Skip to content

It is a study that compare two drugs named Ofloxacin and its Combination with Dexamethasone in the patients of long term ear discharge.

Efficacy and Safety of Ofloxacin and its Combination with Dexamethasone in Chronic Suppurative Otitis Media - A Randomized, Double Blind, Parallel Group, Comparative Study.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/07/002784
Enrollment
120
Registered
2012-07-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Chronic suppurative otitis media Health Condition 2: H663- Other chronic suppurative otitis media

Interventions

Intervention1: Ofloxacin ear drops: Ofloxacin ear drops is going to administer 5 drops 2 times a day for 10 days or until absence of ear discharge Control Intervention1: Ofloxacin and Dexamethasone co

Sponsors

Government Medical College Bhavnagar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age above 12 years to 70 years of either sex Patient with at least 2 weeks of otorrhoea and Tympenic membrane perforation without cholesteatoma Ability to give written inform consent Patient with ear discharge organism which is sensitive to ofloxacin

Exclusion criteria

Exclusion criteria: Patients with a history of sensitivity to any of the trial drugs Pregnant or lactating women Patients with tuberculosis diabetes acute renal disease immunosuppressive Disease fungal or viral diseases Patient with chronic nasal obstruction Persistant rhinorrhoea and Cholesteatoma Patients with unsafe ears active atticoantral disease Patients who were unable to continue for the proposed length of treatment or return for follow-up visits Current antibiotic use or use in the preceding 1 week Patients who do not give informed consent Patient with recent ear surgery or an insitu grommet or tympanostomy tube mastoid surgery in the preceding 12 months congenital ear or hearing problems obstructed middle ear (eg polyp) Patient is on oral steroid or high dose of topical steroid Patient is on oral steroid or high dose of topical steroid Patient is having temperature >38c

Design outcomes

Primary

MeasureTime frame
Clinical cure on reviewTimepoint: Clinical cure on review on 5th 10th 15th days

Secondary

MeasureTime frame
size of the perforation or complete healing Pure tone audiometry Timepoint: at 5 days at 10 days 15 days

Countries

India

Contacts

Public ContactDr Ashwin K Panchasara

Government Medical College Bhavnagar

cbrtripathi@yahoo.co.in09825951678

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026