UMIN-CTR Clinical Trial

Basic information
Public title	Clinical investigation of ninjinyoeito for psychological symptoms, appetite and fatigue among frail elderly males following cystectomy: a preliminary study
Acronym	Effects of ninjinyoeito on psychological symptoms, appetite and fatigue in frail elderly males following cystectomy
Scientific Title	Clinical investigation of ninjinyoeito for psychological symptoms, appetite and fatigue among frail elderly males following cystectomy: a preliminary study
Scientific Title:Acronym	Effects of ninjinyoeito on psychological symptoms, appetite and fatigue in frail elderly males following cystectomy
Region	Japan

Condition
Condition	frailty
Classification by specialty	Geriatrics Urology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate the efficacy of ninjinyoeito on psychological symptoms, appetite and fatigue in frail elderly male following cystectomy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Psychological examination measured by POMS2 at 8 weeks
Key secondary outcomes	1) Simplified Nutritional Appetite Questionnaire score 2) Chalder Fatigue Scale at 8 weeks 3) Levels of salivary stress biomarkers at 8 weeks

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	TUMURA Ninjinyoeito, 9.0g per day, 12weeks
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	70 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	1) At 6 months or later after surgery Patients with frailty (J-CHS criteria). 2) Patients who have provided consent for participation.
Key exclusion criteria	1) Patients with severe comorbidity. 2) Patients with severe cognitive impairment. 3) Patients whom investigators consider to be ineligible.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Akemi Middle name Last name Yamashita
Organization	Koto Hospital
Division name	Department of Urology
Zip code	136-0072
Address	6-8-5 Koto-ku, Ojima, Tokyo, Japan
TEL	0336852166
Email	akeyamasit@yahoo.co.jp

Public contact
Name of contact person	1st name Akemi Middle name Last name Yamashita
Organization	Koto Hospital
Division name	Department of Urology
Zip code	136-0072
Address	6-8-5 Koto-ku, Ojima, Tokyo, Japan
TEL	0336852166
Homepage URL
Email	akeyamasit@yahoo.co.jp

Sponsor
Institute	Koto Hospital
Institute
Department

Funding Source
Organization	Koto Hospital
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	Depatrment of General Affairs, Koto Hospital
Address	6-8-5 Koto-ku, Ojima, Tokyo, Japan
Tel	03- 3685-2166
Email	soumu-s@koto-hospital.or.jp

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	2020 Year 01 Month 26 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	2019 Year 12 Month 01 Day
Date of IRB	2020 Year 01 Month 15 Day
Anticipated trial start date	2020 Year 01 Month 15 Day
Last follow-up date	2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 01 Month 24 Day
Last modified on	2021 Year 01 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044640