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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000029156 |
Receipt No. | R000033324 |
Scientific Title | Effects of a Food Containing Extract of bilberry/bulk of pine intake on ocular blood flow in healthy adults. |
Date of disclosure of the study information | 2018/03/10 |
Last modified on | 2019/03/26 |
Basic information | ||
Public title | Effects of a Food Containing Extract of bilberry/bulk of pine intake on ocular blood flow in healthy adults. | |
Acronym | Ocular blood flow study of bilberry/bulk of pine extracts | |
Scientific Title | Effects of a Food Containing Extract of bilberry/bulk of pine intake on ocular blood flow in healthy adults. | |
Scientific Title:Acronym | Ocular blood flow study of bilberry/bulk of pine extracts | |
Region |
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Condition | |||
Condition | N/A (Healthy adults) | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | This study examines effects of test food on ocular blood flow in healthy adults. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Value and rate changes of optic nerve blood flow from pre-dosing at 4, 8 and 12 weeks after dosing
Adverse effect |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | Oral intake of test food (1 pill in once a day, 12 weeks) | |
Interventions/Control_2 | ||
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | [1]Males and Females aged 20 years over
[2] Individuals whose written informed consent has been obtained [3]Individuals who can have an examination in a designated day [4]Individuals without ocular disease except ametropia [5]Individuals whose ocular blood flow can stably measured |
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Key exclusion criteria | [1] Individuals with serious disease
[2] Individuals with cigarettes smoker [3]Individuals with cardiac failure, renal failure, hepatitis B or C, Hyperlipidemia, hypotension, hypertension, diabetes or a history of the said diseases [4]Individuals who continuously used a antioxidative supplement (ex. bulk of pine extracts, bilberry, blackcurrant, rutein, astaxanthin, vitamin E) or have plan to use said supplements during the study period [5] Individuals who used a drug having influence to ocular blood flow (ex. antihypertensive agents, circulation improving drugs) in the past 4 weeks. [6] Individuals who is pregnant, lactating, or may possibly be pregnant. [7] Individuals who entry into another clinical trial, or has a history of the entry into other clinical trials within 3 months [8] Individuals with allergy to test food or who may possibly be allergy to test food, or with severe allegy to other foods or drugs. [9] Individuals who are inappropriate case judged by investigator or subinvestigators. |
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Target sample size | 14 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Santen Pharmaceutical Co., Ltd. | ||||||
Division name | Japan Medical Affairs Group, Development Management Department, Japan Business | ||||||
Zip code | 530-8552 | ||||||
Address | 4-20, Ofukacho, Kita-ku, Osaka | ||||||
TEL | 06-4802-9337 | ||||||
clinical@santen.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Santen Pharmaceutical Co., Ltd. | ||||||
Division name | Japan Medical Affairs Group, Development Management Department, Japan Business | ||||||
Zip code | 530-8552 | ||||||
Address | 4-20, Ofukacho, Kita-ku, Osaka | ||||||
TEL | 06-4802-9337 | ||||||
Homepage URL | |||||||
clinical@santen.co.jp |
Sponsor | |
Institute | Santen Pharmaceutical Co., Ltd. |
Institute | |
Department |
Funding Source | |
Organization | Santen Pharmaceutical Co., Ltd. |
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 | Kitasato University IRB |
Address | 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0375, Japan |
Tel | 042-778-8273 |
rinrib@med.kitasato-u.ac.jp |
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 | 北里大学病院(Kitasato University Hospital) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |||||||
URL related to results and publications | |||||||
Number of participants that the trial has enrolled | 14 | ||||||
Results | In this few cases study,the significant increase in ocular blood flow was not observed. | ||||||
Results date posted |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033324 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |