KCT0006636
Recruiting
未知
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
ConditionsDiseases of the ear and mastoid process
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the ear and mastoid process
- Sponsor
- WONTECH
- Enrollment
- 56
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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