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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034582
Receipt No. 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

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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
Email 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
Email hiraik@med.showa-u.ac.jp

Sponsor
Institute Showa University School of Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033969

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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