Vestibular Rehabilitation With Intratympanic Drug Therapy... | NCT05355610

Studies
Vestibular Rehabilitation With Intratympanic Drug Therapy in Meniere's Disease

NCT05355610

Sponsor

Combined Military Hospital Quetta

Status

Unknown status

Last Update Posted

May 2, 2022Actual

Enrollment

93Estimated

Phase

Not Applicable

Conditions

Vestibular Disorder Preservation

Interventions

Gentamicin
Dexamethasone

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2021Actual

Primary Completion Date

Apr 22, 2022Actual

Completion Date

May 30, 2022Estimated

First Submitted Date

Apr 24, 2022

First Submission Date that Met QC Criteria

Apr 27, 2022

First Posted Date

May 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2022

Last Update Posted Date

May 2, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Zeeshan Ayub, Associate Professor ENT, Combined Military Hospital QuettaPrincipal Investigator

Lead Sponsor

Combined Military Hospital QuettaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

93Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vestibular severity index improvement	Experimental	Improvement in vestibular symptoms with intratympanic gentamicin	Drug: Gentamicin Drug: Dexamethasone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gentamicin	Drug	Intratympanic gentamicin and dexamethasone administered in two doses one week apart	Vestibular severity index improvement

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Bilateral disease, operated cases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

24 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zeeshan Ayub, FCPS	Contact	+923215233648		zeeshanent@yahoo.com
Zeeshan Ayub, FCPS	Contact	03215233648		zeeshanent@yahoo.com

Overall Officials

Name	Affiliation	Role
Zeeshan Ayub, FCPS	CMH Quetta	Principal Investigator
Zeeshan Ayub, FCPS	CMH Quetta	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CMH Quetta	Recruiting	Quetta	Balochistan	87300	Pakistan

Intervention Browse Module

MeSH Terms

ID	Term
D005839	Gentamicins
D003907	Dexamethasone

Ancestor Terms

ID	Term
D000617	Aminoglycosides
D006027	Glycosides
D002241	Carbohydrates
D011246	Pregnadienetriols

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

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

Who Masked

Not provided