UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Enzymolyzed Honeybee Larvae on tinnitus-related symptoms.
Acronym	Effect of Enzymolyzed Honeybee Larvae on tinnitus-related symptoms.
Scientific Title	Effect of Enzymolyzed Honeybee Larvae on tinnitus-related symptoms.
Scientific Title:Acronym	Effect of Enzymolyzed Honeybee Larvae on tinnitus-related symptoms.
Region	Japan

Condition
Condition	Adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of Enzymolyzed Honeybee Larvae on mild tinnitus-related symptoms.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Visual Analog Scale(VAS) score (laudness, time, annoyance and total score of them).
Key secondary outcomes	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.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Enzymolyzed Honeybee Larvae product 1 Ingestion 720 mg per day Period 4 week
Interventions/Control_2	Enzymolyzed Honeybee Larvae product 2 Ingestion 360 mg per day Period 4 week
Interventions/Control_3	Enzymolyzed Honeybee Larvae product 3 Ingestion 180 mg per day Period 4 week
Interventions/Control_4	Placebo product Period 4 week
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key 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.
Key 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.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuyuki Nomura
Organization	Medical corporation Koganeibasi Sakura Clinic
Division name	Not applicable
Zip code
Address	2-11-25 Sakuramachi, Koganei-city, Tokyo, 184-0005, Japan
TEL	042-382-5252
Email	info@kb-clinic.com

Public contact
Name of contact person	1st name Middle name Last name Hideyo Nagae
Organization	Yamada Bee Company, Inc.
Division name	Institute for Bee Products & Health Science
Zip code
Address	194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL	0868-54-1199
Homepage URL
Email	hn1726@yamada-bee.com

Sponsor
Institute	Yamada Bee Company, Inc.
Institute
Department

Funding Source
Organization	Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Research Center for Immunological Analysis. Inc.
Name of secondary funder(s)	none

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 06 Day
Date of IRB	2018 Year 02 Month 19 Day
Anticipated trial start date	2018 Year 02 Month 23 Day
Last follow-up date	2018 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 02 Month 08 Day
Last modified on	2022 Year 05 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035185