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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039252
Receipt No. R000044640
Scientific Title Clinical investigation of ninjinyoeito for psychological symptoms, appetite and fatigue among frail elderly males following cystectomy: a preliminary study
Date of disclosure of the study information 2020/01/26
Last modified on 2021/01/26

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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

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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