UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Usefulness of Oligonol for Hearing Discomfort
Title of the study (Brief title)	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	Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization	Hokkaido Information University
Division name	Department of Medical Management and Informatics
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	Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization	Hokkaido Information University
Division name	Health Information Science Center
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 12 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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