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Investigating the effectiveness of intratympanic injection of lidocaine and dexamethasone separately in the treatment of idiopathic tinnitus

Investigating the effectiveness of intratympanic injection of lidocaine and dexamethasone separately in the treatment of idiopathic tinnitus in Loghman hospital in 1403

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240420061531N1
Enrollment
120
Registered
2024-05-17
Start date
2024-05-21
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus. Tinnitus, unspecified ear

Interventions

Intervention 1: intervention group: intratympanic injection of dexamethasone. In the first intervention group, which is a group of 40 people, they are subjected to intratympanic injection of dexametha

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Patients with tinnitus referred to Luqman educational-therapeutic-research center in 2024 Patients who cannot find a cause for their tinnitus Patients who include tinnitus and without concomitant disease such as rupture of the eardrum, a history of ear surgery, otosclerosis, Cerebellopontine angle tumor, ear trauma, disorders of internal systems such as hypothyroidism,Monocular hearing, diabetes and genetic disorders.

Exclusion criteria

Exclusion criteria: Patients who are excluded from the study for any reason during the research or follow-up is not possible. Patients who do not complete the full follow-up of the study (follow-up within 3 months). Patients who are excluded from the study due to possible complications.

Design outcomes

Primary

MeasureTime frame
Tinnitus reduction in tinnitus handicap inventory (6 to 8 marks). Timepoint: In the period of the first 2 weeks after the injections and 1 month and 3 months later. First, before the start of the injections, at the beginning of the study, then at the end of 2 weeks, 1 month and 3 months. It is measured 4 times overall. Method of measurement: THI (tinnitus handicap inventory) questionnaire to measure tinnitus. Tinnitus handicap inventory is a 25-item questionnaire to determine the severity of tinnitus disability, which psychometrics have been proven in studies. The 25 items of the questionnaire are classified into three functional, emotional and catastrophic subscales.

Secondary

MeasureTime frame
Tympanic membrane perforation. Timepoint: In the first 2 weeks and 3 months later. It is checked twice in the study. Method of measurement: Examination under the microscope.;Hearing loss. Timepoint: In the first 2 weeks and 3 months later. It is checked twice in the study. Method of measurement: Audiogram.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactGhaem Khodabakhsh

Shahid Beheshti University of Medical Sciences

ghaemkhodabakhsh@yahoo.com+98 21 5541 9005

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026