ISRCTN38408464
Completed
未知
Pragmatic trial to assess the possibility of enhancing the effectiveness of tinnitus retraining therapy (TRT) by concomitant treatment with Ginkgo Biloba extract EGb 761® in patients with chronic tinnitus
Dr. Willmar Schwabe GmbH & Co. KG (Germany)0 sites300 target enrollmentJune 6, 2014
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Chronic Tinnitus
- Sponsor
- Dr. Willmar Schwabe GmbH & Co. KG (Germany)
- Enrollment
- 300
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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