Effects of consumption of the test food on subjective tinnitus in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000048608
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 66
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Total score of the Tinnitus Handicap Inventory-J (THI-J) at eight weeks after consumption (8w)
- Secondary Outcome Measures
Name Time Method 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