UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045724 |
|---|---|
| Receipt number | R000052199 |
| Scientific Title | Examination of the effectiveness of low-molecular-weight lychee polyphenol-containing foods for tinnitus and ear discomfort in healthy subjects: a randomized, double blind, placebo-controlled study |
| Date of disclosure of the study information | 2021/10/14 |
| Last modified on | 2023/10/05 12:12:10 |
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Basic information
Public title
Examination of the effectiveness of low-molecular-weight lychee polyphenol-containing foods for tinnitus and ear discomfort in healthy subjects
Acronym
SC tinnitus study
Scientific Title
Examination of the effectiveness of low-molecular-weight lychee polyphenol-containing foods for tinnitus and ear discomfort in healthy subjects: a randomized, double blind, placebo-controlled study
Scientific Title:Acronym
Examination of the effectiveness of low-molecular-weight lychee polyphenol-containing foods for tinnitus and ear discomfort in healthy subjects
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect of reducing tinnitus and ear discomfort by continuously ingesting the test article for 8 weeks, and to clarify its effectiveness.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
THI questionnaire, Pitch Match Test, Audiometry
Key secondary outcomes
Subjective assessment, VAS, Blood test
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
Take the test article for 8 weeks
Interventions/Control_2
Take the placebo for 8 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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects who realize mild tinnitus
2. Subjects with high THI scores
3. Subjects recognized as healthy by a doctor's diagnosis
Key exclusion criteria
1. Subjects receiving treatment, medication, and lifestyle guidance from a doctor due to tinnitus or ear disease
2. Subjects who underwent ear surgery
3. Subjects using hearing aids and other hearing aids
4. Pregnant women, lactating women, and those who are planning to become pregnant during the test period
5. Subjects who are judged as unsuitable for the study by the investigator for the other reason
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Masatomo |
| Middle name | |
| Last name | Najima |
Organization
Japan Clinical Trial Association
Division name
N.A.
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
info@yakujihou.org
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kaneko |
Organization
Japan Clinical Trial Association
Division name
N.A.
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
Homepage URL
info@yakujihou.org
Sponsor or person
Institute
Japan Clinical Trial Association
Institute
Department
Personal name
Funding Source
Organization
Sain Clarte 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
Institutional Review Board of Pharmaceutical Law Wisdoms
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel
0364574911
master@yakujihou.net
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
| 2021 | Year | 10 | Month | 14 | Day |
Related information
URL releasing protocol
https://www.shinryo-to-shinyaku.com/db/pdf/sin_0060_03_0153.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.shinryo-to-shinyaku.com/db/pdf/sin_0060_03_0153.pdf
Number of participants that the trial has enrolled
33
Results
In the test product group, significant decreases in hearing thresholds were observed in THI (8 w), PTA left (8 w), and PTA left and right average value (8 w). In addition, his VAS (8W), which is a subjective evaluation, showed a tendency to improve psychologically, and the results of each measurement and the doctor's overall evaluation from the examination showed that both 4W and 8W were better than the placebo group. Significant improvement in ear discomfort was observed.
Results date posted
| 2023 | Year | 10 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Active: 51.1 years old, THI 19.2
Placebo: 51.0 years old, THI 13.6
Participant flow
The trial started with 49 people. Of the 49 patients he started, one dropped out and 48 completed the study (23 in the test product group and 25 in the placebo group). Of those who completed the study, 33 people were analyzed, excluding those who did not complete the study as planned due to physician judgment (6 people in the test product group, 9 people in the placebo group).
Adverse events
none
Outcome measures
THI, PTA, VAS
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 12 | Day |
Last modified on
| 2023 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052199
