UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033107 |
|---|---|
| Receipt number | 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 18:59:56 |
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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
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
ke-shimmura@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
