UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028327 |
|---|---|
| Receipt number | R000032418 |
| Scientific Title | Evaluation of the effects of protease-digested lyophilized powder of bee larvae on dizziness. |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2021/03/11 10:36:26 |
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Basic information
Public title
Evaluation of the effects of protease-digested lyophilized powder of bee larvae on dizziness.
Acronym
Evaluation of the effects of protease-digested lyophilized powder of bee larvae on dizziness.
Scientific Title
Evaluation of the effects of protease-digested lyophilized powder of bee larvae on dizziness.
Scientific Title:Acronym
Evaluation of the effects of protease-digested lyophilized powder of bee larvae on dizziness.
Region
| Japan |
Condition
Condition
Patient with dizziness
Classification by specialty
| Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of present study is to evaluate the effects of protease-digested lyophilized powder of bee larvae on dizziness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dizziness Handicap Inventory (DHI)
(at a few weeks and 1 day before the intervention, and after 4, 8, 12, 16 weeks of daily intake.)
Key secondary outcomes
Frenzel eye movement measurement, stabilometry, the measurement with autonomic nervous system
(at 1 day before the intervention, and after 4, 8, 12, 16 weeks of daily intake.)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral administration of protease-digested lyophilized powder of bee larvae (720 mg/day, 12weeks)
Interventions/Control_2
Oral administration of placebo (everyday, 12weeks)
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
[1] Subjects with dizziness who have not improved the symptoms with at least 4 weeks drug treatment.
Key exclusion criteria
[1] Individuals with acute vertigo (meniere's syndrome, benign paroxysmal positional vertigo, vestibular neuritis and so on)
[2] Individuals with dizziness and vertigo caused by severe desease (cerebral infarction, intracranial hemorrhage, brain tumor and so on).
[3] Individuals who have a severe allergy or asthma.
[4] Heavy smoker or alcoholism.
[5] Individuals whose dietary habit is excessively irregular.
[6] Individuals who usually take bee larvae.
[7] Individuals who have an infection needed systemic therapy.
[8] Individuals who are considered that participation for this trial is difficult because of psychiatric symptoms or psychosis.
[9] Individuals who have a kidney disease.
[10] Individuals judged inappropriate for participating the study by the principal
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Sakata |
Organization
Kawagoe Otology Institute
Division name
Department of Otolaryngology
Zip code
350-1122
Address
Kawagoe mainmedical center kawagoe second floor 103, Wakitamachi, Kawagoe-shi, Saitama, Japan
TEL
049-226-3387
sakata@jikagaku.jp
Public contact
Name of contact person
| 1st name | Emi |
| Middle name | |
| Last name | Ogawa |
Organization
Kawagoe Otology Institute
Division name
Department of Otolaryngology
Zip code
350-1122
Address
Kawagoe mainmedical center kawagoe second floor 103, Wakitamachi, Kawagoe-shi, Saitama, Japan
TEL
049-226-3387
Homepage URL
sakata@jikagaku.jp
Sponsor or person
Institute
Kawagoe Otology Institute
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Research Center for Immunological Analysis. Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic
Address
6F DaiwaA Hamamatsucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
03-5408-1590
jimukyoku@mail.souken-r.com
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
| 2019 | Year | 03 | 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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 21 | Day |
Last modified on
| 2021 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032418
