UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020950
Receipt No. R000024170
Scientific Title A Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Usefulness of Oligonol for Hearing Discomfort
Date of disclosure of the study information 2016/02/09
Last modified on 2017/02/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Usefulness of Oligonol for Hearing Discomfort
Acronym Evaluation of Usefulness of Oligonol for Hearing Discomfort
Scientific Title A Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Usefulness of Oligonol for Hearing Discomfort
Scientific Title:Acronym Evaluation of Usefulness of Oligonol for Hearing Discomfort
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the usefulness of daily ingestion of Oligonol for 4 weeks for tinnitus and additionally examine the improvement of blood flow.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Tinnitus Handicap Inventory (THI)
Key secondary outcomes Visual Analog Scale (VAS) score for subjective symptoms, temperature of tympanum, peripheral blood flow and blood pressure at visit

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 NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Ingestion of capsules containing Oligonol daily for 4 weeks.
Interventions/Control_2 Ingestion of placebo capsules daily for 4 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
20 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1. Subjects with slight tinnitus.
2. Subjects with relatively high THI scores (selected via screening).
3. Subjects who agree to participate in this study with a written informed consent.
Key exclusion criteria 1. Subjects who are under physician's advice, treatment and/or medication for tinnitus.
2. Subjects who are under physician's treatment and/or medication for ear disorders such as Sudden Sensorineural Hearing Loss (SSHL), acoustic neuroma, Meniere's disease, otitis media, otosclerosis, otitis externa, etc. or who have a history of severe ear disorder(s).
3. Subjects who have been operated upon cochlear implant, meatoplasty, tympanoplasty, stapes surgery, etc.
4. Subjects who wear hearing-support device(s).
5. Subject whose THI scores are >=58
6. Subjects who are under treatment and medication for psychiatric disorders.
7. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, disorder of endocrine and metabolism or affected with infectious diseases which are required to report to the authorities.
8. Subjects who have a history of gastrectomy, gastrorrhaphy, enterectomy and/ or other serious gastrointestinal surgeries.
9. Subjects with unusually high and/or low blood pressure, or with abnormal hematological data.
10. Subjects who have a severe anemia.
11. Pre- or post-menopausal women having obvious changes in physical condition.
12. Subjects who have a history of allergy or sensitivity to medicine and / or food (especially lychees, tea, gelatin and pork).
13. Subjects who regularly take drugs, functional foods and/or supplements which may relieve tinnitus.
14. Heavy smokers, alcohol addicts or subjects with irregular lifestyle.
15. Subjects who donate either 400 ml whole blood within 12 weeks or 200 ml whole blood within 4 weeks or blood components within 2 weeks prior to this study.
16. Pregnant or lactating women or women expect to be pregnant during the study.
17. Subjects who participate in other clinical trials within the last one month prior to this study.
18. Any other medical reasons judged by the doctor-in-charge.
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Department of Medical Management and Informatics
Zip code
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4411
Email nishihira@do-johodai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Health Information Science Center
Zip code
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4430
Homepage URL
Email nishihira@do-johodai.ac.jp

Sponsor
Institute Hokkaido Information University
Institute
Department

Funding Source
Organization Amino Up Chemical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 北海道情報大学 保健センター(北海道)

Other administrative information
Date of disclosure of the study information
2016 Year 02 Month 09 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 Main results already published
Date of protocol fixation
2015 Year 12 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 10 Day
Last follow-up date
2016 Year 04 Month 03 Day
Date of closure to data entry
2016 Year 04 Month 07 Day
Date trial data considered complete
2016 Year 04 Month 14 Day
Date analysis concluded
2018 Year 07 Month 26 Day

Other
Other related information

Management information
Registered date
2016 Year 02 Month 09 Day
Last modified on
2017 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024170

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.