UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trial of the effect of honeybee larvae production on the hearing ability
Acronym	Honeybee larvae study
Scientific Title	Clinical trial of the effect of honeybee larvae production on the hearing ability
Scientific Title:Acronym	Honeybee larvae study
Region	Japan

Condition
Condition	sensorineural hearing loss
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of honeybee larave on the subjective perception of hearing ability
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of the hearing level on audiometry
Key secondary outcomes	Hearing Handicap Inventory for elderly,,Geriatric depression score,Chalder fatigue scale,, speech discrimination under noise, blood findings(IL2R, IL6,IL12,HDLC,LDLC,oxidative LDL,NO,DHEAS,HbA1c,adiponectine,SIRT1/3,Cre,UA,eGF,S1P)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intervention period (12 weeks), mount of intervention food (honeybee larvae 180mg x 4 tablets/day
Interventions/Control_2	Intervention period (12 weeks), placebo 4 tablets/day
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	60 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1. no perforation of the drum 2. mild bilateral sensorineural hearing loss (26-40dB) or moderate bilateral sensorineural hearing loss (41-60 dB) 3. subjective tinnitus of unilateral or bilateral ear 4. well understand the objective of this study
Key exclusion criteria	1. subjects who already have had honeybee larave 2. active ottis media 3. acute hearing loss 4. apparent inner ear disease such as Meniere's disease 5. subjects who have received the treatment for hearing loss 6. allergy of the food 7. digestive dysfucntion of the honeybee larave products 8. cerebral vascular disease 9. blood donor within these 4 weeks 10. alcohol or drug dependence syndrome 11. subjects who had attended another clinical trial within 3 months 12. subjects living with teh house mate who attend this study 13. subjects who do not comply the rulr of this study 14. subject who are pointed out as nscreened personnel
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Mitsuhiro Middle name Last name Aoki
Organization	Gifu university School of medicine
Division name	Department of Otolaryngology
Zip code	5011194
Address	1-1 Yanagido, Gifu city
TEL	0582306279
Email	aoki@gifu-u.ac.jp

Public contact
Name of contact person	1st name Mitsuhiro Middle name Last name Aoki
Organization	GIfu university Hospital
Division name	Department of Otolaryngology
Zip code	5011194
Address	1-1 Yanagido, Gifu city
TEL	0582306279
Homepage URL
Email	aoki@gifu-u.ac.jp

Sponsor
Institute	Gifu Univesity School of Medicine
Institute
Department

Funding Source
Organization	Yamada Bee company
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Innovative and Clinical Research Promotion Center
Address	1-1 Yanagido
Tel	0582307292
Email	m_matsu@gifu-u.ac.jp

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	2018 Year 12 Month 01 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	Open public recruiting
Date of protocol fixation	2018 Year 08 Month 01 Day
Date of IRB	2018 Year 08 Month 01 Day
Anticipated trial start date	2018 Year 12 Month 01 Day
Last follow-up date	2021 Year 08 Month 31 Day
Date of closure to data entry	2022 Year 01 Month 31 Day
Date trial data considered complete	2022 Year 01 Month 31 Day
Date analysis concluded	2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 10 Month 30 Day
Last modified on	2020 Year 11 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039572