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NCT04798391 Clinical Trial

Effectiveness of Intratympanic Dexamethasone With Ligmocaine for Alleviation of Tinnitus

Tinnitus Clinical Trial

Official title:
Effectiveness of Dexamethasone With Lignocaine for Alleviation of Tinnitus

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04798391
Other study ID # CMHQ
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date March 1, 2021
Est. completion date May 2021

Study information
Verified date March 2021
Source Combined Military Hospital, Pakistan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 264
Est. completion date May 2021
Est. primary completion date April 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years to 75 Years
Eligibility Inclusion Criteria: - score 20 or above on modified tinnitus handicap inventory Exclusion Criteria: - head trauma, tympanic membrane perforation, depression, ear surgery

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dexamethasone
Steroids and analgesics

Locations
Country Name City State
Pakistan Combined Military Hospital Quetta Balochistan

Sponsors (1)
Lead Sponsor Collaborator
Combined Military Hospital, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tinnitus relief Tinnitus relief ascertained by Modified Tinnitus Handicap Inventory 2 weeks
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