Sulodexide Efficacy in Chronic Idiopathic Subjective Tinnitus

Randomized Double Blind Controlled Trial on Sulodexide Efficacy in Chronic Idiopathic Subjective Tinnitus

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02737670

Acronym

SECIST

Enrollment

126

Registered

2016-04-14

Start date

2014-08-31

Completion date

2017-08-31

Last updated

2017-09-14

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

Conditions

Tinnitus, Subjective

Brief summary

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.

Detailed description

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.

Interventions

DRUGPlacebo

1 tablet morning and evening for 40 days

DRUGSulodexide

25 mg morning and evening for 40 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Tinnitus for minimum of 1 year * Absence of psychiatric or neurological diseases * Absence of any disease that explains tinnitus * Noise-induced hearing loss * Cochlear and retro-cochlear damage

Exclusion criteria

* Conductive hearing loss * Mixed hearing loss * Meniere's disease * Systemic vascular disease * Diabetic disease * Vestibular schwannoma * Cerebello-pontine angle tumors * Pulsatile tinnitus * Pregnancy

Design outcomes

Primary

Measure	Time frame	Description
Tinnitus Handicap Inventory (THI)	At day 0 and at 40 days	Assessment of changes in THI questionnaire score between Day 40 and 0

Secondary

Measure	Time frame	Description
Mini Tinnitus Questionnaire (Mini-TQ)	At day 0 and at 40 days	Assessment of changes in Mini-TQ questionnaire score between Day 40 and 0
Adverse effects	Up to 40 days	reporting adverse effects by the patient

Countries

Lebanon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026