The objective of this prospective randomized and double blind controlled study is to evaluate the efficacy and safety of Sulodexide (25 mg) in the treatment of chronic idiopathic subjective tinnitus.
Patients with chronic idiopathic subjective tinnitus, since at least 1 year, re recruited from our Ear, Nose and Throat (ENT) clinic. After verification of inclusion and exclusion criteria, patients consenting to enter the study are assigned randomly to one of the following groups: 1- Sulodexide 25 mg for 40 days 2- Placebo for 40 days. Clinical evaluation of the patient is performed; tinnitus is assessed according to Tinnitus Handicap Inventory score, Mini Tinnitus Questionnaire score. Adverse effects are also noted. Patients are followed at 40 days post-treatment and outcome measures are assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
126
25 mg morning and evening for 40 days
1 tablet morning and evening for 40 days
St Jospeh University
Beirut, Lebanon
Tinnitus Handicap Inventory (THI)
Assessment of changes in THI questionnaire score between Day 40 and 0
Time frame: At day 0 and at 40 days
Mini Tinnitus Questionnaire (Mini-TQ)
Assessment of changes in Mini-TQ questionnaire score between Day 40 and 0
Time frame: At day 0 and at 40 days
Adverse effects
reporting adverse effects by the patient
Time frame: Up to 40 days
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