Vestibular Rehabilitation With Intratympanic Drug Therapy in Meniere's Disease

Sponsor
Combined Military Hospital Quetta (Other)
Overall Status
Recruiting
CT.gov ID
NCT05355610
Collaborator
(none)
93
1
1
13.9
6.7

Study Details

Study Description

Brief Summary

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

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

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
93 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Patients with unilateral Meniere's disease with intractable vertigo will be administered two doses of intratympanic gentamicin plus dexamethasone 1 week apartPatients with unilateral Meniere's disease with intractable vertigo will be administered two doses of intratympanic gentamicin plus dexamethasone 1 week apart
Masking:
None (Open Label)
Masking 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
Primary Purpose:
Treatment
Official Title:
Objective Vestibular Evaluation & Rehabilitation With Intratympanic Dexamethasone and Gentamicin in Meniere's Disease
Actual Study Start Date :
Apr 1, 2021
Actual Primary Completion Date :
Apr 22, 2022
Anticipated Study Completion Date :
May 30, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Vestibular Rehabilitation [Three months]

      Improvement in vestibular severity index

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    24 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients of unilateral Meniere's disease with severe vestibular symptoms
    Exclusion Criteria:
    • Bilateral disease, operated cases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CMH Quetta Quetta Balochistan Pakistan 87300

    Sponsors and Collaborators

    • Combined Military Hospital Quetta

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Zeeshan Ayub, Associate Professor ENT, Combined Military Hospital Quetta
    ClinicalTrials.gov Identifier:
    NCT05355610
    Other Study ID Numbers:
    • File No: CMH QTA-IRB/043
    First Posted:
    May 2, 2022
    Last Update Posted:
    May 2, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr Zeeshan Ayub, Associate Professor ENT, Combined Military Hospital Quetta
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 2, 2022