[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Far East Bio-Tec Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":81},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100592743","inner-ear-support-oral-capsule-in-patients-with-sudden-sensorineural-hearing-loss-100592743",false,"NCT06997406","'Inner Ear Support' Oral Capsule in Patients With Sudden Sensorineural Hearing Loss","Explore the Benefit of 'Inner Ear Support' Oral Capsule in Patients With Sudden Sensorineural Hearing Loss - A Randomized, Open-label, Single-center Study","Inclusion Criteria:\n\n* Patients aged between 18 and 75 years\n* Patients diagnosed with sudden sensorineural hearing loss as determined by the principal or sub-investigator\n* Average hearing threshold in the affected ear ≥ 60 dB\n* Initiation of treatment within two weeks of hearing loss onset\n\nExclusion Criteria:\n\n* Patients with congenital or hereditary hearing loss\n* Patients with fluctuating hearing loss\n* Patients currently participating in other interventional treatments for sudden hearing loss\n* Patients who have undergone surgery on the affected ear\n* Patients with neurological or psychiatric disorders\n* Patients with heart failure or ischemic heart disease\n* Patients with immunodeficiency\n* Patients with vestibular schwannoma (acoustic neuroma)\n* Patients with other internal medical conditions deemed by the investigator to potentially interfere with the study conduct or outcomes\n* Pregnant patients\n* Patients with a known allergy to the investigational product\n* Patients currently using acetylcysteine or products containing ginkgo biloba extract\n* Patients with autoimmune diseases or currently receiving immunosuppressive therapy","ALL","18 Years","75 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.\n\nThe 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.\n\nThe 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.\n\n'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.\n\nThis 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.\n\nThe 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.",[27,28],"Sudden Sensorineural Hearing Loss (SSNHL)","Tinnitus",[30,31,32,28,33,34,35,36],"Sudden Sensorineural Hearing Loss","SSNHL","C-phycocyanin","Hearing Recovery","Inner Ear Support","Arthrospira","herbal medicine","NOT_YET_RECRUITING","2025-05-21",{"date":40,"type":41},"2025-05-30","ACTUAL",{"date":43,"type":21},"2025-06-01",{"date":45,"type":21},"2026-06-30",{"name":47,"class":48},"Far East Bio-Tec Co., Ltd","INDUSTRY",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":49},"100184535","phase-2-study-to-investigate-the-efficacy-and-safety-of-apomivir-100184535","NCT01677689","Study to Investigate the Efficacy and Safety of Apomivir®","A Prospective, Randomized, Double-blind, Parallel, Placebo-controlled, Multi-center Study to Investigate the Efficacy and Safety of Apomivir® in Relieving Influenza Symptoms","1\\. Main inclusion criteria:\n\n1. Females and males aged between 20 and 65\n2. Presumptive diagnosis of influenza based on the following clinical characteristics:\n\n   * Present at least one respiratory symptom (e.g. cough, nasal obstruction, sore throat) and at least one constitutional symptom other than fever (e.g. fatigue, headache, myalgias) of less than 48-hour duration\n   * Positive for influenza A or B (nasopharyngeal\u002Fthroat swab - rapid test)\n3. Able and willing to comply with the study procedure and give written informed consent\n\n2\\. Main exclusion criteria:\n\n1. Female who is pregnant\u002Flactating or planning to be pregnant, or female of childbearing potential\\* who is not using medically recognized method of contraception\n\n   \\* Other than those who have been surgically sterilized (defined as having undergone hysterectomy or bilateral oophorectomy or bilateral salpingectomy; tubal ligation alone is not considered sufficient) or one year post-menopausal\n2. Subject with chronic pulmonary diseases or critical condition or already developed severe respiratory distress with hypoxaemia on presentation\n3. Subject with a history of non-febrile convulsions, neuromuscular disorders or cognitive dysfunction that may compromise respiratory secretions, or who are currently receiving anticonvulsive agents\n4. Subject with clinically important illness, malignancies, systemic infection, other medical or psychiatric condition which places the subject at unacceptable risk to participate in the study or confounds the ability to interpret data from the study\n5. Subject with significant abnormal laboratory findings (hemoglobin level \\\u003C 9.0 g\u002FdL, WBC \\\u003C 4000\u002Fmm3, platelet count \\\u003C 100,000\u002Fmm3, ALT or AST \\> 2.5 x upper limit of normal (ULN), or estimated creatinine clearance \\\u003C 30 mL\u002Fmin within 4 weeks prior to baseline)\n6. Subject who are currently receiving immunosuppressive therapy,\n7. Subject has taken daily supplement(s) containing blue agar within 1 month prior to screening, or any other medication that may affect the study results\n8. Known hypersensitivity to any ingredients in Apomivir® or other blue agar\n9. Use of any investigational product within 1 month prior to screening","20 Years","65 Years",{"count":60,"type":21},196,[62],"PHASE2","Apomivir® is extracted from a proprietary spirulina strain, FEM-101, a kind of blue cyanobacterium with patented freeze-thaw lysis and extraction method. According to the preclinical studies, Apomivir® have been proven to have excellent broad-spectrum anti-viral ability, especially for seasonal influenza viruses (Influenza virus A and B) that may cause illness, paralysis and even death, especially in children and elderly people. This phase II study is designed to evaluate the efficacy and safety of Apomivir® (120 mg b.i.d.) in subjects with seasonal influenza.",[65],"Influenza",[67,68,69,70,71,72],"oral temperature","respiratory symptom","cough","nasal obstruction","sore throat","fever","2025-05-12",{"date":75,"type":41},"2025-05-14",{"date":77,"type":21},"2026-05-31",{"date":79,"type":21},"2027-12-31",{"name":47,"class":48},""]