NCT04798391

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

March 15, 2021

Status Verified

March 1, 2021

Enrollment Period

1 month

First QC Date

March 6, 2021

Last Update Submit

March 12, 2021

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

  • Tinnitus relief

    Tinnitus relief ascertained by Modified Tinnitus Handicap Inventory

    2 weeks

Study Arms (1)

Dexamethasone with lignocaine

EXPERIMENTAL
Drug: Dexamethasone

Interventions

DexamethasoneDRUG

Steroids and analgesics

Also known as: Lignocaine
Dexamethasone with lignocaine

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • score 20 or above on modified tinnitus handicap inventory

You may not qualify if:

  • head trauma, tympanic membrane perforation, depression, ear surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Combined Military Hospital

Quetta, Balochistan, 1234, Pakistan

Location

MeSH Terms

Conditions

Tinnitus

Interventions

DexamethasoneLidocaine

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CLASSIFIED SPECIALIST

Study Record Dates

First Submitted

March 6, 2021

First Posted

March 15, 2021

Study Start

March 1, 2021

Primary Completion

April 1, 2021

Study Completion

May 1, 2021

Last Updated

March 15, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)