UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039252 |
|---|---|
| Receipt number | 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 16:28:12 |
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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
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
akeyamasit@yahoo.co.jp
Sponsor or person
Institute
Koto Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044640
