UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034224 |
|---|---|
| Receipt number | R000039014 |
| Scientific Title | A study evaluating the effect of botanical ingredient-containing food on eye strain. |
| Date of disclosure of the study information | 2018/10/30 |
| Last modified on | 2018/09/20 20:25:16 |
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Basic information
Public title
A study evaluating the effect of botanical ingredient-containing food on eye strain.
Acronym
A study evaluating the efficacy of botanical ingredient-containing food on eye strain.
Scientific Title
A study evaluating the effect of botanical ingredient-containing food on eye strain.
Scientific Title:Acronym
A study evaluating the efficacy of botanical ingredient-containing food on eye strain.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of the botanical ingredient-containing food on eye strain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
High Frequency Component 1
Key secondary outcomes
Visual Analogue Scale questionnaire
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Botanical ingredient-containing food
Interventions/Control_2
Botanical ingredient-not containing 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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Individuals aged from 20 to 65 years, when giving the informed consent.
(2)Individuals who are aware of eye strain.
(3)Individuals giving the written informed consent.
Key exclusion criteria
(1)Individuals who use medication or supplements or functional foods affecting eye strain.
(2)Individuals who is not suitable for subjects by pre-test questionnaire.
(3)Individuals who declare the allergy symptoms against test diets.
(4)Individuals who have a chronic disease and use medicines continuously, or have a history of chronic disease.
(5)Individuals who have a history of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder, or have a history of these disease.
(6)Individuals who have a history of digestive disease affecting digestion and absorption.
(7)Individuals who have ophthalmologic disease, or have a history of ophthalmologic disease.
(8)Individuals who is not suitable for subjects by pre-test.
(9)Individuals who are planned to participate in other clinical study.
(10)Individuals who have donated over 200 mL of blood and/or blood component within the last one month prior to the current study or over 400 mL of blood and/or blood component within the last three months prior to the current study.
(11)Individuals with excessive alcohol-drinking behaviors.
(12)Individuals who can't stop drinking for the days before the pre-check day and check days.
(13)Individuals who have under treatment or a history of drug addiction and/or alcoholism.
(14)Individuals who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
(15)Individuals who are judged as unsuitable for the study by the investigator for other reason.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toya Hidemasa |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
Address
Oekkusu Bldg10F, 5-31-19, Shiba, Minato-ku, Tokyo
TEL
03-3431-1260
toya@huma-c.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masao Matsuoka |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
Address
Oekkusu Bldg10F, 5-31-19, Shiba, Minato-ku, Tokyo
TEL
03-3431-1260
Homepage URL
matsuoka@huma-c.co.jp
Sponsor or person
Institute
Kirin company
Institute
Department
Personal name
Funding Source
Organization
Kirin company
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
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
| 2018 | Year | 10 | 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
| 2017 | Year | 10 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 20 | Day |
Last modified on
| 2018 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039014
