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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000026566 |
Receipt No. | R000030502 |
Scientific Title | A study evaluating the efficacy of botanical ingredient-containing food on eye strain. |
Date of disclosure of the study information | 2018/03/14 |
Last modified on | 2017/10/31 |
Basic information | ||
Public title | A study evaluating the efficacy 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 efficacy 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 |
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Condition | ||
Condition | Healthy adults | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kirin Company | ||||||
Division name | Research & Development Division, Resarch Laboratories for Health Science & Food Technologies | ||||||
Zip code | |||||||
Address | 1-17-1, Namamugi, Tsurumi-ku, Yokohama, Kanagawa | ||||||
TEL | 045-500-6970 | ||||||
Yasuji_Kawachi@kirin.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kirin Company | ||||||
Division name | Research & Development Division, Resarch Laboratories for Health Science & Food Technologies | ||||||
Zip code | |||||||
Address | 1-17-1, Namamugi, Tsurumi-ku, Yokohama, Kanagawa | ||||||
TEL | 045-500-6970 | ||||||
Homepage URL | |||||||
Yasuji_Kawachi@kirin.co.jp |
Sponsor | |
Institute | Kirin Company |
Institute | |
Department |
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 | キリン株式会社 |
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 | |
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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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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=R000030502 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |