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
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
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
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 | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
