Status:
NOT_YET_RECRUITING
'Inner Ear Support' Oral Capsule in Patients With Sudden Sensorineural Hearing Loss
Lead Sponsor:
Far East Bio-Tec Co., Ltd
Conditions:
Sudden Sensorineural Hearing Loss (SSNHL)
Tinnitus
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Sudden sensorineural hearing loss (SSNHL) is a medical condition where people experience rapid hearing loss, usually in one ear, over a short period of time (typically within 72 hours). It can affect ...
Detailed Description
Sudden sensorineural hearing loss (SSNHL) is an otologic emergency characterized by rapid onset of hearing loss, typically unilateral, occurring over less than 72 hours. The annual incidence is estima...
Eligibility Criteria
Inclusion
- Patients aged between 18 and 75 years
- Patients diagnosed with sudden sensorineural hearing loss as determined by the principal or sub-investigator
- Average hearing threshold in the affected ear ≥ 60 dB
- Initiation of treatment within two weeks of hearing loss onset
Exclusion
- Patients with congenital or hereditary hearing loss
- Patients with fluctuating hearing loss
- Patients currently participating in other interventional treatments for sudden hearing loss
- Patients who have undergone surgery on the affected ear
- Patients with neurological or psychiatric disorders
- Patients with heart failure or ischemic heart disease
- Patients with immunodeficiency
- Patients with vestibular schwannoma (acoustic neuroma)
- Patients with other internal medical conditions deemed by the investigator to potentially interfere with the study conduct or outcomes
- Pregnant patients
- Patients with a known allergy to the investigational product
- Patients currently using acetylcysteine or products containing ginkgo biloba extract
- Patients with autoimmune diseases or currently receiving immunosuppressive therapy
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06997406
Start Date
June 1 2025
End Date
June 30 2026
Last Update
May 30 2025
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan