UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029976
Receipt number 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 2023/09/22 14:35:01

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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

President Office

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

Department of Geriatric Medicine

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 or person

Institute

National Center Geriatrics and Gerontology

Institute

Department

Personal name



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

Fujita Health University

Address

1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi

Tel

0562-93-2865

Email

kenshien@fujita-hu.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

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

No longer recruiting

Date of protocol fixation

2017 Year 09 Month 13 Day

Date of IRB

2017 Year 10 Month 03 Day

Anticipated trial start date

2017 Year 11 Month 20 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry

2022 Year 12 Month 31 Day

Date trial data considered complete

2022 Year 12 Month 31 Day

Date analysis concluded

2023 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2017 Year 11 Month 15 Day

Last modified on

2023 Year 09 Month 22 Day



Link to view the page

Value
https://center6.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