'Inner Ear Support' Oral Capsule in Patients With Sudden Sensorineural Hearing Loss

NCT06997406 | Not Yet Recruiting

• 1 other identifier: FE-NTUH-FB1603
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Sudden Sensorineural Hearing Loss (SSNHL); Tinnitus

Keywords

Sudden Sensorineural Hearing Loss; SSNHL; C-phycocyanin; Tinnitus; Hearing Recovery; Inner Ear Support; Arthrospira; herbal medicine

Outcome Measures

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.

  Baseline (Day 0), V2 (Day 28), V3 (Day 84), and V4 (Day 168)

Secondary Outcomes (8)

• Change in AST (Aspartate Transaminase) level from baseline

  Baseline (Day 0), V2 (Day 28), V3 (Day 84), and V4 (Day 168)

• Change in ALT (Alanine Transaminase) level from baseline

  Baseline (Day 0), V2 (Day 28), V3 (Day 84), and V4 (Day 168)

• Change in serum albumin level from baseline

  Baseline (Day 0), V2 (Day 28), V3 (Day 84), and V4 (Day 168)

• Change in alkaline phosphatase (Alk-P) level from baseline

  Baseline (Day 0), V2 (Day 28), V3 (Day 84), and V4 (Day 168)

• Change in gamma-glutamyl transpeptidase (GGT) level from baseline

  Baseline (Day 0), V2 (Day 28), V3 (Day 84), and V4 (Day 168)

Study Arms (2)

stand treatment

NO INTERVENTION

Based on clinical symptoms and the patient's physical condition, standard treatment will be provided, including the use of steroids (oral and/or intratympanic injection) and hyperbaric oxygen therapy.

stand treatment +Inner ear support

EXPERIMENTAL

Based on clinical symptoms and the patient's physical condition, standard treatment will be provided, including the use of steroids (oral and/or intratympanic injection) and hyperbaric oxygen therapy. In addition, subjects will take 'Inner ear support' oral capsules in the morning and evening (600 mg per dose, 1200 mg per day).

Dietary Supplement: Inner ear support

Interventions

Inner ear support DIETARY_SUPPLEMENT

FB-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.

stand treatment +Inner ear support

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Far East Bio-Tec Co., Ltd: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Hearing Loss, Sudden; Tinnitus

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pei-Hsuan Lin, P.h.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shawn Chen, Ph.D.

CONTACT

+886 2 2655-8198; mrx1025@hotmail.com

Chris Ho, Master

CONTACT

+886 2 2627-5585; rdrad001@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 30, 2025
• Study Start: June 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

TW (1)