UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035979 |
|---|---|
| Receipt number | R000040980 |
| Scientific Title | Clinical investigation of ninjin'yoeito on the recovery phase of inpatients with acute illness. |
| Date of disclosure of the study information | 2019/02/22 |
| Last modified on | 2024/02/29 18:04:37 |
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Basic information
Public title
Clinical investigation of ninjin'yoeito on the recovery phase of inpatients with acute illness.
Acronym
Effect of ninjin'yoeito on the recovery phase in inpatients with acute illness.
Scientific Title
Clinical investigation of ninjin'yoeito on the recovery phase of inpatients with acute illness.
Scientific Title:Acronym
Effect of ninjin'yoeito on the recovery phase in inpatients with acute illness.
Region
| Japan |
Condition
Condition
Inpatients with acute illness
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The subjects are geriatric inpatients with acute illness. We investigate the effect of ninjin'yoeito on the frailty (malnutrition, psychiatric symptoms and physical condition) and hospital readmission.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
4 week and 12 week after administration
1) Incidence of readmission, and mortality
2) Nutritional status: Weight,Body mass index,Serum albumin level
3)muscle strength:grasping power,femur circumference
4)QOL(quality of life):SF-36
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 Extract Granules, 7.5g per day
Interventions/Control_2
no 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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
geriatric patient who hospitalized for acute illness.
the patient who can return for follow-up visit by walking or in a wheelchair after discharge from the hospital.
the patient who satisfies one of the following two conditions,
1) the patient who is between the ages of 65 and 74 years with BMI less than 18.5, 75 years old or older with BMI less than 20.
2) the patient aged 65 years old or older whose serum albumin level at hospital admission is 3.5 mg / dl or less.
Key exclusion criteria
the patient who was judged to be inadequate by the judgment of the examination medical attendant.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Kashima |
Organization
Japanese Red Cross Kumamoto Hospital
Division name
Department of General Internal Medicine
Zip code
861-8520
Address
2-1-1 Nagamine Minami, Higashi-ku, Kumamoto, Japan
TEL
096-384-2111
m-kashima@kumamoto-med.jrc.or.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Kashima |
Organization
Japanese Red Cross Kumamoto Hospital
Division name
Department of General Internal Medicine
Zip code
861-8520
Address
2-1-1 Nagamine Minami, Higashi-ku, Kumamoto, Japan
TEL
096-384-2111
Homepage URL
m-kashima@kumamoto-med.jrc.or.jp
Sponsor or person
Institute
Japanese Red Cross Kumamoto Hospital
Institute
Department
Personal name
Funding Source
Organization
Kracie & CO.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto Red Cross Hospital Ethics Committee
Address
2-1-1, higashiku, Nagamineminami, Kumamoto City
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
熊本赤十字病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 22 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000040980
Publication of results
Published
Result
URL related to results and publications
https://www.frontiersin.org/articles/10.3389/fnut.2021.547512/full
Number of participants that the trial has enrolled
7
Results
Three individuals who were administered ginseng nourishing soup showed improvement in SF-36, grip strength, and peripheral blood lymphocyte count compared to four individuals who were not administered the soup.
Results date posted
| 2024 | Year | 02 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Elderly individuals aged 65 and above, who were hospitalized for urinary tract infections and pneumonia, and subsequently discharged to their homes
Participant flow
The conditions were assessed at 4 weeks, 8 weeks, and 12 weeks after discharge.
Adverse events
none
Outcome measures
SF-36, Grip strength, Thigh circumference, Serum albumin, Prognostic Nutritional Index
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 22 | Day |
Last modified on
| 2024 | Year | 02 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040980
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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