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Effect of sodium valproate on reduction of tinnitus in patients with Meniere's disease

Effect of sodium valproate on reduction of tinnitus in patients with Meniere's disease: a pilot study

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240504061648N1
Enrollment
25
Registered
2025-02-26
Start date
2025-02-19
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

Condition 1: Tinnitus. Condition 2: Meniere's disease. Tinnitus Meniere's disease

Interventions

Intervention group: 25 patients with Meniere's disease are selected using convenience sampling. Subjects are compared at baseline and after treatment. The audiometric instrument used is the Tinnitus H

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Confirming the diagnosis of Meniere's disease based on history and physical examination and audiometry Age 18 to 80 years

Exclusion criteria

Exclusion criteria: Pregnant or lactating women Diagnosis of other central or peripheral vestibular disorders, such as vestibular migraine, benign postural vertigo, paroxysmal brainstem attacks, and postural phobic vertigo. Patients with contraindications or sensitivity to betahistins, such as bronchial asthma, pheochromocytoma Treatment with other antihistamines Severe liver or kidney failure Severe coronary heart disease or heart failure, persistent uncontrolled hypertension with systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg The presence of contraindications for the use of sodium valproate History of genetic disorders of the urea cycle Participating in another trial in the past 30 days

Design outcomes

Primary

MeasureTime frame
Severity of Tinnitus. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the intervention (3 months after the start of the intervention). Method of measurement: Audiometry and Tinnitus Handicap Inventory.;Adverse events. Timepoint: At the duration of the study and at the end of the intervention (3 months after the start of the intervention). Method of measurement: Adverse events checklist.

Secondary

MeasureTime frame
Patient satisfaction. Timepoint: At the end of the intervention (3 months after the start of the intervention). Method of measurement: Using a 3-point Likert scale (satisfied-moderate-dissatisfied).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactYalda Jabbari

Tabriz University of Medical Sciences

salehiha@tbzmed.ac.ir+98 41 3334 2219

Outcome results

None listed

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