Vestibular Rehabilitation With Intratympanic Drug Therapy in Meniere's Disease

NCT ID: NCT05355610

Last Updated: 2022-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-05-30

Brief Summary

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Intractable symptoms of Meniere's disease will be treated with intratympanic steroids.

At the same time intratympanic dexamethasone will be used to rescue hearing

Detailed Description

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For Alleviation of Intractable symptoms of Meniere's disease will be treated with intratympanic steroids. Measured with pre and post therapy vestibular severity index.

At the same time intratympanic dexamethasone will be used to rescue hearing measured with speech reception threshold and speech discrimination threshold

Conditions

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Vestibular Disorder Preservation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients with unilateral Meniere's disease with intractable vertigo will be administered two doses of intratympanic gentamicin plus dexamethasone 1 week apart
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

For Alleviation of Intractable symptoms of Meniere's disease will be treated with intratympanic steroids. Measured with pre and post therapy vestibular severity index.

At the same time intratympanic dexamethasone will be used to rescue hearing measured with speech reception threshold and speech discrimination threshold

Study Groups

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Vestibular severity index improvement

Improvement in vestibular symptoms with intratympanic gentamicin

Group Type EXPERIMENTAL

Gentamicin

Intervention Type DRUG

Intratympanic gentamicin and dexamethasone administered in two doses one week apart

Dexamethasone

Intervention Type DRUG

Intratympanic gentamicin and dexamethasone administered in two doses one week apart

Interventions

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Gentamicin

Intratympanic gentamicin and dexamethasone administered in two doses one week apart

Intervention Type DRUG

Dexamethasone

Intratympanic gentamicin and dexamethasone administered in two doses one week apart

Intervention Type DRUG

Other Intervention Names

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Intratympanic gentamicin Intratympanic dexamethasone

Eligibility Criteria

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Inclusion Criteria

* All patients of unilateral Meniere's disease with severe vestibular symptoms

Exclusion Criteria

* Bilateral disease, operated cases
Minimum Eligible Age

24 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Combined Military Hospital Quetta

OTHER

Sponsor Role lead

Responsible Party

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Dr Zeeshan Ayub

Associate Professor ENT

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zeeshan Ayub, FCPS

Role: PRINCIPAL_INVESTIGATOR

CMH Quetta

Zeeshan Ayub, FCPS

Role: STUDY_CHAIR

CMH Quetta

Locations

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CMH Quetta

Quetta, Balochistan, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Zeeshan Ayub, FCPS

Role: CONTACT

+923215233648

Zeeshan Ayub, FCPS

Role: CONTACT

03215233648

Facility Contacts

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Zeeshan Ayub, FCPS

Role: primary

+923215233648

Azeema Ahmed, FCPS

Role: backup

+923325222335

Other Identifiers

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File No: CMH QTA-IRB/043

Identifier Type: -

Identifier Source: org_study_id

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