UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048608 |
|---|---|
| Receipt number | R000055334 |
| Scientific Title | Effects of consumption of the test food on subjective tinnitus in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2022/08/10 |
| Last modified on | 2023/03/29 13:04:29 |
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Basic information
Public title
Effects of consumption of the test food on subjective tinnitus in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Acronym
Effects of consumption of the test food on subjective tinnitus in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title
Effects of consumption of the test food on subjective tinnitus in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of consumption of the test food on subjective tinnitus in healthy Japanese subjects
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on subjective tinnitus in healthy Japanese subjects
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Total score of the Tinnitus Handicap Inventory-J (THI-J) at eight weeks after consumption (8w)
Key secondary outcomes
1. Total score of the Tinnitus Handicap Inventory-J (THI-J) at four weeks after consumption (4w)
2. Each items of THI-J at 4w and 8w
3. The medical questionnaire items of the standardized tinnitus test 1993 at 4w and 8w
4. Total score and each score of The Japanese version of the Pittsburgh Sleep Quality Index (PSQI-J) at 4w and 8w
5. Total score and each score of Profile of Mood States 2nd Edition (POMS2) at 4w and 8w
6. Subjective symptoms measured by visual analogue scale (VAS) at 4w and 8w
7. Diacron-reactive oxygen metabolites (d-ROM) and biological anti-oxidant potential (BAP) in the blood and 8-hydroxy-2'-deoxyguanosine (8-OHdG) in the urine at 4w and 8w
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: Eight weeks
Test food: The test food containing plant extract (PE)
Administration: Take one packet once a day after breakfast
*If you forget to take the test food at the breakfast, take it as soon as you remember within the day and record a taking time with the diary report. Daily dose should be taken within the day and not carried over to the next day.
Interventions/Control_2
Duration: Eight weeks
Test food: Placebo food
Administration: Take one packet once a day after breakfast
*If you forget to take the test food at the breakfast, take it as soon as you remember within the day and record a taking time with the diary report. Daily dose should be taken within the day and not carried over to the next day.
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. Japanese
2. Men or women aged 20 or more
3. Healthy subjects
4. Subjects who have subjective tinnitus
5. Subjects whose the score of THI-J are between 18 and 56
Key exclusion criteria
Subjects
1. who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. who are undergoing medical treatment or have a medical history for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use
5. who currently taking medications (including herbal medicines) and supplements
6. who are allergic to medicines and/or the test food related products
7. who are pregnant, lactation, or planning to become pregnant during this trial
8. who suffer from COVID-19
9. who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
10. who have medical treatment, prescription, or lifestyle counseling by a doctor due to tinnitus
11. who have medical treatment or prescription by a doctor due to ear disease (such as sudden hearing loss, acoustic neuroma, Meniere's disease, otitis media, otosclerosis, or otitis externa), or who have a medical history of severe ear disease
12. who have undergone otological surgery (such as cochlear implantation, meatoplasty, tympanoplasty, or stapes surgery)
13. who use devices to assist hearing such as hearing aid
14. who have medical treatment or prescription by a doctor due to psychiatric disorder (such as depressive disorder, bipolar disorder, schizophrenia, panic disorder, or obsessive-compulsive disorder)
15. whose sleeping time or habit is irregular due to working a late-night shift
16. who are judged as ineligible to participate in the study by the physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel
03-5793-3623
IRB@takara-clinic.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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 10 | 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
66
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
| 2022 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2022 | Year | 08 | Month | 05 | Day |
Last modified on
| 2023 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055334
