A clinical trial about Comparing effectiveness and side effects of Amoxicillin-clavulanic acid versus ciprofloxacin in patient of chronic suppurative otitis media in ahospital
- Conditions
- Health Condition 1: H661- Chronic tubotympanic suppurative otitis media
- Registration Number
- CTRI/2024/03/064148
- Lead Sponsor
- Indira Gandhi Government medical college and Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
screening
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
drugs
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients showing complete stoppage of otorrhea at the end of 2 weeksTimepoint: reduction of otorrhea after 3 days, 1 week and 2 weeks
- Secondary Outcome Measures
Name Time Method Analyzing the cost-effective analysis of antimicrobialsTimepoint: cost effective analysis will be done at day 0 , day 3 , day7 and day 14;Ear discharge must be sterile or no pus after completion of course of treatment <br/ ><br>Timepoint: ear discharge will be swabbed at day 0 and day 14;Recording of adverse event, if any, according to the prescribed proforma issued by <br/ ><br>Pharmacovigilance program of India (PvPI).Timepoint: adverse drug reactions are noted at any point of time after drug intake