Health Condition 1: H661- Chronic tubotympanic suppurative otitis media Health Condition 2: null- Mild to moderate cases of acute exacerbation of chronic suppurative otitis media
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adults of either sex 2.Aged between 18 and 60 3.Clinically documented cases of tubo-tympanic type chronic suppurative otitis media defined as long standing chronic suppuration of middle ear cleft and its muco-periosteal lining resulting in discharging ear and deafness presenting with clinical symptoms and signs of acute exacerbation of the disease 4.Baseline otological symptom score of more than 4 but less than 8
Exclusion criteria
Exclusion criteria: 1.Female patients who are pregnant or lactating 2.Severe cases of AECSOM for which hospitalization or parenteral antibiotic treatment is required and 3. Patients with otological symptom score of less than4 and more than 8 will be also excluded from the study. 4.Patients with foul smelling discharge and those who received antibiotic in preceding 4 weeks of screening will be left out.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cure Subject will be categorized as "clinical cure" if otological symptom score is less than 3 at the day 14 visit.Timepoint: day 14 visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical improvement Subject will be categorized as "clinical improvement" if there is at least one scale one scale reduction from baseline score between 3 to 5 at the day 14 visit assessment.Timepoint: day 14 visit | — |
Countries
India
Contacts
Nilratan Sircar Medical College