UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005915
Receipt number R000006995
Scientific Title Antioxidant nutrients enhanced diet effect on Stroke Study.
Date of disclosure of the study information 2011/07/04
Last modified on 2011/07/04 12:09:06

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Basic information

Public title

Antioxidant nutrients enhanced diet effect on Stroke Study.

Acronym

ANEDESS

Scientific Title

Antioxidant nutrients enhanced diet effect on Stroke Study.

Scientific Title:Acronym

ANEDESS

Region

Japan


Condition

Condition

Stroke

Classification by specialty

Medicine in general Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Study of antioxidant nutrients enhanced diet effect on Stroke.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Antioxidant test.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

ANOM(+)

Interventions/Control_2

ANOM(-)

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

20 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

1)ovre 20years old female or male.
2)Within 1week from onset the Stroke.
3)Cons level within JCS3.

4)agrrement on paper,patients or patient's family.



























































Key exclusion criteria

Child

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name TatsuyaNAKMAURA,MD,PhD

Organization

Tohoku Kouseinenkin Hospital

Division name

Neurology

Zip code


Address

1-12-1Hukumuro,Miyagono-ku,Sendai,MIYAGI JAPAN

TEL

022-259-1221-717

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Tohoku Kouseinenkin Hospital

Division name

Neurology

Zip code


Address


TEL

022-259-1221-717

Homepage URL


Email

tnt.jr@nifty.com


Sponsor or person

Institute

TatsuyaNAKMAURA,MD,PhD

Institute

Department

Personal name



Funding Source

Organization

None.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2011 Year 07 Month 04 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

2011 Year 07 Month 06 Day

Date of IRB


Anticipated trial start date

2011 Year 07 Month 01 Day

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

2011 Year 07 Month 04 Day

Last modified on

2011 Year 07 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006995


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name