Clinical Trial of Safety and Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Adults
Condition: Acute Upper Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Intervention: Ergoferon; Placebo
Intervention description: 5 ml 3 times a day; 5 ml 3 times a day
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 342.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The purpose of this study is:

        -  to evaluate safety of the liquid dosage form of Ergoferon in the treatment of acute
           upper respiratory tract infections in adults;

        -  to evaluate clinical efficacy of the liquid dosage form of Ergoferon in the treatment of
           acute upper respiratory tract infections in adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients of both genders aged from 18 to 60 years inclusively.

          -  Patients who visited a doctor during the increase of seasonal incidence within 24
             hours after the onset of acute respiratory infection of the upper respiratory tract.

          -  Body temperature ≥37,8°C at the moment of examination by the doctor.

          -  Presence of two or more moderate severity symptoms or three or more mild severity
             symptoms according to the Common Cold Questionnaire (CCQ).

          -  The possibility to start therapy within 24 hours from the onset of the first symptoms
             of acute respiratory infection of the upper respiratory tract.

          -  The use of contraceptive methods by the patients of both the sexes during the study
             and within 30 days after completion of participation in the study.

          -  Availability of signed patient information sheet (Informed Consent form) for
             participation in the clinical trial.

        Exclusion Criteria:

          -  Suspected invasive bacterial infection or the presence of a severe disease requiring
             use of antibacterial drugs (including sulfanilamides).

          -  Suspected initial manifestations of diseases that have symptoms similar to acute URTI
             (other infectious diseases, flu-like symptoms at the onset of systemic connective
             tissue disorders, hematologic neoplasms and other pathologies).

          -  Exacerbated or decompensated chronic diseases affecting a patient's ability to
             participate in the clinical trial.

          -  Oncological diseases.

          -  Medical history of polyvalent allergy.

          -  Allergy/intolerance to any of the components of medications used in the treatment.

          -  Impaired glucose tolerance, diabetes mellitus type 1 and 2.

          -  Hereditary fructose intolerance (due to the presence of maltitol in the study drug).

          -  Use of any medicine listed in the section "Prohibited concomitant treatment" within 30
             days preceding the inclusion in this study.

          -  Pregnancy, breastfeeding.

          -  Consumption of narcotics, alcohol > 2 alcohol units per day.

          -  Patients with mental disorders.

          -  Patients who, from the investigator's point of view, will fail to comply with the
             observation requirements of the trial or with the regimen of the study drugs.

          -  Participation in other clinical studies within 3 months prior to enrollment in the
             current trial.

          -  Other factors, which hinder the patient's participation in the trial (for example,
             planned trips or business trips).

          -  Patients are related to the research staff of the clinical trial site who are directly
             involved in the trial or are the immediate family member of the researcher. The
             immediate family members include husband/wife, parents, children or brothers (or
             sisters), regardless of whether they are natural or adopted.

          -  Patients employed with MATERIA MEDICA HOLDING (i.e., the company's employee, a
             part-time employee under contract, or appointed official in charge of the trial, or
             their immediate family).