UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	To investigate the effect of siberian carrot extract for intra ocular pressure and circulation
Title of the study (Brief title)	Assessment of ocular function with siberian carrot extract
Region	Japan

Condition
Condition	glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the control of intra ocular pressure and blood circulation of ocular tissue
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Downegulate of ocular pressure and increas the blood flow at ocular tissue
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type

Study design
Basic design	Single arm
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	One month after treament, control should be perfomed.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	healthy person
Key exclusion criteria	disease person
Target sample size	40

Research contact person
Name of lead principal investigator	Kazuichi Maruyama
Organization	Tohoku University Graudate School of Medicine
Division name	Ophthalmology
Address	1-1 Seiryo-machi Aobaku, Sendai
TEL	022-717-7294
Email	maruyama-k@oph.med.tohoku.ac.jp

Public contact
Name of contact person	Kazuichi Maruyama
Organization	Tohoku University Graudate School of Medicine
Division name	Ophthalmology
Address	1-1 Seiryo-machi Aobaku, Sendai
TEL	022-717-7294
Homepage URL
Email	maruyama-k@oph.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graudate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Tohoku University Graudate School of Medicine
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 09 Month 24 Day
Anticipated trial start date	2013 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 04 Month 30 Day
Last modified on	2016 Year 05 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013977