UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037092 |
|---|---|
| Receipt number | R000042266 |
| Scientific Title | Pharmacokinetic of quercetin in tears following oral ingestion |
| Date of disclosure of the study information | 2019/06/18 |
| Last modified on | 2019/06/17 20:26:53 |
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Basic information
Public title
Pharmacokinetic of quercetin in tears following oral ingestion
Acronym
Effect of quercetin-rich onion on lacrimal gland function
Scientific Title
Pharmacokinetic of quercetin in tears following oral ingestion
Scientific Title:Acronym
Effect of quercetin-rich onion on lacrimal gland function
Region
| Japan |
Condition
Condition
dry eye disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of quercetin-rich onion in lacrimal gland function
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Concentration of quercetin in tear
Concentration of quercetin in serum
Key secondary outcomes
Tear production
Tear film breakup time
Fuorescein corneal staining
Questionnaire
Concentration of oxidative stress marker in tear
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Onion powder (quercetin high amount) 23g/day for five days.
Interventions/Control_2
Onion powder (quercetin low amount) 23g/day for five days.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects who do not have any systemic diseases that may influence on the wound healing of eyes such as diabetes
Key exclusion criteria
Subjects who do not agree with tear collection
Taking supplements
Smokers
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Shimazaki |
Organization
Tokyo Dental College, Ichikawa General Hospital
Division name
Ophthalmology
Zip code
272-8513
Address
5-11-13 Sugano, Ichikawa, Chiba, Japan
TEL
047-322-0151
jun@eyebank.or.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Inaba |
Organization
Tokyo Dental College, Ichikawa General Hospital
Division name
Ophthalmology
Zip code
272-8512
Address
5-11-13 Sugano, Ichikawa, Chiba, Japan
TEL
047-322-0151
Homepage URL
Prosuta@yahoo.co.jp
Sponsor or person
Institute
Tokyo Dental College
Institute
Department
Personal name
Funding Source
Organization
National Agriculture and Food Research Organization
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Tokyo Dental College, Ichikawa General Hospital
Address
5-11-13 Sugano, Ichikawa, Chiba, Japan
Tel
0473220151
jun@eyebank.or.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
東京歯科大学市川総合病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 18 | 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
10
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
| 2011 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2011 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2011 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 17 | Day |
Last modified on
| 2019 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042266
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
