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:
Drug: Dexamethasone
Intratympanic gentamicin and dexamethasone administered in two doses one week apart
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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: