Healthy adults
Conditions
Interventions
Ingestion of capsules containing Oligonol daily for 4 weeks.
Ingestion of placebo capsules daily for 4 weeks.
Sponsors
Hokkaido Information University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects with slight tinnitus. 2. Subjects with relatively high THI scores (selected via screening). 3. Subjects who agree to participate in this study with a written informed consent.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tinnitus Handicap Inventory (THI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analog Scale (VAS) score for subjective symptoms, temperature of tympanum, peripheral blood flow and blood pressure at visit | — |
Countries
Japan
Contacts
Public ContactDir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Hokkaido Information University Health Information Science Center
Outcome results
None listed