Efficacy and Safety of Magnólia Nasal Gel in the Treatment of Allergic Rhinitis

Inclusion Criteria:

• Ability to confirm voluntary participation and agree to all trial purposes by signingand dating the informed consent forms;
• Participants of both sexes, with age greater than or equal to 12 years;
• Clinical diagnosis of moderate-severe persistent or moderate-severe intermittentallergic rhinitis, according to the ARIA classification;
• Present the general status of rhinitis as moderate or severe;
• Total nasal symptom score greater than or equal to 6 points, with congestion and oneor more of the other symptoms present (itching, runny nose, and sneezing) with a scoregreater than or equal to 2 at the screening visit;
• Present skin sensitization test to at least one aeroallergen;

Exclusion Criteria:

• Any clinical and laboratory findings that, in the judgment of the investigator, mayinterfere with the safety of research participants;
• History of alcohol abuse or illicit drug use;
• Participation in a clinical trial in the year before this study;
• Pregnancy or risk of pregnancy and lactating patients;
• Known hypersensitivity to the formula components used during the clinical trial;
• Participants who present other clinical forms of rhinitis, such as, but not restrictedto medicated rhinitis, vasomotor and atrophic;
• Participants dependent on decongestants (nasal or oral) or receiving allergen-specificimmunotherapy;
• Participants with suggestive signs of upper airways bacterial infection;
• Participants with grade II or III septum deviation and/or presence of nasal polyps orother conditions that lead to nasal obstruction;
• Concomitant chronic or intermittent use of decongestants, antihistamines, orcorticosteroids by inhalation, oral, intramuscular, or intravenous;
• Concomitant use of potent topical corticosteroids.