Study to Evaluate the Efficacy and Safety of Different Doses of Graminidin With Anesthetic, a Metered Dose Topical Spray, in the Treatment of Acute Infectious and Inflammatory Pharyngeal Diseases Compared With Drug Septolete Total, Lozenges

Inclusion Criteria27

• Male or female patients aged 18 to 75 years inclusive.
• Symptom "sore throat" due to infectious-inflammatory diseases of the pharynx (acute pharyngitis, acute nasopharyngitis, exacerbation of chronic pharyngitis) based on one or more of the following clinical manifestations:
• Unpleasant sensations/discomfort in the throat - symptoms of pharyngeal paresthesia (scratchy throat, dryness or sore sensation ("foreign body" sensation));
• Painful sensations in the throat, including sore throat at rest, throat burning, or pain upon swallowing saliva;
• Severity of the symptom "sore throat" from 55 mm to 80 mm on the Visual Analog Scale (VAS).
• A score of 5 to 8 points on the Clinical Symptom Severity Scale for tonsillopharyngitis.
• Absence of indications for systemic antibacterial therapy at the time of inclusion in the study.
• Negative test result for β-hemolytic streptococcus.
• Duration of disease symptoms not exceeding 3 days at the time of inclusion in the study.
• Women with a negative pregnancy test who have used one or more of the following contraceptive methods for 8 weeks prior to and during the 3 weeks after the end of the study: intrauterine devices (IUDs), oral contraceptives, contraceptive patches, long-acting injectable contraceptives, double barrier contraceptive method; or women who are infertile (documented conditions: hysterectomy, tubal ligation, infertility, menopause for more than 1 year); or men using a double barrier contraceptive method (condom with spermicide) throughout the study and for 3 weeks after its conclusion or men who are infertile (documented conditions: vasectomy, infertility).
• Signed and dated informed consent form.
• Trauma and/or burns of the oropharynx, scarlet fever, rubella, measles at the time of inclusion in the study and not earlier than 3 months before inclusion in the study.
• Treatment with any systemic antibacterial agents within 14 days prior to inclusion in the study.
• Use of non-steroidal anti-inflammatory drugs and/or decongestants within 12 hours prior to the randomization visit.
• Body temperature at screening and randomization visits ≥ 38.5 °C.
• Infectious-inflammatory diseases requiring combined or systemic antibacterial therapy.
• Severe, decompensated, or unstable somatic diseases (any diseases or conditions that threaten the patient's life or worsen the prognosis of the underlying disease, as well as make it impossible for the patient to participate in the clinical study).
• History of malignancy, exept for subjects who have been disease-free for at least 5 years prior to screening.
• Allergic history.
• Participation in any other clinical study within 90 days prior to inclusion in the study.
• Pregnancy or breastfeeding in women.
• Refusal to use effective contraceptive methods during the study.
• Alcoholism, drug addiction, abuse of psychotropic medications, including in history.
• Smoking more than 10 cigarettes per day.
• Positive urine test for narcotic substances and potent medications.
• Vaccination within 21 days prior to study enrollment.
• Other conditions that, in the opinion of the investigator, prevent the patient from being included in the study.