or sisters),
             regardless of whether they are natural or adopted.

         14. The patient works for OOO "NPF "Materia Medica Holding" (i.e. is the company's
             employee, temporary contract worker or designated official responsible for carrying
             out the research) or the immediate relative.