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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031207
Receipt No. R000035185
Scientific Title Effect of Enzymolyzed Honeybee Larvae on tinnitus-related symptoms.
Date of disclosure of the study information 2019/02/20
Last modified on 2018/06/04

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Basic information
Public title Effect of Enzymolyzed Honeybee Larvae on tinnitus-related symptoms.
Acronym Effect of Enzymolyzed Honeybee Larvae on tinnitus-related symptoms.
Scientific Title Effect of Enzymolyzed Honeybee Larvae on tinnitus-related symptoms.
Scientific Title:Acronym Effect of Enzymolyzed Honeybee Larvae on tinnitus-related symptoms.
Region
Japan

Condition
Condition Adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of Enzymolyzed Honeybee Larvae on mild tinnitus-related symptoms.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Visual Analog Scale(VAS) score
(laudness, time, annoyance and total score of them).
Key secondary outcomes 1. Tinnitus Handicap Inventory(THI)
2. VAS score (hearing, dizziness, fatigue, awakening and asleep).
3. Adverse events, physiological examination, hematological examination, blood biochemical examination, and urinalysis
before intake and 4week.

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 4
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Enzymolyzed Honeybee Larvae product 1
Ingestion 720 mg per day
Period 4 week
Interventions/Control_2 Enzymolyzed Honeybee Larvae product 2
Ingestion 360 mg per day
Period 4 week
Interventions/Control_3 Enzymolyzed Honeybee Larvae product 3
Ingestion 180 mg per day
Period 4 week
Interventions/Control_4 Placebo product
Period 4 week
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria Target subjects must satisfy the following selection criteria.
1. Healthy Japanese with tinnitus aged between 40 and 75 years old
2. Not received medical treatment, therapy or treatment, regardless of seasonality, chronic or sudden diseases
3. with written consent spontaneously
4. Can prohabit excessive exercise
5. Can prohabit drinking and eating too much
6. Can prevent conception
7. Can understand and comply with the rules written in protocol
8. Judged appropriate for participation in this study by the doctor.
Key exclusion criteria The subjects in conflict with any of the following condition are excluded.
1. Have ingested bee larvea-containing food in 2018
2. No consciousness of tinnitus
3. With a THI score =0 or >=38
4. Under treatment for tinnitus
5. Have a disorder affecting the examination, such as otolaryngology system, internal medicine system (diabetes, cardiovascular disease)
6. With food allergies
7. Ingest medicines or health foods that may affect test results
8. Have restriction of niacin from doctor
9. Pregnant or breast-feeding women, or applicant of pregnancy
10. With a disease in the gastrointestinal tract, liver, kidney, heart and cardiovascular affecting absorption, distribution, metabolism, excretion of the test food
11. Have a history of cerebrovascular disorder, cranial nerve disease, etc.
12. Underwent blood sampling (=<200 mL within 4 weeks, or =<400 mL within 3 months) before the start of this study.
13. Be Suspected alcohol or drug dependence
14. Had participated over the past 3 months, or currently participate in other clinical trials
15. Have a irregular habit
16. Have a housemate participating or scheduling to participate this clinical study.
17. Cannot comply with the rules written in protocol
18. Judged inappropriate for participation in this study by the doctor.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuyuki Nomura
Organization Medical corporation Koganeibasi Sakura Clinic
Division name Not applicable
Zip code
Address 2-11-25 Sakuramachi, Koganei-city, Tokyo, 184-0005, Japan
TEL 042-382-5252
Email info@kb-clinic.com

Public contact
Name of contact person
1st name
Middle name
Last name Hideyo Nagae
Organization Yamada Bee Company, Inc.
Division name Institute for Bee Products & Health Science
Zip code
Address 194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL 0868-54-1199
Homepage URL
Email hn1726@yamada-bee.com

Sponsor
Institute Yamada Bee Company, Inc.
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) none

IRB Contact (For public release)
Organization
Address
Tel
Email

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 02 Month 20 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
2018 Year 02 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 23 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
2018 Year 02 Month 08 Day
Last modified on
2018 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035185

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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