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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035979
Receipt No. 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 2019/02/22

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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
Middle name
Last name Masayuki Kashima
Organization Japanese Red Cross Kumamoto Hospital
Division name Department of General Internal Medicine
Zip code
Address 2-1-1 Nagamine Minami, Higashi-ku, Kumamoto, Japan
TEL 096-384-2111
Email m-kashima@kumamoto-med.jrc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Kashima
Organization Japanese Red Cross Kumamoto Hospital
Division name Department of General Internal Medicine
Zip code
Address 2-1-1 Nagamine Minami, Higashi-ku, Kumamoto, Japan
TEL 096-384-2111
Homepage URL
Email m-kashima@kumamoto-med.jrc.or.jp

Sponsor
Institute Japanese Red Cross Kumamoto Hospital
Institute
Department

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
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 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
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 Enrolling by invitation
Date of protocol fixation
2017 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
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
2019 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040980

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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