UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042505 |
|---|---|
| Receipt number | R000048516 |
| Scientific Title | Investigation of effects of blackcurrant extract on suppression of myopia progression |
| Date of disclosure of the study information | 2020/11/21 |
| Last modified on | 2021/11/22 16:33:25 |
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Basic information
Public title
Investigation of effects of blackcurrant extract on suppression of myopia progression
Acronym
Investigation of effects of blackcurrant extract on suppression of myopia progression
Scientific Title
Investigation of effects of blackcurrant extract on suppression of myopia progression
Scientific Title:Acronym
Investigation of effects of blackcurrant extract on suppression of myopia progression
Region
| Japan |
Condition
Condition
Japanese healthy children in the ages greater than or equal 9, and less than 12
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of effects of continuous intake of blackcurrant extract for one year on suppression of myopia progression
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eye axial length
Key secondary outcomes
Naked visual acuity, corrected visual acuity, objective refractive index (other-angle refractive index), intraocular pressure, contrast visual acuity, and questionnaire.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 9 | years-old | <= |
Age-upper limit
| 12 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Healthy Japanese children in the ages greater than or equals to 8 and less than 12.(Gender ratio is intended to be 50/50)
(2) A person who understood and agreed with the purpose of the clinical trial. The agreement document from the subject or its proxy is required based on the above understanding prior the clinical trial.
(3) Persons who are able to comply with the requirements of the study, receive the medical examination prescribed in the protocol, and report symptoms and other information.
Key exclusion criteria
(1)Persons who are allergic to the test food
(2)Any other person who is judged by the doctor responsible for the trial as in appropriate to participate in the study.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Katsumi |
Organization
Kashiwa Kibou Ophthalmology
Division name
director
Zip code
277-0922
Address
1-6-1-2F, Oshimada, Kashiwa City, Chiba
TEL
04-7157-0818
o.katsumi729@i.softbank.jp
Public contact
Name of contact person
| 1st name | Mamiko |
| Middle name | |
| Last name | Kohno |
Organization
Morishita Jintan Co., Ltd.
Division name
Health Care Product Department
Zip code
101-0043
Address
10-2-6F, Kanda Tomiyama-cho, Chiyoda-ku, Tokyo
TEL
03-6206-8138
Homepage URL
m_kohno@jintan.co.jp
Sponsor or person
Institute
Morishita Jintan Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Morishita Jintan 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
Social medical corporation sokuinkai kouyou Clinic Clinical Trial Review Committee
Address
3-9 Hiroha-machi, Kitahiroshima City, Hokkaido
Tel
011-372-3900
k-ohno@cli-creative.com
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
かしわ希望眼科（千葉県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 21 | 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
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
On or after November 21, 2020, subject recruitments will be conducted at the facility.
Management information
Registered date
| 2020 | Year | 11 | Month | 19 | Day |
Last modified on
| 2021 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048516
| 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 |
