Healthy Japanese subjects
Conditions
Interventions
Duration: Eight weeks Test food: The test food containing plant extract (PE) Administration: Take one packet once a day after breakfast *If you forget to take the test food at the breakfast, take
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women aged 20 or more 3. Healthy subjects 4. Subjects who have subjective tinnitus 5. Subjects whose the score of THI-J are between 18 and 56
Exclusion criteria
Exclusion criteria: Subjects 1. who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. who are undergoing medical treatment or have a medical history for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use 5. who currently taking medications (including herbal medicines) and supplements 6. who are allergic to medicines and/or the test food related products 7. who are pregnant, lactation, or planning to become pregnant during this trial 8. who suffer from COVID-19 9. who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 10. who have medical treatment, prescription, or lifestyle counseling by a doctor due to tinnitus 11. who have medical treatment or prescription by a doctor due to ear disease (such as sudden hearing loss, acoustic neuroma, Meniere's disease, otitis media, otosclerosis, or otitis externa), or who have a medical history of severe ear disease 12. who have undergone otological surgery (such as cochlear implantation, meatoplasty, tympanoplasty, or stapes surgery) 13. who use devices to assist hearing such as hearing aid 14. who have medical treatment or prescription by a doctor due to psychiatric disorder (such as depressive disorder, bipolar disorder, schizophrenia, panic disorder, or obsessive-compulsive disorder) 15. whose sleeping time or habit is irregular due to working a late-night shift 16. who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Total score of the Tinnitus Handicap Inventory-J (THI-J) at eight weeks after consumption (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total score of the Tinnitus Handicap Inventory-J (THI-J) at four weeks after consumption (4w) 2. Each items of THI-J at 4w and 8w 3. The medical questionnaire items of the standardized tinnitus test 1993 at 4w and 8w 4. Total score and each score of The Japanese version of the Pittsburgh Sleep Quality Index (PSQI-J) at 4w and 8w 5. Total score and each score of Profile of Mood States 2nd Edition (POMS2) at 4w and 8w 6. Subjective symptoms measured by visual analogue scale (VAS) at 4w and 8w 7. Diacron-reactive oxygen metabolites (d-ROM) and biological anti-oxidant potential (BAP) in the blood and 8-hydroxy-2'-deoxyguanosine (8-OHdG) in the urine at 4w and 8w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed