Unique ID issued by UMIN | UMIN000021611 |
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Receipt number | R000024927 |
Scientific Title | Effect of bilberry extract supplement against VDT on eye fatigue: a double-blind, randomized placebo-controlled and parallel study |
Date of disclosure of the study information | 2016/03/25 |
Last modified on | 2017/01/30 18:47:22 |
Effect of bilberry extract supplement against VDT on eye fatigue: a double-blind, randomized placebo-controlled and parallel study
Effect of bilberry extract supplement against VDT on eye fatigue
Effect of bilberry extract supplement against VDT on eye fatigue: a double-blind, randomized placebo-controlled and parallel study
Effect of bilberry extract supplement against VDT on eye fatigue
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 terminals (VDT) in healthy Japanese adults
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
1. Miosis frequency (at 0 week and 6 weeks after)
* Perform the test before and after VDT for 60 minutes
1. Flicker test (at 0 week and 6 weeks after)
* Perform the test before and after VDT for 60 minutes
2. Subjective symptoms (at 0 week and 6 weeks after)
* Perform the test before and after VDT for 60 minutes
3. Schirmer's test (at 0 week and 6 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 |
Ingest 120 mg bilberry extract supplements per day for 6 weeks
Ingest placebo supplements for 6 weeks
20 | years-old | <= |
Not applicable |
Male and Female
1. Healthy Japanese adults
2. Persons who are aware of visual fatigue
3. Persons who usually play TV games, use PC, use Smartphone, or perform VDT for more than 4 hours a day.
4. Persons who corrected visual acuity in both eyes is >= 1.0, and who do not wear contact lenses or switch to glasses from contact lenses during the study.
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 severe 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 are pregnant, lactating, or planning to get pregnant during the trial period
11. Persons who were enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial
12. Persons who are judged unsuitable for participating in this trial by physician
20
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.
TOKIWA PHYTOCHEMICAL CO., LTD
Profit organization
Seishin-kai Medical Association Inc, Takara Medical Clinic.
NO
アリオ西新井クリニック眼科 (東京都)
Ario Nishiarai Eye Clinic (Tokyo)
2016 | Year | 03 | Month | 25 | Day |
Published
Nakata A, Yamashita S, Suzuki N, Liang T, Yang J, Yamada T. The Improvement Effect of Bilberry Extract (BILBERON)-Containing Diet on Eye Fatigue and Eye Dryness -A Randomized, Double-blind, Placebo-controlled Parallel-group Comparison Study-. Jpn Pharmacol Ther. 2016; 44(12): 1773-1783.
Completed
2016 | Year | 03 | Month | 14 | Day |
2016 | Year | 03 | Month | 26 | Day |
2016 | Year | 07 | Month | 29 | Day |
2016 | Year | 07 | Month | 29 | Day |
2016 | Year | 07 | Month | 29 | Day |
2016 | Year | 07 | Month | 29 | Day |
2016 | Year | 03 | Month | 25 | Day |
2017 | Year | 01 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024927
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