Adult
Conditions
Interventions
Enzymolyzed Honeybee Larvae product 1 Ingestion 720 mg per day Period 4 week
Enzymolyzed Honeybee Larvae product 2 Ingestion 360 mg per day Period 4 week
Enzymolyzed Honeybee Larvae product 3 Ing
Sponsors
Yamada Bee Company, Inc.
Research Center for Immunological Analysis. Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Target subjects must satisfy the following selection criteria. 1. Healthy Japanese with tinnitus aged between 40 and 75 years old 2. Not received medical treatment, therapy or treatment, regardless of seasonality, chronic or sudden diseases 3. with written consent spontaneously 4. Can prohabit excessive exercise 5. Can prohabit drinking and eating too much 6. Can prevent conception 7. Can understand and comply with the rules written in protocol 8. Judged appropriate for participation in this study by the doctor.
Exclusion criteria
Exclusion criteria: The subjects in conflict with any of the following condition are excluded. 1. Have ingested bee larvea-containing food in 2018 2. No consciousness of tinnitus 3. With a THI score =0 or >=38 4. Under treatment for tinnitus 5. Have a disorder affecting the examination, such as otolaryngology system, internal medicine system (diabetes, cardiovascular disease) 6. With food allergies 7. Ingest medicines or health foods that may affect test results 8. Have restriction of niacin from doctor 9. Pregnant or breast-feeding women, or applicant of pregnancy 10. With a disease in the gastrointestinal tract, liver, kidney, heart and cardiovascular affecting absorption, distribution, metabolism, excretion of the test food 11. Have a history of cerebrovascular disorder, cranial nerve disease, etc. 12. Underwent blood sampling (=<200 mL within 4 weeks, or =<400 mL within 3 months) before the start of this study. 13. Be Suspected alcohol or drug dependence 14. Had participated over the past 3 months, or currently participate in other clinical trials 15. Have a irregular habit 16. Have a housemate participating or scheduling to participate this clinical study. 17. Cannot comply with the rules written in protocol 18. Judged inappropriate for participation in this study by the doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Visual Analog Scale(VAS) score (laudness, time, annoyance and total score of them). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Tinnitus Handicap Inventory(THI) 2. VAS score (hearing, dizziness, fatigue, awakening and asleep). 3. Adverse events, physiological examination, hematological examination, blood biochemical examination, and urinalysis before intake and 4week. | — |
Countries
Japan
Contacts
Public ContactHideyo Nagae
Yamada Bee Company, Inc. Institute for Bee Products & Health Science
Outcome results
None listed