UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034582 |
|---|---|
| Receipt number | R000033969 |
| Scientific Title | randomized controlled trial of the ninjinyoeito for the copd patient of frailty or prefrailty |
| Date of disclosure of the study information | 2018/10/20 |
| Last modified on | 2019/02/21 12:36:34 |
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Basic information
Public title
randomized controlled trial of the ninjinyoeito for the copd patient of frailty or prefrailty
Acronym
Ninjinyoeito in the copd patient with frailty
Scientific Title
randomized controlled trial of the ninjinyoeito for the copd patient of frailty or prefrailty
Scientific Title:Acronym
Ninjinyoeito in the copd patient with frailty
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of improvement of frailty with the ninjinyoeito or the progress suppressant effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of frailty or prefrailty or progress restraint.
we evaluate it a half year later after giving ninjinyoeito.
Key secondary outcomes
evaluation of changes such as an appetite, mood disorders, a grip, the weight, muscular strength, muscle mass, cat score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ninjinyoeito
Interventions/Control_2
Conventional treatment continuation
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
the patient who receives the treatment with bronchodilator in copd patients.
the patient who corresponds to frailty or prefrailty.
the patient with the smoking history of 10 pack years.
Key exclusion criteria
the patient who cannot perform an examination of respiratory function tests appropriately.
the patient who is complicated with respiratory illness except copd.
the patient who is infected with a disease for some kind of immediate nature period within three months of study entry.
patient with less than in MMSE(Mini-Mental State Examinaton) 18 points.
the patient who has a history of taking Chinese medicine preparation within one month preceding agreement acquisition time.
the patient who is complicated with a malignant tumor with the activity.
the patient who participated in other clinical trials within the past four weeks.
the patient who was judged to be inadequate by the judgment of the examination medical attendant.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sagara Hironori |
Organization
Showa University School of Medicine
Division name
Department of Internal Medicine, Division of Allergology and Respiratory Medicine
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
03-3784-8000
sagarah@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kuniaki Hirai |
Organization
Showa University School of Medicine
Division name
Department of Internal Medicine, Division of Allergology and Respiratory Medicine
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
03-3784-8000
Homepage URL
hiraik@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Showa University School of Medicine
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
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 20 | 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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 20 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 20 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 20 | Day |
Last modified on
| 2019 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033969
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
