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Status unknownNCT04798391Updated Mar 15, 2021

Effectiveness of Intratympanic Dexamethasone With Ligmocaine for Alleviation of Tinnitus

A Phase 4 interventional study of Dexamethasone in Tinnitus, sponsored by Combined Military Hospital, Pakistan. Status unknown at 1 site in Pakistan. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-03-15.

Sponsored by Combined Military Hospital, Pakistan · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
264
Allocation
Not applicable
Ages
19 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Tinnitus

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03

In context

Tinnitus

444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.

This study's planned enrollment of 264 is above the median of 60 across 368 interventional studies indexed under Tinnitus.

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Lead sponsor

Combined Military Hospital, Pakistan is the lead sponsor of 15 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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Inclusion criteria

  • score 20 or above on modified tinnitus handicap inventory

Exclusion criteria

Exclusion Criteria:

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

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
264 participants (estimated)

Study arms

  • Experimental
    Dexamethasone with lignocaine

    Drug: Dexamethasone

Interventions

  • Steroids and analgesics

    Also known as: Lignocaine

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What researchers measure

Primary outcomes

  1. Tinnitus relief

    Tinnitus relief ascertained by Modified Tinnitus Handicap Inventory

    Time frame: 2 weeks

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Study locations

1 site
  • Combined Military Hospital
    Quetta, Balochistan 1234, Pakistan
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04798391
Lead sponsor
Combined Military Hospital, Pakistan
Responsible party
FARAH AFZAL (CLASSIFIED SPECIALIST, Combined Military Hospital, Pakistan) — Principal investigator
First posted
Mar 15, 2021
Start date
Mar 1, 2021
Primary completion
Apr 2021 (estimated)
Completion
May 2021 (estimated)
Last update
Mar 15, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Dexamethasone

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