UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034706
Receipt number R000039572
Scientific Title Clinical trial of the effect of honeybee larvae production on the hearing ability
Date of disclosure of the study information 2018/12/01
Last modified on 2020/11/02 17:40:40

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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 or person

Institute

Gifu Univesity School of Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039572


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name