Vestibular Rehabilitation With Intratympanic Drug Therapy in Meniere's Disease
Primary Purpose
Vestibular Disorder Preservation
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Gentamicin
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Vestibular Disorder Preservation focused on measuring dexamethasone, gentamicin
Eligibility Criteria
Inclusion Criteria:
- All patients of unilateral Meniere's disease with severe vestibular symptoms
Exclusion Criteria:
- Bilateral disease, operated cases
Sites / Locations
- CMH QuettaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vestibular severity index improvement
Arm Description
Improvement in vestibular symptoms with intratympanic gentamicin
Outcomes
Primary Outcome Measures
Vestibular Rehabilitation
Improvement in vestibular severity index
Secondary Outcome Measures
Full Information
NCT ID
NCT05355610
First Posted
April 24, 2022
Last Updated
April 27, 2022
Sponsor
Combined Military Hospital Quetta
1. Study Identification
Unique Protocol Identification Number
NCT05355610
Brief Title
Vestibular Rehabilitation With Intratympanic Drug Therapy in Meniere's Disease
Official Title
Objective Vestibular Evaluation & Rehabilitation With Intratympanic Dexamethasone and Gentamicin in Meniere's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 22, 2022 (Actual)
Study Completion Date
May 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Combined Military Hospital Quetta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Disorder Preservation
Keywords
dexamethasone, gentamicin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients 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
Allocation
N/A
Enrollment
93 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vestibular severity index improvement
Arm Type
Experimental
Arm Description
Improvement in vestibular symptoms with intratympanic gentamicin
Intervention Type
Drug
Intervention Name(s)
Gentamicin
Other Intervention Name(s)
Intratympanic gentamicin
Intervention Description
Intratympanic gentamicin and dexamethasone administered in two doses one week apart
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Intratympanic dexamethasone
Intervention Description
Intratympanic gentamicin and dexamethasone administered in two doses one week apart
Primary Outcome Measure Information:
Title
Vestibular Rehabilitation
Description
Improvement in vestibular severity index
Time Frame
Three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients of unilateral Meniere's disease with severe vestibular symptoms
Exclusion Criteria:
Bilateral disease, operated cases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zeeshan Ayub, FCPS
Phone
+923215233648
Email
zeeshanent@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zeeshan Ayub, FCPS
Phone
03215233648
Email
zeeshanent@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeeshan Ayub, FCPS
Organizational Affiliation
CMH Quetta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zeeshan Ayub, FCPS
Organizational Affiliation
CMH Quetta
Official's Role
Study Chair
Facility Information:
Facility Name
CMH Quetta
City
Quetta
State/Province
Balochistan
ZIP/Postal Code
87300
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zeeshan Ayub, FCPS
Phone
+923215233648
First Name & Middle Initial & Last Name & Degree
Azeema Ahmed, FCPS
Phone
+923325222335
Email
azeemazeeshan1980@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Vestibular Rehabilitation With Intratympanic Drug Therapy in Meniere's Disease
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