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Gentamicin intratympanic injection concurrent with dexamethasone in refractory Meniere’s disease.

Gentamicin intratympanic injection concurrent with dexamethasone in refractory Meniere’s disease.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008375
Enrollment
50
Registered
2023-04-21
Start date
2023-06-02
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

None listed

Interventions

Drug : Group1 -Gentamicin sulfate (80mg/2ml) 0.6ml + Normal Saline 0.4ml 1ml (concentration of gentamicin : 24mg/ml) intratympanic injection . Group2 - Gentamicin sulfate (80mg/2ml) 0.6ml + Dexame

Sponsors

Yonsei University Health System, Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Definite Meniere’s disease -If there is no improvement in medication treatment for more than 3 months and there is more than 1 dizziness attack per month -The average hearing on the affected side is more than mild hearing loss (0.5, 1, 2, 3 kHz average airway hearing threshold > 25 dB on pure tone audiometry)

Exclusion criteria

Exclusion criteria: -When CNS-caused dizziness is suspected -Symptoms after head trauma -Past history of other otological diseases such as otitis media -Bilateral Meniere's disease -Taking steroids for an underlying disease -If the affected side is the better ear (when the average airway hearing threshold of the affected side is lower than the contralateral side on pure tone audiometry)

Design outcomes

Primary

MeasureTime frame
Hearing difference between the two groups after treatment

Secondary

MeasureTime frame
Proportion of patients who dropped out due to the need for additional treatment after treatment in both groups;Serial hearing change after treatment in both groups;Changes in vestibular function (caloric, vHIT) after treatment in both groups;Frequency of dizziness after treatment in both groups

Countries

Korea, Republic of

Contacts

Public ContactSeong Hoon Bae

Yonsei University Health System, Severance Hospital

bshsap@naver.com+82-2-2228-3600

Outcome results

None listed

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