UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062719 |
|---|---|
| Receipt number | R000071780 |
| Scientific Title | A Study on the Efficacy of test food in Volunteers with Tinnitus-Like Symptoms |
| Date of disclosure of the study information | 2026/09/04 |
| Last modified on | 2026/08/28 09:39:13 |
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Basic information
Public title
A Study on the Efficacy of test food in Volunteers with Tinnitus-Like Symptoms
Acronym
A Study on the Efficacy of test food in Volunteers with Tinnitus-Like Symptoms
Scientific Title
A Study on the Efficacy of test food in Volunteers with Tinnitus-Like Symptoms
Scientific Title:Acronym
A Study on the Efficacy of test food in Volunteers with Tinnitus-Like Symptoms
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of continuous consumption of the test food for 12 weeks on tinnitus-like symptoms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
THI(Tinnitus Handicap Inventory)
TFI(Tinnitus Functional Index)
VAS(Visual Analogue Scale)
PTA(Pure Tone Audiometry)
Pitch Match test
Loudness Balance test
Key secondary outcomes
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingest the test food for 12 weeks
Interventions/Control_2
Ingest the placebo food for 12 weeks
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Subjects recognized as healthy by a doctor's diagnosis
2) Japanese males and females aged 18 to 75 years-old at the time of informed consent
3) Subjects who experience tinnitus and have a THI (Tinnitus Handicap Inventory) score of 18 to 56
4) Subjects who have received a thorough explanation of the protocol, have understood its content, and have provided written consent to participate in this trial
Key exclusion criteria
1) Subjects who have a history of severe ear disorders such as Sudden Sensorineural Hearing Loss (SSHL), acoustic neuroma, Meniere's disease, etc.
2) Subjects who wear hearing aids .
3) Subjects with mental disorders (depressive disorders, bipolar disorder, schizophrenia, panic disorder, obsessive-compulsive disorder, etc.)
4) Subject who are unable to stop consuming foods and beverages with specific health claims, foods with functional claims, or other foods and beverages believed to have functional properties during the study period.
5) Subjects receiving treatment, medication, and lifestyle guidance from a doctor due to tinnitus or ear disease
6) Subject who has serious disorders on brain, hepatic, kidney, cardiac, lung, digestive organs, blood, endocrine system, and metabolic system
7) Subjects who have diseases requiring continuous medication, or serious medical history who needed medication
8) Subjects who have a history of a serious disease that required medication
9) Subjects currently receiving medical treatment for a gastrointestinal disorder, or those with a history of gastrointestinal surgery (excluding appendectomy performed more than 30 days prior to obtaining consent)
10) Subjects with history of sensitivity to the ingredients of test food
11) Pregnant, lactating women or willing to be pregnancy during the clinical trial
12) Subjects who are judged to be unsuitable based on their responses to the background survey
13) Subject who took part in the other clinical/monitoring trial within 30 days before giving informed consent to take part in this trial.
14) Subjects who have been deemed unsuitable as clinical trial participants by the principal investigator or sub-investigator
Target sample size
184
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Nagashima |
Organization
TOKYO CENTER CLINIC
Division name
Director
Zip code
103-0027
Address
2-9-10, Nihonbashi, Chuo-ku, Tokyo, Japan
TEL
03-3276-6935
takahashi-hozumi@tc-clinic.jp
Public contact
Name of contact person
| 1st name | Shigeru |
| Middle name | |
| Last name | Imai |
Organization
Leverage Brain Inc.
Division name
Clinical Trial Department
Zip code
150-0002
Address
1-4-7, Shibuya, Shibuya-ku, Tokyo, Japan
TEL
080-7290-0404
Homepage URL
imai@levbrain.com
Sponsor or person
Institute
Leverage Brain Inc.
Institute
Department
Personal name
Shigeru Imai
Funding Source
Organization
Senju Pharmaceutical co.,ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
1-9-10, Hamamatsucho, Minato-ku, Tokyo, Japan
Tel
03-5404-1599
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
東京センタークリニック（東京都）/TOKYO CENTER CLINIC (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2026 | Year | 08 | Month | 28 | Day |
Last modified on
| 2026 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071780
