A clinical trial designed to verify the effectiveness of a low-level medical laser apparatus TINI” in improving tinnitus symptoms of chronic high-frequency tinnitus patients

WONTECH0 个研究点目标入组 56 人开始时间: 待定最近更新: 2022年3月8日

适应症

试验速览

暂无简介。

•1. Aged = 19 years
•2. Unilateral subjective tinnitus symptoms for more than 3 months (If the subject has bilateral tinnitus, subject who has dominant symptom between two ears could be enrolled.)
•3. A person with a tinnitogram of at least 4 kHz tinnitus frequency
•4. Consent to and willing to discontinue medication for tinnitus (eg, Ginkgo-Biloba, Tanamin, etc.) during this trial
•5. Women of childbearing age who are confirmed by negative in pregnancy test and who agree to use the contraceptive device during the study
•6. Those who agree not to receive any treatment on the ear during the period of clinical trial participation
•7. Those who voluntarily participate in the trial and are willing to follow the protocol
•8. Those who have fully understood the written consensus

•1. In the cases that the tinnitus has definite cuase (acoustic neurinoma, cerebral tumor, cerebral vessel malformation, vascular tinnitus, tinnitus induced by muscle contraction)
•2. Those with history of conductive hearing loss, perforation of the eardrum, etc.
•3. Experiences of ototoxic drugs, those who have had meningitis
•4. Those who have ear diseases such as external otitis, ear canal occlusion, otitis media
•5. Any person who has had a serious disease in cardiovascular, digestive, respiratory, endocrine, or central nervous system, or a mental illness
•6. Anyone who is sensitive to light
•7. Women of childbearing age who do not agree to contraception during the study
•8. Pregnant women or nursing woman
•9. Persons who participated in other clinical trials within 30 days prior to screening
•10. Other persons deemed inappropriate to participate in this clinical trial at the discretion of the researcher

发起方