UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021332 |
|---|---|
| Receipt number | R000022961 |
| Scientific Title | The evaluation of the effect of jyuzentaihoto on fatigue and NK cell function |
| Date of disclosure of the study information | 2016/03/04 |
| Last modified on | 2021/03/08 09:45:35 |
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Basic information
Public title
The evaluation of the effect of jyuzentaihoto on fatigue and NK cell function
Acronym
The evaluation of the effect of jyuzentaihoto on fatigue and NK cell function
Scientific Title
The evaluation of the effect of jyuzentaihoto on fatigue and NK cell function
Scientific Title:Acronym
The evaluation of the effect of jyuzentaihoto on fatigue and NK cell function
Region
| Japan |
Condition
Condition
fatigue
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of the effect of jyuzentaihoto on NK cell function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
NK cell function
Key secondary outcomes
Numerical Rating Scale and questionnaires of general fatigue
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
jyuzentaihoto
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
No subjective symptom, drinking three times or less a week, and normal liver and renal function that has been confirmed in a medical examination within one year.
Key exclusion criteria
Any of the following: currently receiving a drug therapy, currently having chronic diseases such as heart, lung, kidney, gastrointestinal, and inflammatory diseases, suffering from invasive cancer within five years, suffering from non-invasive cancer within a year, and a history of smoking within one year.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Keiko Ogawa |
Organization
Kanazawa University Hospital
Division name
Department of Kampo Medicine
Zip code
920-8641
Address
13-1 ,Takara-machi, Kanazawa
TEL
076-265-2918
okeiko@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Ogawa |
Organization
Kanazawa University Hospital
Division name
Department of Kampo Medicine
Zip code
920-8641
Address
Kanazawa
TEL
09060322222
Homepage URL
okeiko@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanazawa University Hospital
Address
13-1, Takara-machi,Kanazawa
Tel
09060322222
ikkandoo@gmail.com
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
金沢大学附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 04 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 04 | Day |
Last modified on
| 2021 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022961
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
