Monocentric, prospective, randomized placebo-controlled double-blind phase II trial exploring protective effects of Ginkgo biloba special extract EGb 761® against noise-induced temporary hearing impairment
- Conditions
- oise induced hearing impairment
- Registration Number
- DRKS00006173
- Lead Sponsor
- Dr. Willmar Schwabe GmbH &Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 202
1. healthy men aged between 18 and 25 years with normal hearing ability
2. written informed consent
3. Readiness and ability to take part in all study specific measures
1.History of hearing impairment, acute hearing loss or acoustic trauma
2.Tinnitus
3.Estimated noise exposure (work/leisure) above the threshold of 85 dB SPL (Sound Pressure Level) on average over a period of 8 hours 5 days a week
4.Disorder of the external, middle or inner ear or hearing impairment, e.g. middle ear infusion, tubal ventilation disorder, ear surgery performed, lying vent tube stated at screening
5.Hemorrhagic diathesis, coagulation disorder
6.Conditions which may impair resorption
7.Chronic, serious or acute general disorder within the last 4 weeks
8.Hypersensitivity to one of the ingredients of the study drug
9.Acute or chronic otologic, neurologic or psychiatric disease during the last 12 months
10.Clinically relevant internal disease with the exception of
a) sufficient and stable treatment of thyroid function disorder or struma
11.Presence of clinically significant ECG or laboratory abnormalities
12.Current substance abuse or addiction or history thereof
13.Participation in another clinical trial during the past 12 weeks
14.Regular intake of drugs, dietary supplements, vitamin or mineral supplements with the exception of
a) Thyroid hormone treatments
15.Concomitant medication from one of the following types of substances:
a) systemic corticosteroids
b) ASA (acetylsalicylic acid) or NSAR (non-steroidal anti rheumatics)
c) potentially ototoxic antibiotics
d) platelet aggregation inhibitors or anticoagulants
e) psychotropic drugs (antidepressants, anxiolytics, tranquilizers, hypnotics)
f) phytopharmaceuticals or herbal food supplements
g) mineral or vitamin supplements
h) antihistamines or antiemetics having an effect on the central nervous system (CNS)
16.Intake of any preparation Ginkgo biloba within the last 8 weeks
17.Planned surgery or hospital stay during study
18.Other factors which call into question the study participation (e.g. lack of understanding of nature and scope of the study, insufficient knowledge of German language)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Average increase of the audiometric hearing threshold at frequencies 3,4,6,8,10, 11.2 and 12.5 KH 1 to 8 minutes after end of noise exposure
- Secondary Outcome Measures
Name Time Method 1 to 8 minutes after end of noise exposure<br>Decrease of the amplitude of distortion product otoacoustic emissions (DPOAE)<br><br>Decrease of the contralateral suppression of the distorsively produced otoacoustic emissions (DPOAEs).<br><br>Decrease of the click-evoked OAE-amplitude (broad band).<br><br>After 4 weeks:<br>Proportion of healthy volunteers with increase of hearing threshold> 5 dB at frequences 3,4,6,8,10,11.2 or 12.5 kHz measured by means of pure tone audiometry.<br><br>Decrease of the distortion product OAE amplitude.<br>Decrease of the contralateral suppression of the DPOAEs<br>Decrease of the click-evoked OAE amplitude (broad band).<br><br>Adverse envents