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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042505
Receipt No. 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 2020/11/19

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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
Email 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
Email m_kohno@jintan.co.jp

Sponsor
Institute Morishita Jintan Co., Ltd.
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 17 Day
Date of IRB
2020 Year 07 Month 31 Day
Anticipated trial start date
2020 Year 11 Month 21 Day
Last follow-up date
2023 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
2020 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048516

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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