'Inner Ear Support' Oral Capsule in Patients With Sudden Sensorineural Hearing Loss
A legfontosabb adatok
- Ki végzi
- Far East Bio-Tec Co., Ltd
- Hol
- Taipei (Tajvan)A helyszín megnézése
- Azonosító
- Állapot
- Toborzás még nem indult
- Résztvevők
- 80 fő, tervezett
- Kezdés
- 2025. jún. 1.
- Tervezett befejezés
- 2026. jún. 30.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport nem kap vizsgálati kezelést, összehasonlításként.
- A vizsgált kezelések
- Inner ear support
- A regiszteradat frissítve
- 2025. május 30.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
The trial is looking for adults with sudden hearing loss of the inner ear or hearing nerve (sudden sensorineural hearing loss). All get standard treatment, and some also take the 'Inner ear support' capsule.
- Életkor
- 18 to 75 years
- Nem
- All sexes
- A betegség stádiuma
- Sudden sensorineural hearing loss confirmed by the study doctor. Average hearing threshold in the affected ear of ≥ 60 dB. Treatment must start within two weeks of the hearing loss starting.
- Korábbi kezelés
- People who had surgery on the affected ear cannot join. People taking part in other treatment studies for sudden hearing loss cannot join.
A részvétel fő kizáró okai
- Hearing loss present from birth or inherited, or hearing loss that comes and goes
- Neurological or psychiatric disorders, heart failure or ischemic heart disease
- Weak immune system, autoimmune disease, or current immunosuppressive therapy
- Vestibular schwannoma (acoustic neuroma), or pregnancy
- Current use of acetylcysteine or ginkgo biloba products, or allergy to the study product
A regiszter feltételei, szó szerint
Mind a 17 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- Patients who have undergone surgery on the affected ear
- 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
- Patients with neurological or psychiatric disorders
- Patients with heart failure or ischemic heart disease
- Patients with other internal medical conditions deemed by the investigator to potentially interfere with the study conduct or outcomes
- Patients with congenital or hereditary hearing loss
- Patients with fluctuating hearing loss
- Patients currently participating in other interventional treatments for sudden hearing loss
- Patients with immunodeficiency
- Patients with vestibular schwannoma (acoustic neuroma)
- Pregnant patients
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 75 év között vagy?
Helyszínek itt: Tajvan
- National Taiwan University HospitalTaipei, TajvanContact: Pei-Hsuan Lin, P.h.DNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A teljes eredeti leírásKevesebb
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.
A vizsgálat 2 csoportja
- stand treatmentNincs vizsgálati kezelés, összehasonlításként
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 supportA vizsgált kezelés
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).
Kezelés: Inner ear support
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Explore the Benefit of 'Inner Ear Support' Oral Capsule in Patients With Sudden Sensorineural Hearing Loss - A Randomized, Open-label, Single-center Study
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
- Illeszkedési kérdések
- Forrás: NCT06997406: ki vehet részt
- A regiszteradat frissítve
- 2025. május 30.