LiveSpo Navax® Supports the Treatment of Acute Rhinosinusitis and Otitis Media
- Conditions
- Upper Respiratory Tract Infections
- Registration Number
- NCT05804123
- Lead Sponsor
- Anabio R&D
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 175
Inclusion Criteria:<br><br> - Patients diagnosed with acute rhinosinusitis: sudden onset of two or more symptoms,<br> one of which should be either nasal blockage/obstruction/congestion or nasal<br> discharge (anterior/posterior nasal drip); and/or facial pain/pressure; and/or<br> reduction or loss of smell for <12 weeks. In children: sudden onset of two or more<br> of the symptoms: nasal blockage/obstruction/congestion or discolored nasal<br> discharge, or cough (daytime and night-time) for < 12 weeks<br><br> - Patients diagnosed with acute rhinosinusitis accompanied by acute otitis media:<br> patients from 6 months to 7 years old, suffer from onset ear discharge not caused by<br> otitis external, the tympanic membrane was ruptured with purulent.<br><br> - Patients are hospitalized or treated as outpatients but need periodic re-examination<br><br> - Have a complete medical record or medical examination book<br><br> - For patients under 18 years old, the patient's parents agreed to participate in the<br> study that was explained and signed the study consent form.<br><br> - Patients >18 years old: patients agreed to participate in the study, explained, and<br> signed the study consent form.<br><br>Exclusion Criteria:<br><br> - The patient did not agree to participate in the study.<br><br> - There are not enough medical records or medical examination books.<br><br> - The patient moves out of the treatment unit (not for professional reasons).<br><br> - The outpatients but no periodic re-examination.<br><br> - Patients with congenital deafness, or deafness due to neurological causes:<br> meningitis, obstetric complications, ear poisoning...<br><br> - Patients with congenital disease-causing disorders of maxillofacial development and<br> mental and physical retardation.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in percentages of patients with free acute rhinosinusitis symptoms;Changes in percentages of patients with free acute otitis media symptoms
- Secondary Outcome Measures
Name Time Method Changes in infection bacterial concentrations can cause acute rhinosinusitis (ARS) and acute otitis media (AOM);Changes in cytokines level;Changes in immunoglobulin A level