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

Phase 3

Recruiting

Conditions: Tinnitus.
Tinnitus, unspecified ear
H93.19

Registration Number: IRCT20240420061531N1

Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Male

Target Recruitment: 120

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

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.