UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028327
Receipt No. 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 2019/03/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email sakata@jikagaku.jp

Sponsor
Institute Kawagoe Otology Institute
Institute
Department

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
Email 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 No longer recruiting
Date of protocol fixation
2017 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 31 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
2017 Year 07 Month 21 Day
Last modified on
2019 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032418

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.