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
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
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
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
