Status:
COMPLETED
A Study on the Effectiveness of Antioxidant Supplementation in Tinnitus
Lead Sponsor:
National and Kapodistrian University of Athens
Conditions:
Tinnitus
Eligibility:
All Genders
25-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the effectiveness of antioxidant supplementation in idiopathic tinnitus patients. To investigate this, a double-blind, randomized, and placebo-controlled clinic...
Eligibility Criteria
Inclusion
- Age 25-75 years old
- Unilateral or bilateral chronic idiopathic persistent tinnitus of at least 6 months' duration
- Tinnitus Handicap Inventory score rated ≥ 4 at baseline
- With a normal audiogram or up to medium-grade neurosensory hearing loss.
- Tinnitus maskable (by noise masking) with noise at least 5 decibel
- Childbearing age with a negative pregnancy test at eligibility and baseline assessment
- Stable medication during the whole period of the 3-month intervention
- Willing and able to attend the on-study visits
- Able to read and understand the relevant study documents and rating scales and follow investigator instructions during audiologic measurements
Exclusion
- Tinnitus following acute acoustic trauma, sudden deafness or traumatic head or neck injury
- Intermittent tinnitus
- Meniere's Disease, otosclerosis, acute or chronic otitis media
- Head and neck radiotherapy
- Active GI disease; active malignant diseases; autoimmune diseases; cardiovascular disease; renal or hepatic disorders; haemorrhagic diathesis
- Intake of anticoagulants; ototoxic medications; tinnitus-inducing medication (e.g. aminoglycosides, chemotherapeutics, loop diuretics, high doses of aspirin or quinine)
- Psychiatric disorders
- Unregulated diabetes mellitus, hypertension or thyroid disease
- Alcohol or drug abuse
- Vitamin or inorganic supplements, vegan or macrobiotic diet before and during the trial
- Pregnancy, lactation
Key Trial Info
Start Date :
January 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04105426
Start Date
January 10 2019
End Date
May 25 2019
Last Update
November 13 2019
Active Locations (1)
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1
General Hospital of Athens "Hippocratio", Department of Otorhinolaryngology
Athens, Greece