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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034706
Receipt No. R000039572
Official scientific title of the study 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 2018/10/30

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Basic information
Official scientific title of the study Clinical trial of the effect of honeybee larvae production on the hearing ability
Title of the study (Brief title) 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 Mitsuhiro Aoki
Organization Gifu university School of medicine
Division name Department of Otolaryngology
Address 1-1 Yanagido, Gifu city
TEL 0582306279
Email aoki@gifu-u.ac.jp

Public contact
Name of contact person Mitsuhiro Aoki
Organization GIfu university Hospital
Division name Department of Otolaryngology
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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 08 Month 01 Day
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

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


Link to view the page
URL(English) https://upload.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


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