JPRN-UMIN000020950已完成未知
A Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Usefulness of Oligonol for Hearing Discomfort - Evaluation of Usefulness of Oligonol for Hearing Discomfort
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 70years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Subjects who are under physician's advice, treatment and/or medication for tinnitus. 2. Subjects who are under physician's treatment and/or medication for ear disorders such as Sudden Sensorineural Hearing Loss (SSHL), acoustic neuroma, Meniere's disease, otitis media, otosclerosis, otitis externa, etc. or who have a history of severe ear disorder(s). 3. Subjects who have been operated upon cochlear implant, meatoplasty, tympanoplasty, stapes surgery, etc. 4. Subjects who wear hearing-support device(s). 5. Subject whose THI scores are >=58 6. Subjects who are under treatment and medication for psychiatric disorders. 7. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, disorder of endocrine and metabolism or affected with infectious diseases which are required to report to the authorities. 8. Subjects who have a history of gastrectomy, gastrorrhaphy, enterectomy and/ or other serious gastrointestinal surgeries. 9. Subjects with unusually high and/or low blood pressure, or with abnormal hematological data. 10. Subjects who have a severe anemia. 11. Pre- or post-menopausal women having obvious changes in physical condition. 12. Subjects who have a history of allergy or sensitivity to medicine and / or food (especially lychees, tea, gelatin and pork). 13. Subjects who regularly take drugs, functional foods and/or supplements which may relieve tinnitus. 14. Heavy smokers, alcohol addicts or subjects with irregular lifestyle. 15. Subjects who donate either 400 ml whole blood within 12 weeks or 200 ml whole blood within 4 weeks or blood components within 2 weeks prior to this study. 16. Pregnant or lactating women or women expect to be pregnant during the study. 17. Subjects who participate in other clinical trials within the last one month prior to this study. 18. Any other medical reasons judged by the doctor-in-charge.
研究者
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