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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029976
Receipt No. R000034238
Scientific Title Treatment with Ninjinyoeito for Fatigue in Frail Patients: A Randomized, Parallel-group Comparison Exploratory Study, Including Exploration of Relationship with Intestinal Flora
Date of disclosure of the study information 2017/11/20
Last modified on 2019/04/09

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Basic information
Public title Treatment with Ninjinyoeito for Fatigue in Frail Patients: A Randomized, Parallel-group Comparison Exploratory Study, Including Exploration of Relationship with Intestinal Flora
Acronym A Randomized, Parallel-group Comparison Exploratory Study of Ninjinyoeito for Fatigue in Frail Patients (eF3 Study)
Scientific Title Treatment with Ninjinyoeito for Fatigue in Frail Patients: A Randomized, Parallel-group Comparison Exploratory Study, Including Exploration of Relationship with Intestinal Flora
Scientific Title:Acronym A Randomized, Parallel-group Comparison Exploratory Study of Ninjinyoeito for Fatigue in Frail Patients (eF3 Study)
Region
Japan

Condition
Condition Frailty
Classification by specialty
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate the efficacy and safety of ninjinyoeito on fatigue in cognitive frail patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Fatigue: Chalder's fatigue scale at 24 weeks
Key secondary outcomes 24 weeks
1.Appetite: SNAQ-JE, Simplified Nutritional Appetite Questionnaire for the Japanese elderly
2.The Kihon Checklist
3.Activity: Actigraph
4.Body composition: body weight, lean body mass/fat mass
5. Physical performance: SPPB, Short Physical Performance Battery, handgrip strength
6. Cognitive function:MINI-Mental State Examination, National Center for Geriatrics and Gerontology-Functional Assessment Tool

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 TSUMURA Ninjinyoeito Extract Granules, 9g per day, 24 weeks
Interventions/Control_2 No treatment
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Frail or pre-frail patient: the Kihon Checklist > 3 points
2. Patient who answered yes on the Kihon Checklist No. 25 for fatigue at baseline
3. Patient who has possessed of MMSE score > 23 points, and >0 points on the sum of Kihon Checklist No. 18-20 for cognitive dysfunction at baseline
Key exclusion criteria 1. Patient who has had surgical resection of gastrointestinal tract or under the treatment for gastrointestinal disturbance
2. Dementia, major depression or bipolar disorder within the previous year, and alcoholism, drug addiction, within the previous 2 years
3. Patients who has life-threatening diseases such as malignant tumor
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Hidenori
Middle name
Last name Arai
Organization National Center Geriatrics and Gerontology
Division name Center for Gerontology and Social Science
Zip code 474-0038
Address 7-430 Morioka-cho, Obu, Aichi, 474-8511, Japan
TEL 0562-46-2311
Email harai@ncgg.go.jp

Public contact
Name of contact person
1st name Hidenori
Middle name
Last name Arai
Organization National Center Geriatrics and Gerontology
Division name Center for Gerontology and Social Science
Zip code 474-0038
Address 7-430 Morioka-cho, Obu, Aichi, 474-8511, Japan
TEL 0562-46-2311
Homepage URL
Email harai@ncgg.go.jp

Sponsor
Institute National Center Geriatrics and Gerontology
Institute
Department

Funding Source
Organization Tsumura & CO.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Nagoya Institute of Technology
Kurume University
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Center Geriatrics and Gerontology
Address 7-430 Morioka-cho, Obu, Aichi, 474-8511, Japan
Tel 0562-46-2311
Email sumiyami@ncgg.go.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 国立長寿医療研究センター

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 20 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
2017 Year 09 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 20 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 11 Month 15 Day
Last modified on
2019 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034238

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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