UMIN-CTR Clinical Trial

Basic information
Public title	Randomized Clinical Trial; the effect of Bangle Rhizome on mild cognitive impairment
Acronym	the effect of Bangle Rhizome on mild cognitive impairment
Scientific Title	Randomized Clinical Trial; the effect of Bangle Rhizome on mild cognitive impairment
Scientific Title:Acronym	RCT Bangle Rhizomeon MCI
Region	Japan

Condition
Condition	healthy elderly with MCI
Classification by specialty	Geriatrics Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verify that ingestion of Bangle Rhizomeextract is effective in maintaining and improving cognitive function in people with mild cognitive impairment
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cognitive function evaluation
Key secondary outcomes	Changes in oral bacterial flora, taste threshold, dietary intake, ADL assessment

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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Bangle Rhizome 600 mg/day
Interventions/Control_2	Bangle Rhizome 300mg/day
Interventions/Control_3	placebo
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	65 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Elderly people who are healthy and maintain their daily activities, but have mild cognitive decline, and who have given their consent to the study. Persons with an MMSE rating of 24 points or more and 27 points or less Organ function: Those who do not find any obvious abnormal values in blood tests
Key exclusion criteria	(1) Persons suffering from serious cerebrovascular disease, heart disease, liver disease, renal disease, gastrointestinal disease, infectious disease requiring notification, etc. (2) Those who are diagnosed with overt dementia (3) Chronic diseases (diabetes, heart disease, liver failure, renal failure, gastric / duodenal ulcer, colitis, Those who are being treated or taking medication due to Crohn's disease, cancer, etc.) (4) Persons with significant abnormalities in blood pressure measurement and blood test (5) Persons with severe anemia, malnutrition, or bleeding tendency (6) Those who frequently have diarrhea symptoms (7) Persons who may show allergic symptoms to the subject (8) Excessive smoking and alcohol addicts and those with extremely irregular lifestyle habits such as eating and sleeping (9) Those who are currently participating in other clinical trials or who have participated within one month (10) Others who are judged to be ineligible by the tester
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Rie Middle name Last name Tsutsumi
Organization	Tokushima University
Division name	Department of Metabolism and Nutrition
Zip code	7708503
Address	3-18-15 Kumamoto, Tokushima
TEL	81-88-633-9249
Email	rtsutsumi@tokushima-u.ac.jp

Public contact
Name of contact person	1st name Rie Middle name Last name Tsutsumi
Organization	Tokushima University
Division name	Department of Metabolism and Nutrition
Zip code	7708503
Address	3-18-15 Kumamoto, Tokushima
TEL	81-88-633-9249
Homepage URL
Email	rtsutsumi@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University
Institute
Department

Funding Source
Organization	Tokushima University
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	Tokushima University Hospital
Address	2-50-1 Kuramoto Tokushima
Tel	81-88-633-615-8512
Email	fiest-ec@tokushima-u.ac.jp

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	徳島大学

Other administrative information
Date of disclosure of the study information	2021 Year 11 Month 01 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	2021 Year 01 Month 15 Day
Date of IRB	2021 Year 02 Month 28 Day
Anticipated trial start date	2021 Year 11 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 11 Month 01 Day
Last modified on	2021 Year 11 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052444