KCT0006636Recruiting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
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- WONTECH
- Enrollment
- 56
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 19?(Year) to 0No Limit (—)
- Sex
- All
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
Investigators
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