Study of the Efficacy and Safety of Broncho-munal®, Capsules, 7 mg for the Treatment of Acute Uncomplicated Respiratory Tract Infections

Inclusion Criteria:

• Patient signing and dating of the Patient Information Sheet Informed Consent Form.
• Men and women between the ages of 18 and 60 inclusive at the time of signing thePatient Information Sheet Informed Consent Form.
• Symptoms of acute uncomplicated respiratory tract infection of mild to moderateseverity:
• The presence of two or more symptoms of moderate severity or three or more symptoms ofmild severity according to the WURSS-21 questionnaire
• The presence of two or more symptoms of moderate severity or three or more symptoms ofmild severity according to the CCQ questionnaire
• Body temperature ≥ 37.50 ° C and ≤ 40.0 ° C since the onset of the disease.
• Duration of disease symptoms less than 36 hours prior to randomization.
• The patient's consent to use reliable contraceptive methods throughout the study andfor 3 weeks after its completion. The following may take part in the study: women who have a negative pregnancy test and are using the following contraception: barriermethod (condom or occlusion cap (diaphragm or cervical / vaulted cap)) or dual barriermethod of contraception (condom or occlusive cap (diaphragm or cervical / sperm cap (cid)plus foam / gel / film / cream / suppository)). The study may also include women who areunable to bear children.

(history: hysterectomy, tubal ligation, infertility, menopause for more than 1 year). Or men with safe reproductive function using barrier contraception, as well as men withinfertility or previous vasectomy history.

Exclusion Criteria:

• Aggravated history of allergies, including food allergies
• Intolerance to drugs, incl. hypersensitivity or idiosyncrasy to Broncho-munal® or itsexcipients and to any other product from the concomitant / standard treatment
• A positive result of the analysis performed by the PCR method for the presence ofSARS-CoV-2 RNA at the screening stage.
• Positive result of the analysis performed by Rapid Influenza Diagnostic Test for thepresence of the influenza virus at the screening stage.
• Clinically confirmed of the presence of a new coronavirus infection COVID-19 inaccordance with the regulatory acts of the Ministry of Health of the RussianFederation for the prevention, diagnosis and treatment of a new coronavirus infection (COVID-19), (the version is current at the time of inclusion of patients).
• Any vaccination less than 30 days before screening.
• The presence of any symptom of a severe course of the disease (fever of 40 ° C andhigher, pulse - more than 120 beats / min, SBP - less than 90 mm Hg, muffled heartsounds, NPV - more than 28 per minute, the presence of complications, impairment ofconsciousness, seizures).
• Other infectious diseases less than 14 days before the screening visit, includingthose requiring local and / or systemic antibiotic therapy (cystitis, pyelonephritis,endocarditis, etc.)
• Chronic lung diseases (such as cystic fibrosis, pulmonary emphysema, tracheobchonchialdyskinesia, chronic obstructive pulmonary disease (COPD), bronchiectasis, etc.) in theacute stage.
• Bronchial asthma and chronic bronchitis in history.
• Pulmonary tuberculosis (active or inactive form).
• The use of drugs with immunomodulatory (including Broncho-munal) and / orimmunostimulating and / or immunosuppressive effects, less than 1 month beforescreening.
• The need to use drugs from the list of prohibited therapy.
• Peptic ulcer of the stomach and duodenum or other erosive and ulcerative lesions ofthe gastrointestinal tract in the acute stage.
• Syndrome of malabsorption or other clinically significant disease of thegastrointestinal tract (uncorrected vomiting, diarrhea, ulcerative colitis, andothers).
• Deficiency of the enzyme glucose-6-phosphate dehydrogenase.
• Dehydration, hypovolemia, anorexia, bulimia and cachexia (insufficient supply ofglutathione in the liver) according to the anamnesis at the time of screening.
• Autoimmune diseases, according to anamnesis (systemic lupus erythematosus, rheumatoidarthritis, etc.).
• Uncontrolled diabetes mellitus.
• Syndrome of renal or hepatic insufficiency, confirmed by physical examination data.
• Positive result of any of the following tests: blood test for Hep. B, Hep.C, HIVand/or syphillis.
• Chronic heart failure III - IV functional class according to the functionalclassification of the New York Heart Association (NYHA), including unstableprogressive angina pectoris IV functional class, uncontrolled arterial hypertension,severe arterial hypotension.
• A history of malignant neoplasms.
• Alcohol or drug addiction, history of mental illness.
• Smoking more than 20 cigarettes a day.
• Severe, decompensated or unstable somatic diseases (any diseases or conditions thatthreaten the patient's life or worsen the patient's prognosis, as well as make itimpossible for him to participate in a clinical trial).
• Major surgery, 3 months before screening (associated with a risk to the patient'slife).
• Patient's unwillingness or inability to comply with Protocol procedures (in theopinion of the investigator).
• Taking other medications that, in the Investigator's opinion, may affect the courseand results of the clinical trial.
• Pregnancy or breastfeeding period.
• Participation in other clinical trials at the screening visit or for 30 days beforethe screening visit.
• Other conditions that, in the Investigator's opinion prevent the patient from beingincluded in the research.