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Comparison of oral medication and surgery to treat tuberculosis of middle ear.

Comparison of anti- tuberculous medication and surgery in patients with tuberculous otitis media â?? a Randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/024147
Enrollment
26
Registered
2020-03-20
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: H679- Otitis media in diseases classified elsewhere, unspecified ear

Interventions

Intervention1: Tympanomastoid exploration: Removal of middle ear granulations and infection Control Intervention1: Anti tubercular treatment: Oral drugs 6 months anti tubercular HRZ regimen

Sponsors

Karpaga Vinayaka Institute of Medical sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with complaints suggestive of TB otitis media Age >18 years Patient willing to undergo surgery and take ATT Patient willing to give consent

Exclusion criteria

Exclusion criteria: H/O previous ear surgery H/O previous ATT H/O other ear pathology H/O sensorineural hearing loss

Design outcomes

Primary

MeasureTime frame
audiogram, Ear swab, Acid fast bacilli staining, histology, Mycobacterium tuberculosis culture, Polymerised chain reaction and CT findingsTimepoint: 0, 3, 6 ,months—

Secondary

MeasureTime frame
audiogram, Ear swab, Acid fast bacilli staining, histology, Mycobacterium tuberculosis culture, Polymerised chain reaction and CT findingsTimepoint: 12 months—

Countries

India

Contacts

Public ContactDr S Mohana Karthikeyan

Karpaga Vinayaka Institute of Medical sciences

karthient@gmail.com

Outcome results

None listed

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