'Inner Ear Support' Oral Capsule in Patients With Sudden Sensorineural Hearing Loss
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFar East Bio-Tec Co., Ltd
About this trial
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 people of any age, though it is more common among adults aged 40 to 60. In many cases, the exact cause remains unknown, but possible reasons include viral infections, immune-related problems, and reduced blood circulation to the inner ear. Along with hearing loss, many patients may also experience tinnitus (ringing in the ears) or dizziness.
The standard treatment for SSNHL often involves steroids, sometimes combined with hyperbaric oxygen therapy. However, the effectiveness of these treatments varies, and many patients do not fully recover their hearing. This study aims to explore whether an additional supplement-'Inner ear support' oral capsule-can improve hearing outcomes and relieve associated symptoms in patients with SSNHL.
The study will involve 80 participants who are randomly assigned to two groups. Both groups will receive standard treatment (including steroids and possibly hyperbaric oxygen therapy), but only the test group will take the 'Inner ear support' capsule twice daily for 28 days. Participants will be followed and evaluated over a period of 196 days through hearing tests and symptom questionnaires.
'Inner ear support' is a commercially available nutritional supplement that includes FB-1603 (an extract from Arthrospira maxima), GABA, gamma-oryzanol, and sesamin. Previous research has shown that FB-1603 and its active component, C-phycocyanin, have anti-inflammatory, antioxidant, and nerve-protective effects. Animal studies suggest it may help reduce tinnitus and prevent hearing deterioration.
This clinical trial is designed to evaluate whether 'Inner ear support' can enhance hearing recovery, improve tinnitus and dizziness symptoms, and be safely used as an additional treatment in patients with sudden hearing loss. All participants will be monitored for any potential side effects during the study period.
The ultimate goal of this study is to determine whether' Inner ear support' could become a helpful addition to current treatment methods for SSNHL, improving patient outcomes and quality of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Inner ear support
Dietary supplementFB-1603 (150 mg): A cold water extract of Arthrospira maxima (a species of blue-green algae), rich in the antioxidant pigment C-phycocyanin (C-PC). GABA (126 mg): A natural calming neurotransmitter that can help reduce nerve-related overactivity. γ-Oryzanol (12 mg): A component from rice bran oil, known for its antioxidant properties. Sesamin (12 mg): A compound from sesame seeds, with potential neuroprotective and anti-inflammatory benefits.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: stand treatmentNo intervention 0 interventions
Group B: stand treatment +Inner ear supportExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes in pure tone audiometry (PTA)
Changes in pure tone audiometry (PTA) results at V2 (Day 28), V3 (Day 84), and V4 (Day 168) compared to baseline.
Time frame
Baseline (Day 0), V2 (Day 28), V3 (Day 84), and V4 (Day 168)Secondary outcomes
1
Change in AST (Aspartate Transaminase) level from baseline
Mean change in serum AST level (U/L) from baseline to V2 (Day 28), V3 (Day 84), and V4 (Day 168).
Time frame
Baseline (Day 0), V2 (Day 28), V3 (Day 84), and V4 (Day 168)2
Change in ALT (Alanine Transaminase) level from baseline
Mean change in serum ALT level (U/L) from baseline to V2, V3, and V4.
Time frame
Baseline (Day 0), V2 (Day 28), V3 (Day 84), and V4 (Day 168)3
Change in serum albumin level from baseline
Mean change in serum albumin concentration (g/dL) from baseline to V2, V3, and V4.
Time frame
Baseline (Day 0), V2 (Day 28), V3 (Day 84), and V4 (Day 168)4
Change in alkaline phosphatase (Alk-P) level from baseline
Mean change in serum alkaline phosphatase level (U/L) from baseline to V2, V3, and V4.
Time frame
Baseline (Day 0), V2 (Day 28), V3 (Day 84), and V4 (Day 168)Sponsors and contacts
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Source ClinicalTrials.gov
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