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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045724
Receipt No. 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 2021/10/12

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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
Email 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
Email info@yakujihou.org

Sponsor
Institute Japan Clinical Trial Association
Institute
Department

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
Email 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
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
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
2021 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052199

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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