UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	randomized controlled trial of the ninjinyoeito for the copd patient of frailty or prefrailty
Title of the study (Brief title)	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	Sagara Hironori
Organization	Showa University School of Medicine
Division name	Department of Internal Medicine, Division of Allergology and Respiratory Medicine
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	Kuniaki Hirai
Organization	Showa University School of Medicine
Division name	Department of Internal Medicine, Division of Allergology and Respiratory Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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