UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003818 |
|---|---|
| Receipt number | R000004603 |
| Scientific Title | Study in the effect of Citrus Reticulata peels on the cognitive function in the patients with Alzheimer Disease |
| Date of disclosure of the study information | 2010/06/24 |
| Last modified on | 2016/06/24 18:59:59 |
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Basic information
Public title
Study in the effect of Citrus Reticulata peels on the cognitive function in the patients with Alzheimer Disease
Acronym
Study in the effect of Citrus Reticulata peels on the cognitive function in the patients with Alzheimer Disease
Scientific Title
Study in the effect of Citrus Reticulata peels on the cognitive function in the patients with Alzheimer Disease
Scientific Title:Acronym
Study in the effect of Citrus Reticulata peels on the cognitive function in the patients with Alzheimer Disease
Region
| Japan |
Condition
Condition
Alzheimer Disease
Classification by specialty
| Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
study on the effect of Citrus Reticulata peels on the cognitive impairment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
ADAS-cog
MMSE
Key secondary outcomes
NPI
Barthel Index
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ordinary treatment, rehabilitation with oral administration of Citrus Reticulata peels
Interventions/Control_2
ordinary treatment and rehabilitation
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
| 60 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Alzheimer Disease
MMSE score between 13 and 25
Key exclusion criteria
other dementia or mental disease
MMSE score under 13 and over 25
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi SEKI |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Geriatric Behavioral Neurology
Zip code
Address
2-1 seiryo-machi, Aoba-ku, Sendai, Miyagi, JAPAN
TEL
+81-22-717-7359
t-seki@m.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi SEKI |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Geriatric Behavioral Neurology
Zip code
Address
2-1 seiryo-machi, Aoba-ku, Sendai, Miyagi, JAPAN
TEL
+81-22-717-7359
Homepage URL
t-seki@m.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant in Aid of the laboratory
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
大崎市田尻診療所(宮城県）、国立病院機構米沢病院(山形県）、東京医科歯科大学医学部附属病院（東京都）、
近畿大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 24 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 06 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | 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
| 2010 | Year | 06 | Month | 24 | Day |
Last modified on
| 2016 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004603
