Clinical Study for Comparative Assessment of Efficacy and Safety of Angal S, Topical Spray and ANTI-ANGIN® FORMULA, Topical Metered Spray in Treatment of Patients With Uncomplicated Acute Infectious and Inflammatory Diseases of the Pharynx, Accompanied by a Sore Throat
Condition: Sore Throat
MeSH terms: Pharyngitis; Pharyngeal Diseases
Intervention: Angal S, topical spray [Menthol]; ANTI-ANGIN® FORMULA, topical metered spray
Intervention description: 0,5 mg + 2 mg (Sandoz d.d., Slovenia), administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution; 0,12 mg + 0,24 mg (LLC "Valeant", Russia) administered as one to two consecutive presses on the actuator button, up to 6 times per day, , for a maximum 5 days or until full illness resolution
Intervention MeSH terms: Menthol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 229.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Angal S; ANTI-ANGIN FORMULA; Sore Throat; no less therapeutic efficacy

Summary:

      The purpose of this study was to evaluate no less therapeutic efficacy and safety of the
      Angal S, topical spray [Menthol], 0,5 mg + 2 mg (Sandoz dd, Slovenia) compared to ANTI-ANGIN®
      FORMULA, topical metered spray, 0,12 mg + 0,24 mg (LLC "Valeant", Russia) in treatment of
      patients with uncomplicated acute infectious and inflammatory diseases of the pharynx,
      accompanied by a sore throat.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Voluntarily signed informed consent for participation in this clinical study;

          -  18 to 45 years old inclusive, male and female;

          -  Diagnosed uncomplicated acute infectious and inflammatory diseases of the pharynx,
             accompanied by a sore throat;

          -  Onset of first symptoms of the uncomplicated acute infectious and inflammatory
             diseases of the pharynx (pharyngitis and/or tonsillitis) less than 48 hours prior to
             inclusion into the study; Baseline TSS score (Tonsillopharyngitis Severity Score) ≥ 5
             (total score);

          -  Body temperature 37,5 C (axillary).

        Exclusion Criteria:

          -  Use of analgesics within <12 hours prior to the study start or/and inability to cancel
             them during the study;

          -  Use of antibiotics within <48 hours prior to the study start or/and inability to
             cancel them during the study;

          -  Use of local therapy (sprays, rinses, lozenges) to pharynx within <12 hours before
             study start or/and inability to cancel them, besides study medications;

          -  Use systemic or inhaled corticosteroids within ≤1 months prior to the study start and
             planned therapy of them during the study (besides skin means);

          -  Presence of symptoms of primary bacterial pharyngitis or secondary bacterial infection
             (including fever over 37,5 ° C, the presence of purulent raids in the throat, severe
             intoxication, leukocytosis, neutrophilia, shift leukocyte left (increasing the
             percentage of neutrophils sticks appearance younger forms of neutrophils), increased
             ESR 30 mm/hr).