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Effectiveness of Intratympanic Dexamethasone With Ligmocaine for Alleviation of Tinnitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04798391
Recruitment Status : Unknown
Verified March 2021 by FARAH AFZAL, Combined Military Hospital, Pakistan.
Recruitment status was:  Active, not recruiting
First Posted : March 15, 2021
Last Update Posted : March 15, 2021
Sponsor:
Information provided by (Responsible Party):
FARAH AFZAL, Combined Military Hospital, Pakistan

Study Description
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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.


Condition or disease Intervention/treatment Phase
Tinnitus Drug: Dexamethasone Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Dexamethasone With Lignocaine for Alleviation of Tinnitus
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dexamethasone with lignocaine Drug: Dexamethasone
Steroids and analgesics
Other Name: Lignocaine


Outcome Measures
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Primary Outcome Measures :
  1. Tinnitus relief [ Time Frame: 2 weeks ]
    Tinnitus relief ascertained by Modified Tinnitus Handicap Inventory


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • score 20 or above on modified tinnitus handicap inventory

Exclusion Criteria:

  • head trauma, tympanic membrane perforation, depression, ear surgery
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04798391


Locations
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Pakistan
Combined Military Hospital
Quetta, Balochistan, Pakistan, 1234
Sponsors and Collaborators
Combined Military Hospital, Pakistan
More Information
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Responsible Party: FARAH AFZAL, CLASSIFIED SPECIALIST, Combined Military Hospital, Pakistan
ClinicalTrials.gov Identifier: NCT04798391    
Other Study ID Numbers: CMHQ
First Posted: March 15, 2021    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents