UMIN-CTR Clinical Trial

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