Vestibular Rehabilitation With Intratympanic Drug Therapy in Meniere's Disease

April 27, 2022 updated by: Dr Zeeshan Ayub, Combined Military Hospital Quetta

Objective Vestibular Evaluation & Rehabilitation With Intratympanic Dexamethasone and Gentamicin in Meniere's Disease

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 Type

Interventional

Enrollment (Anticipated)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Balochistan
      • Quetta, Balochistan, Pakistan, 87300
        • Recruiting
        • Cmh Quetta
        • Contact:
          • Zeeshan Ayub, FCPS
          • Phone Number: +923215233648
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

24 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Bilateral disease, operated cases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vestibular severity index improvement
Improvement in vestibular symptoms with intratympanic gentamicin
Drug: Gentamicin
Intratympanic gentamicin and dexamethasone administered in two doses one week apart
Other Names:
  • Intratympanic gentamicin
Drug: Dexamethasone
Intratympanic gentamicin and dexamethasone administered in two doses one week apart
Other Names:
  • Intratympanic dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vestibular Rehabilitation
Time Frame: Three months
Improvement in vestibular severity index
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Combined Military Hospital Quetta

Investigators

  • Principal Investigator: Zeeshan Ayub, FCPS, Cmh Quetta
  • Study Chair: Zeeshan Ayub, FCPS, Cmh Quetta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

April 22, 2022

Study Completion (Anticipated)

May 30, 2022

Study Registration Dates

First Submitted

April 24, 2022

First Submitted That Met QC Criteria

April 27, 2022

First Posted (Actual)

May 2, 2022

Study Record Updates

Last Update Posted (Actual)

May 2, 2022

Last Update Submitted That Met QC Criteria

April 27, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • File No: CMH QTA-IRB/043

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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