Back to resultsEffectiveness of Intratympanic Dexamethasone With Ligmocaine for Alleviation of Tinnitus
Primary Purpose
Tinnitus
Status
Unknown status
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus
Eligibility Criteria
Inclusion Criteria:
- score 20 or above on modified tinnitus handicap inventory
Exclusion Criteria:
- head trauma, tympanic membrane perforation, depression, ear surgery
Sites / Locations
- Combined Military Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dexamethasone with lignocaine
Arm Description
Outcomes
Primary Outcome Measures
Tinnitus relief
Tinnitus relief ascertained by Modified Tinnitus Handicap Inventory
Secondary Outcome Measures
Full Information
NCT ID
NCT04798391
First Posted
March 6, 2021
Last Updated
March 12, 2021
Sponsor
Combined Military Hospital, Pakistan
1. Study Identification
Unique Protocol Identification Number
NCT04798391
Brief Title
Effectiveness of Intratympanic Dexamethasone With Ligmocaine for Alleviation of Tinnitus
Official Title
Effectiveness of Dexamethasone With Lignocaine for Alleviation of Tinnitus
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Combined Military Hospital, Pakistan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Objective: To determine the effectiveness of Intratympanic dexamethasone with lignocaine in control of idiopathic tinnitus.
Methodology: 264 consenting patients with idiopathic unilateral tinnitus presenting at ENT Department were assessed for tinnitus severity using Modified Tinnitus Handicap Inventory and the scores recorded and subsequently administered intratympanically 2.0 ml (milliliter's) of dexamethasone and lignocaine (1.5 ml dexamethasone + 0.5 ml 1% lignocaine). The dose was repeated twice at weekly intervals. All patients were re assessed on Modified Tinnitus Handicap Inventory two weeks after third Intratympanic administration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
264 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone with lignocaine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Lignocaine
Intervention Description
Steroids and analgesics
Primary Outcome Measure Information:
Title
Tinnitus relief
Description
Tinnitus relief ascertained by Modified Tinnitus Handicap Inventory
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
score 20 or above on modified tinnitus handicap inventory
Exclusion Criteria:
head trauma, tympanic membrane perforation, depression, ear surgery
Facility Information:
Facility Name
Combined Military Hospital
City
Quetta
State/Province
Balochistan
ZIP/Postal Code
1234
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Intratympanic Dexamethasone With Ligmocaine for Alleviation of Tinnitus
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