UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter study of Kampo treatment for frailty in aged patients
Acronym	Multicenter study of Kampo treatment for frailty in aged patients
Scientific Title	Multicenter study of Kampo treatment for frailty in aged patients
Scientific Title:Acronym	Multicenter study of Kampo treatment for frailty in aged patients
Region	Japan

Condition
Condition	Frailty
Classification by specialty	Medicine in general Psychosomatic Internal Medicine Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the efficacy of Ninjinyoeito, Kampo formulas, for frailty in aged patients on physical activity using activity meter, blood sample and psychological examination.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Number of steps and physical activity
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Ninjinyoeito Administered orally at a dose of 7.5 g/day in two or three divided doses before or between meals. Adjust the dose as needed according to the age, body weight and symptoms of patients. Treatment duration: 3 or 6 months
Interventions/Control_2
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	1)Patients who meet a criterion for frailty 2)ambulatory patients
Key exclusion criteria	1)Patients who have taken crude drug product within 2 weeks before enrollment 2)Patients suspected of having dementia (MMSE score 23 or below) 3)Patients with a history of Parkinson disease or stroke 4)Patients with serious complications (e.g., hepatic or cardiac diseases) 5)Other patients who are assessed to be inappropriate for study participation by the investigator, or other relevant persons
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Akio Inui
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Department of Psychosomatic Internal Medicine
Zip code
Address	8-35-1 Sakuragaoka, Kagoshima City, Kagoshima, Japan
TEL	099-275-5751
Email	inui@m.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Haruka Amitani
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Department of Psychosomatic Internal Medicine
Zip code
Address	8-35-1 Sakuragaoka, Kagoshima City, Kagoshima, Japan
TEL	099-275-5751
Homepage URL
Email	amitani@m3.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Kagoshima University Hospital
Institute
Department

Funding Source
Organization	Kracie Pharmaceutical,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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 03 Month 23 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	2016 Year 10 Month 17 Day
Date of IRB
Anticipated trial start date	2017 Year 03 Month 14 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	2018 Year 03 Month 23 Day
Last modified on	2018 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036383

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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