UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026169 |
|---|---|
| Receipt number | R000030066 |
| Scientific Title | An influence of a "tablet containing Haskap" on a symptomatic relief for a healthy person who is aware of eyestrain |
| Date of disclosure of the study information | 2017/04/30 |
| Last modified on | 2018/04/10 16:52:56 |
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Basic information
Public title
An influence of a "tablet containing Haskap" on a symptomatic relief for a healthy person who is aware of eyestrain
Acronym
An influence of a "tablet containing Haskap" on a symptomatic relief for a healthy person who is aware of eyestrain
Scientific Title
An influence of a "tablet containing Haskap" on a symptomatic relief for a healthy person who is aware of eyestrain
Scientific Title:Acronym
An influence of a "tablet containing Haskap" on a symptomatic relief for a healthy person who is aware of eyestrain
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine an influence of a test food product on eye symptoms (eyestrain and the like). Males and females of Japanese nationality who are aware of eyestrain on a daily basis will be assigned to take the test food product for 4 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Near point (Accommodation ability test)
Key secondary outcomes
1. Equivalent spherical surface degree (Refractive power test)
2. Survey on subjective symptoms
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
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
4-week intake of the test food
Interventions/Control_2
4-week intake of the placebo food
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Age: 20 and over, below 40
2) Males and females with Japanese nationality
3) Persons who are aware of eyestrain on a daily basis
4) Persons who routinely plays videogames, uses a PC and/or a smartphone, or works on a VDT for at least 4 hours a day.
5) BMI under 30.0
6) Visual acuities of both eyes are 0.7 or higher (with or without vision correction devices)
7) Of those who are fully informed of the objective and contents of this study, have an ability to consent, and voluntarily wish to participate in this study with a clear understanding, persons who agree to participate in this study in writing.
Key exclusion criteria
1) Currently in treatment with medication
2) Currently in dietary therapy and/or exercise therapy under medical supervision
3) Presence or previous history of a hepatic disorder, a severe kidney, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disorder, or a complication of these.
4) Those who are astigmatic
5) Those who uses a medical product, health food product, or a supplement claiming a positive effect on eyestrain or dry eye
6) Those who have an organic disease such as cataract, glaucoma, or strabismus
7) Presence or previous history of a mental disorder (depression, etc.)
8) Previous history of drug allergy or food allergy
9) Currently in treatment or previous history of drug addiction or drug abuse
10) Pregnant or nursing, or desired to become pregnant during the study
11) Participation in any other clinical study within 1 month or current participation in any other clinical study
12) Irregular work hours, such as night shifts
13) Difficulty in compliance with recording of various surveys
14) Determined by the investigator to be unsuitable for enrollment in this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hira Yoshitada |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
Address
Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
81-3-3431-1260
hira@huma-c.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hira Yoshitada |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
Address
Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
81-3-3431-1260
Homepage URL
hira@huma-c.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
Northern Advancement Center for Science & Technology
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 04 | Month | 30 | 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
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 13 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 14 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 16 | Day |
Last modified on
| 2018 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030066
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| Registered date | File name |
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| Registered date | File name |
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