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Comparing the effectiveness and side effects of two injections in the treatment of giddiness and hearing loss

A Randomised Control Trial comparing the effectiveness of Intratympanic Gentamicin with Intratympanic Methylprednisolone in the treatment of patients with intractable unilateral Meniereâ??s disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/08/009370
Enrollment
56
Registered
2017-08-14
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- Unilateral Intractable Menieres Disease

Interventions

Intervention1: Intratympanic Injection Gentamycin: Inj. Gentamycin 40mg/ml 4 injections given every alternate day over a total duration of 1 week Control Intervention1: Intratympanic Injection Methylp

Sponsors

Christian Medical College Vellore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Definite menieres disease(ICVD 2015) 2. refractory to medical treatment for atleast 6 months 3.average PTA of 50dB in the affected ear 4. no retrocochlear/CNS disease

Exclusion criteria

Exclusion criteria: - presence of other otological diagnosis - allergy to gentamycin - history of intratympanic injections

Design outcomes

Primary

MeasureTime frame
Assessment of the improvement in Vertigo, Tinnitus and Functional scalesTimepoint: 3 month post intervention 1 year post intervention—

Secondary

MeasureTime frame
1. assessment of change in hearing post intervention 2. assessment of safety and side effects of either injectionTimepoint: 3 months post intervention 1 year post intervention—

Countries

India

Contacts

Public ContactDr Leah Thomas Waran

Christian Medical College Vellore

anjalilepcha@gmail.com9677413151

Outcome results

None listed

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