Chronic Tinnitus Ear, Nose and Throat Tinnitus
Conditions
Interventions
The trial will involve 300 outpatients (male and female) at 5-10 trial sites (ENT specialists) in Switzerland. Trial duration per patient is 6 months up to 12 months, if the participant agrees to a 6
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Outpatients aged = 30 with unilateral or bilateral, chronic tinnitus (duration more than 3 months) 2. Tinnitus in the context of hearing loss, noise or mental stress 3. Tinnitus is the main complaint; other cochlear or vestibular symptoms may be present but less annoying 4. Tinnitus stage according to Biesinger 2 or higher at baseline 5. Written informed consent to participate in the clinical trial, to randomised treatment allocation and to data recording in accordance with applicable laws. Participants must be of age and they shall be able to realize the character, importance and consequences of the clinical trial and to align their volition with it.
Exclusion criteria
Exclusion criteria: 1. Participation in another experimental drug trial at the same time or within the past 4 weeks before enrolment 2. Any treatments for tinnitus taken currently or within 4 weeks before randomisation 3. Acute or chronic otitis media or vestibular neuritis 4. Drug-induced tinnitus 5. Ongoing psychiatric disorder, such as major depression, generalized anxiety disorder, schizophrenia, etc Of note: Symptoms of depression or anxiety or other behavioural or psychological symptoms at sub-syndromal level and not requiring treatment with psychotropic drugs are permitted. 6. Severe cardiac or circulatory disorder - severe (Canadian Cardiovascular Society stage IV) or unstable angina pectoris - decompensated congestive heart failure (NYHA stage IV) - uncontrolled hypertension with systolic blood pressure above 180 mmHg and/or diastolic blood pressure above 115 mmHg - clinically significant cardiac arrhythmias (Lown classes IVb and V, bifascicular bundle branch block). 7. Severe renal or hepatic dysfunction (serum creatinine or serum ASAT, ALAT or gamma-GT above 3 times the upper limit of the reference range) or coagulation disorder 8. Insulin-dependent diabetes mellitus 9. Intake of drugs not permitted during participation in the study, in particular, insulin, psychoactive drugs, perfusion-enhancing drugs, cognition enhancing drugs or anti-cholinergic drugs (for details see section 6) 10. Active malignant disease (exception: prostate cancer which does not require other than hormone treatment within the next 6 months) 11. Known hypersensitivity to Ginkgo biloba extract or to excipients contained in the tablets 12. Active peptic ulcer disease or any gastrointestinal disease with potential impairment of the absorption of orally applied drugs (e.g. Billroth I/II, Crohn's disease, ulcerative colitis, any kind of enterectomy) 13. Female patients, who are pregnant, breast-feeding or of childbearing potential without safe contraception (hormonal contraception, oral or transdermal, and intra-uterine devices are considered sufficiently safe; child-bearing potential can be denied in case of postmenopausal state for at least 2 years, hysterectomy, bilateral tubal ligation or bilateral oophorectomy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Due to the trial hypothesis no differentiation between primary and secondary outcome variables is made. Outcome variables: 1. Pure tone and speech audiometry 2. Tinnitus Questionnaire (TQ) 3. Hospital Anxiety and Depression Scale (HADS) 4. Perceived Stress Questionnaire (PSQ) 5. Sheehan Disability Scale (SDS) 6. Hyperacusis Questionnaire (GÜF) 7. 11-Point Box Scales for tinnitus loudness and annoyance | — |
Secondary
| Measure | Time frame |
|---|---|
| See above | — |
Countries
Switzerland
Outcome results
None listed