Health Condition 1: H661- Chronic tubotympanic suppurative otitis media
Conditions
Interventions
None listed
Sponsors
Dr Atul Kumar Ahirwar
Eligibility
Inclusion criteria
Inclusion criteria: At least one ear must meet all of the following criteria: a) Patients 5 to 50 years of age, diagnosed with CSOM (having purulent or mucopurulent ear discharge for at least 2 weeks with tympanic membrane perforation). b) Patientâ??s culture sensitivity test shows flora sensitive to ofloxacin (for control group). c) Patients able and willing to provide written informed consent. d) No expectation that subject will be moving out of the area of the study center during the next 2 months.
Exclusion criteria
Exclusion criteria: a) Patients with a history of hypersensitivity to any of the trial or control drugs. b) Patients having tuberculosis, diabetes mellitus, immunosuppressive disease, fungal or viral disease, any clinically significant systemic diseases. c) Patients with chronic nasal obstruction, persistent rhinorrhoea, cholesteatoma and active atticoantral disease. d) Pregnant and lactating women. e) Patients with ear surgery in the preceding 12 months or an insitu grommet or tympanostomy tube, congenital ear or hearing problems, middle ear obstruction (e.g., polyp). f) Patients who had taken systemic steroids, high dose of topical steroids and/or antibiotics in the previous one week and had temperature >38 degree Celsius. g) Patientâ??s culture sensitivity test shows flora resistant to ofloxacin (for control group). h)Patients who will unable to continue for the proposed length of treatment or return for follow-up visits. i) Active participation in any type of intervention study. j) Patients who start developing complications. A patient may have both ears eligible at the time of randomization. In that case worse ear will be selected for treatment analysis and documentation purpose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eradication of infection assessed by microbial C & S of ear discharge (mean change in ear discharge) between baseline and day 15.Timepoint: day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Mean change in size of tympanic membrane perforation assessed by Ear Endoscopy between baseline and 2 month. 2.Mean change in hearing assessed by Pure Tone Audiometry between baseline and 2 month. Timepoint: day 60 | — |
Countries
India
Contacts
Public ContactDr Atul Kumar Ahirwar
Government Ayurvedic College, Kadamkuan, Patna-3, Bihar, India
Outcome results
None listed