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Recruitment status Terminated
Unique ID issued by UMIN UMIN000033107
Receipt No. R000037730
Scientific Title Prospective study regarding the improving effect of Ninjinyoeito on frailty and sarcopenia in older adults
Date of disclosure of the study information 2018/06/23
Last modified on 2019/03/14

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Basic information
Public title Prospective study regarding the improving effect of Ninjinyoeito on frailty and sarcopenia in older adults
Acronym The effect of Ninjinyoeito on frailty and sarcopenia
Scientific Title Prospective study regarding the improving effect of Ninjinyoeito on frailty and sarcopenia in older adults
Scientific Title:Acronym The effect of Ninjinyoeito on frailty and sarcopenia
Region
Japan

Condition
Condition Older adults with frailty or prefrailty
Classification by specialty
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate whether Ninjinyoeito,a Kampo Medicine, is effective for treating older adults with frailty or prefrailty.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes in appetite, dietary composition, and physical activity.
Key secondary outcomes Changes in the component of frailty, MMSE score, and body compositoin.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treatment with Ninjinyoeito for 24 weeks
Interventions/Control_2 Observation without treatment for 24 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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. 65 years old or older
2. Outpatient who can walk by himself
3. MMSE score more than 24 points
4. Patient applicable of more than one item of frailty by J-CHS
5. Patient who does not correspond to exclusion criteria
Key exclusion criteria 1. Patient who has allergic episode with Ninjinyoeito in the past
2. Patient who took Kampo medicine preparation within two weeks before examination
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Shinmura
Organization Hyogo College of Medicine
Division name Division of General Medicine, Department of Internal Medicine
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL 0798-45-6865
Email ke-shimmura@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken Shinmura
Organization Hyogo College of Medicine
Division name Division of General Medicine, Department of Internal Medicine
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL 0798-45-6865
Homepage URL
Email ke-shimmura@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 兵庫医科大学ささやま医療センター

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 23 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 Terminated
Date of protocol fixation
2017 Year 07 Month 01 Day
Date of IRB
2017 Year 09 Month 22 Day
Anticipated trial start date
2017 Year 09 Month 23 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information Because the necessary numerical cases did not gather, I decided to terminate this examination.

Management information
Registered date
2018 Year 06 Month 22 Day
Last modified on
2019 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037730

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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