UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052058 |
|---|---|
| Receipt number | R000059415 |
| Scientific Title | A single-center, prospective, open-label study investigating the effect of Ninjin'yoeito on frailty in hemodialysis patients. |
| Date of disclosure of the study information | 2023/08/31 |
| Last modified on | 2025/03/04 13:52:50 |
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Basic information
Public title
A single-center, prospective, open-label study investigating the effect of Ninjin'yoeito on frailty in hemodialysis patients.
Acronym
Effects of Ninjin'yoeito on frailty in hemodialysis patients.
Scientific Title
A single-center, prospective, open-label study investigating the effect of Ninjin'yoeito on frailty in hemodialysis patients.
Scientific Title:Acronym
Effects of Ninjin'yoeito on frailty in hemodialysis patients.
Region
| Japan |
Condition
Condition
frailty in hemodialysis patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of Ninjin'yoeito on frailty in hemodialysis patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood collection data, muscle mass, physical function, weight, and Quality of Life at the start of oral use and one year after
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Kracie Ninjin'yoeito, 7.5g per day, 1year
Interventions/Control_2
No Kracie Ninjin'yoeito medication
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who have been on hemodialysis at our outpatient department for more than 3 months at the start of the study.
2.Patients who have provided consent for participation.
Key exclusion criteria
1. Patients who have difficulty obtaining consent due to dementia
2. Patients with terminal cancer, with acute cardiovascular disease, before and after surgery, and with serious trauma.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Chiaki |
| Middle name | |
| Last name | Kawabata |
Organization
Japanese Red Cross Kumamoto Hospital
Division name
Department of Nephrology
Zip code
861-8520
Address
2-1-1, Nagamineminami, Higashi-ku, Kumamoto city, Kumamoto
TEL
096-384-2111
chiaki-kawabata@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Chiaki |
| Middle name | |
| Last name | Kawabata |
Organization
Japanese Red Cross Kumamoto Hospital
Division name
Department of Nephrology
Zip code
861-8520
Address
2-1-1, Nagamineminami, Higashi-ku, Kumamoto city, Kumamoto
TEL
096-384-2111
Homepage URL
chiaki-kawabata@hotmail.co.jp
Sponsor or person
Institute
Japanese Red Cross Kumamoto Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Committee of Kumamoto Red Cross Hospital
Address
2-1-1, Nagamineminami, Higashi-ku, Kumamoto city, Kumamoto
Tel
0963842111
rinsyoukenkyu@kumamoto-med.jrc.or.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 31 | 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
| 2023 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 30 | Day |
Last modified on
| 2025 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059415
