UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003022 |
|---|---|
| Receipt number | R000003510 |
| Scientific Title | Clinical evidence for therapeutic effects of bee larvae on Meniere's disease |
| Date of disclosure of the study information | 2010/01/15 |
| Last modified on | 2013/01/13 09:09:43 |
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Basic information
Public title
Clinical evidence for therapeutic effects of bee larvae on Meniere's disease
Acronym
Therapeutic effects of bee larvae on Meniere's disease
Scientific Title
Clinical evidence for therapeutic effects of bee larvae on Meniere's disease
Scientific Title:Acronym
Therapeutic effects of bee larvae on Meniere's disease
Region
| Japan |
Condition
Condition
meniere's disease
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical efficience of bee larvae for Meniere's disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tinnitus handicap score, pure tone audiogram, otodynamic emission, dizziness handicap score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
bee larvae 720mg per day fro 12 weeks
Interventions/Control_2
dexystrin 720mg per day for 12 weeks
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patiensts with agreement for this study
Key exclusion criteria
except for patients with malignant disease
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mistuhiro Aoki |
Organization
Gifu University
Division name
Department of Otolaryngology
Zip code
Address
1-1 Yanagido Gifu city
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Gifu University
Division name
Department of Otolaryngology
Zip code
Address
TEL
Homepage URL
aoki@gifu-u.ac.jp
Sponsor or person
Institute
Deaprtment of Otolaryngology, Gifu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Farm Grant for Honeybee Research
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
Address
Tel
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
| 2010 | Year | 01 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2009 | Year | 11 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 13 | Day |
Last modified on
| 2013 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003510
