A Local Clinical Study for the Comparative Evaluation of Efficacy and Safety of Angal, Lozenges [Menthol] and ANTI-ANGIN® FORMULA, Lozenges, in Treatment of Patients With a Sore Throat
Condition: Sore Throat
MeSH terms: Pharyngitis
Intervention: Angal, lozenges [menthol],; ANTI-ANGIN® FORMULA
Intervention description: Angal, administered per 1 lozenge, with an interval 2 hours or more, 6-10 lozenges per day, for a maximum 4 days or until full illness resolution.; 0,2 mg + 2 mg + 50 mg (LLC "Valeant", Russia). Administered per 1 lozenge, with an interval 2 hours or more, up to 6 lozenges 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: 228.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Angal; 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, lozenges [Menthol], 1 mg + 5 mg (Sandoz dd, Slovenia) compared to ANTI-ANGIN® FORMULA,
      lozenges, 0,2 mg + 2 mg + 50 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);

        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);