Unique ID issued by UMIN | UMIN000020684 |
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Receipt number | R000023869 |
Scientific Title | The validation study for improvement of visual fatigue in healthy Japanese: a double-blind, randomized, placebo-controlled, and parallel trial |
Date of disclosure of the study information | 2016/01/21 |
Last modified on | 2017/03/01 17:19:46 |
The validation study for improvement of visual fatigue in healthy Japanese: a double-blind, randomized, placebo-controlled, and parallel trial
The validation study for visual fatigue in healthy Japanese
The validation study for improvement of visual fatigue in healthy Japanese: a double-blind, randomized, placebo-controlled, and parallel trial
The validation study for visual fatigue in healthy Japanese
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
To investigate the effect of the test food to improve of visual fatigue caused by visual display terminal (VDT) in healthy Japanese adults
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
1. Miosis frequency (at 0 week and 4 weeks after)
* Perform the test before and after VDT for 45 minutes
1. Flicker test (at 0 week and 4 weeks after)
* Perform the test before and after VDT for 45 minutes
2. subjective symptoms (at 0 week and 4 weeks after)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Treatment
Food |
Period: 4 weeks
Test food: Aronia tablet
Dose: 5 tablets a day
Usage: intake at optional timing
Period: 4 weeks
Test food: placebo tablet
Dose: 5 tablets a day
Usage: intake at optional timing
20 | years-old | <= |
Not applicable |
Male and Female
1. Healthy Japanese men and women
2. Persons who are aware of visual fatigue
3. Persons who usually play TV games, use PC, or perform VDT for more than 4 hours a day.
4. Persons whose corrected visual acuity in both eyes is > 1.0, and who do not wear contact lenses.
1. Persons who have previous medical history of malignant tumor, heart failure or myocardial infarction
2. Patients who are currently under the treatment for either atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases
3. Patients who were diagnosed as presbyopia or are aware of presbyopia
4. Patients who have eye disease such as entropion or trichiasis
5. Patients who have uncorrected refractive errors
6. Patients who have astigmatism
7. Patients who have cause of visual fatigue except regulatory function such as nerve function, etc.
8. Persons who usually take pharmaceuticals (include herbal medicine), health-promoting diet and health food for the purpose of health maintenance
9. Persons who are allergic to medicines or foods related to the test food of this trial
10. Persons who have allergy to pollinosis
11. Persons who are pregnant, lactating, or planning to get pregnant during the trial period
12. Persons who were enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial
13. Persons who are judged unsuitable for participating in this trial by physician
24
1st name | |
Middle name | |
Last name | Kazuo YAMAMOTO |
ORTHOMEDICO, Inc.
R&D Department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
03-3818-0610
kazu@orthomedico.jp
1st name | |
Middle name | |
Last name | Naoko SUZUKI |
ORTHOMEDICO, Inc.
R&D Department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO, Inc.
Public Interest Incorporated Foundation, Northern Advancement Center for Science & Technology
Non profit foundation
Seishin-kai Medical Association Inc, Takara Medical Clinic.
NO
医療法人社団 盛心会 タカラクリニック (東京都)
Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)
2016 | Year | 01 | Month | 21 | Day |
Published
Suzuki N, Sugawara M, Kudo M, Yamada T. Effects of Aronia Berry Intake on Eye Fatigue-A randomized Double-blind Placebo-controlled Trial-. Jpn Pharmacol Ther 2017; 45(2): 211-220.
Completed
2016 | Year | 01 | Month | 18 | Day |
2016 | Year | 01 | Month | 21 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 01 | Month | 21 | Day |
2017 | Year | 03 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023869
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