UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031207 |
|---|---|
| Receipt number | 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 | 2022/05/19 09:24:52 |
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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
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
hn1726@yamada-bee.com
Sponsor or person
Institute
Yamada Bee Company, Inc.
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)
none
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
| 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
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 23 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 31 | Day |
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
| 2022 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035185
| Research Plan | |
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| Research case data specifications | |
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