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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000022223
Receipt No. R000025590
Scientific Title Study of safety and usefulness of Java ginger Bangle against the cognitive decline in the elderly (Phase 2 clinical trial as a food)
Date of disclosure of the study information 2016/05/09
Last modified on 2016/05/06

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Basic information
Public title Study of safety and usefulness of Java ginger Bangle against the cognitive decline in the elderly
(Phase 2 clinical trial as a food)
Acronym Safety and usefulness of Bangle against connitive decline
Scientific Title Study of safety and usefulness of Java ginger Bangle against the cognitive decline in the elderly
(Phase 2 clinical trial as a food)
Scientific Title:Acronym Safety and usefulness of Bangle against connitive decline
Region
Japan

Condition
Condition Alzheimer's disease
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the safety and efficacy of Java ginger Bangle for the mild cognitive impairment of the age-related progression
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes MMSE
Key secondary outcomes Trail Making
MENFIS
Barthel Index
NPI-Q
Adverse event

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Food containing Bangle, 1 per serving
(48weeks)
Interventions/Control_2 Food not containing Bangle, 1 per serving
(48weeks)
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1)males and females aged 60 to 80 years old.
2)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria 1)Subject suffering from a malignant tumor
2)Subject suffering from diseases that are severe heart disease, liver disease, blood disease, lung disease and disease that affects life
3)Subject that oral administration is not possible
4)Subject that research attendingt physician determines inappropriate
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhiko Miyamura
Organization Kochi Medical school Hospital
Division name Pharmacy
Zip code
Address Kohasu, Oko-cho, Nankoku-shi, Kochi
TEL 088-880-2549
Email jm-kouheij@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kohei Jobu
Organization Kochi Medical school Hospital
Division name Pharmacy
Zip code
Address Kohasu, Oko-cho, Nankoku-shi, Kochi
TEL 088-880-2549
Homepage URL
Email jm-kouheij@kochi-u.ac.jp

Sponsor
Institute Kochi Medical school Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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
2016 Year 05 Month 09 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 Enrolling by invitation
Date of protocol fixation
2015 Year 12 Month 09 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 09 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
2016 Year 05 Month 06 Day
Last modified on
2016 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025590

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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