Comparison of efficacy and safety of Amoxicillin-clavulanic acid versus ciprofloxacin in patient of active stage of tubotympanic type of chronic suppurative otitis media in a tertiary care hospital - a prospective, randomized, Open-label study - nil

Indira Gandhi Government medical college and Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月1日

试验速览

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•Participants to be attending the outpatient clinic in the department of ENT,
•1. Adults of either sex, greater than 18 years
•2. Clinically documented or New cases of a tubo-tympanic variety of CSOM with clinical signs
•& symptoms of the disease and baseline otological symptom score of >4 but = 8 were
•included in the study12
•3. Patients willing to participate in the study by giving Informed consent
•4. Outpatient department

•1. Atticoantral type of chronic suppurative otitis media
•2. Age less than 18 years
•3. Impending complications
•4. Patients with acute otitis media and all physical and other subtypes of otitis media, such
•as otitis media with effusion.
•5. Otomycosis
•6. Severe cases of CSOM for which hospitalization or parenteral antibiotic treatment is
•required and patients with otological symptom score of =4 and >8 were also excluded
•from the study
•7. Patients with foul-smelling Ear discharge
•8. Large aural polyp in the middle ear
•9. Patients who, received antibiotics either topical or systemic in the preceding 4 weeks of
•10.Otological surgery within the past year
•11. Presence of tympanostomy tube
•12. Acute traumatic perforation
•13. Symptomatic conditions such as otitis externa, chronic sinusitis, chronic pharyngitis
•requiring systemic antibiotic therapy that could interfere with the evaluation of study
•14. History of allergies to the study medication
•15. Acute serious illness (like Myocardial Infarction, Stroke, Sepsis, Electrolyte disturbances)
•16. Known case of any malignancy
•17. Known case of any liver and kidney disease
•18.Pregnant women and lactating mothers
•19. Patients in Inpatient department
•20. Underlying chronic diseases such as Diabetes mellitus, Tuberculosis
•21. Known case of immunodeficiency.

发起方

Indira Gandhi Government medical college and Hospital