UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029027
Receipt number R000033129
Scientific Title Study of the efficacy and safety of Java ginger(Bangle, Zingiber purpureum) against cognitive decline in the elderly
Date of disclosure of the study information 2017/09/11
Last modified on 2017/09/01 17:32:50

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Study of the efficacy and safety of Java ginger(Bangle, Zingiber purpureum) against cognitive decline in the elderly

Acronym

Study of the efficacy and safety of Java ginger(Bangle, Zingiber purpureum) against cognitive decline in the elderly

Scientific Title

Study of the efficacy and safety of Java ginger(Bangle, Zingiber purpureum) against cognitive decline in the elderly

Scientific Title:Acronym

Study of the efficacy and safety of Java ginger(Bangle, Zingiber purpureum) against cognitive decline in the elderly

Region

Japan


Condition

Condition

Mild Cognitive Impairment

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Elderly people with dementia and mild cognitive impairment are increasing and are expected to increase in the future.
Therefore, prevention of progression from MCI to dementia and establishment of MCI's preventive method are desired, but correspondence is not sufficient.
Therefore, we aim for the development of food that suppresses decline in cognitive function and examine the effectiveness and safety of Java ginger for the deterioration of cognitive function of the elderly.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

1.Congnitive function(12weeks, 24weeks)
MMSE(Mini-mental State Examination)
MENFIS(Mental Function Impairment Scale)
2.MRI(24weeks)

Key secondary outcomes

1.Effectiveness(12 weeks, 24 weeks)
a:Caution function: Trail Making Test
b:Daily living behavior (ADL): Barthel Index
c:Measurable daily living activities (IADL) scale
d:Behavioral disorders associated with dementia, Mental symptoms (BPSD): NPI-Q (Neuropsychiatric Inventory)
e:Care burden: Zarit nursing care burden scale
2.Safety
a:blood biochemical test(12 weeks, 24 weeks)
b:Drink Record(everyday)


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

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Examination period: 24 weeks from the consent acquisition, 24 weeks observation period after the end of the dose, for a total of 48 weeks
Test food: 3 tablets twice daily (tablets containing 85 mg of Java ginger extract per tablet)
Evaluation timing: Prior to administration, 12 weeks after administration, 24 weeks, 48 weeks

Interventions/Control_2

Test food(placebo): 3 tablets twice daily
Evaluation timing: Prior to administration, 12 weeks after administration, 24 weeks, 48 weeks

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Subjects were those who were diagnosed with mild cognitive impairment (MCI) among those who received Dementia-Related Disease Medical Center in the Kochi Medical School Hospital.

Key exclusion criteria

1. Persons suffering from dementia
2. Serious heart disease, liver disease, kidney disease, blood disease, lung disease, and those suffering from diseases judged to affect life
3. Persons who can not orally administer
4. Others who are deemed inappropriate by the research doctor

Target sample size

20


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, 7838505, Japan

TEL

088-880-2549

Email

im55@kochi-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Junko Yokota

Organization

Kochi Medical School Hospital

Division name

Pharmacy

Zip code


Address

Kohasu, Oko-cho, Nankoku-shi, Kochi, 7838505, Japan

TEL

088-880-2549

Homepage URL


Email

jm-yokotaj@kochi-u.ac.jp


Sponsor or person

Institute

Kochi Medical School Hospital

Institute

Department

Personal name



Funding Source

Organization

HOSODA SHC CO.LTD.

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

2017 Year 09 Month 11 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

Preinitiation

Date of protocol fixation

2017 Year 09 Month 11 Day

Date of IRB


Anticipated trial start date

2017 Year 10 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

2017 Year 09 Month 06 Day

Last modified on

2017 Year 09 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033129


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name