UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003525 |
|---|---|
| Receipt number | R000003820 |
| Scientific Title | Cross-sectional and cohort study investigating the diagnostic and prognositic function of Kampo (Japanese traditional medicine) findings |
| Date of disclosure of the study information | 2010/04/23 |
| Last modified on | 2025/05/21 18:43:36 |
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Basic information
Public title
Cross-sectional and cohort study investigating the diagnostic and prognositic function of Kampo (Japanese traditional medicine) findings
Acronym
Cross-sectional and cohort study for Kampo (Japanese traditional medicine) findings
Scientific Title
Cross-sectional and cohort study investigating the diagnostic and prognositic function of Kampo (Japanese traditional medicine) findings
Scientific Title:Acronym
Cross-sectional and cohort study for Kampo (Japanese traditional medicine) findings
Region
| Japan |
Condition
Condition
people aged 65 or over
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate its relationship with modern diseases and its prognostic function of Kampo findings
Basic objectives2
Others
Basic objectives -Others
death/cardiovascular event/severe infectious disease/malignant tumor/bone fracture/cognitive function
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
mortality
Key secondary outcomes
cardiovascular event
serious infectious disease
malignancy
bone fracture
cognitive function
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
people aged 65 or over
Key exclusion criteria
people with life-threatening disease
Target sample size
550
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Odaguchi |
Organization
Oriental Medicine Research Center, Kitasato University
Division name
Center for Evidence-Based Medicine
Zip code
108-8642
Address
5-9-1, Shirokane, Minatoku
TEL
03-3444-6161
odaguchi@insti.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Odaguchi |
Organization
Oriental Medicine Research Center, Kitasato University
Division name
Center for Evidence-Based Medicine
Zip code
108-8642
Address
5-9-1, Shirokane, Minatoku
TEL
03-5791-6346
Homepage URL
odaguchi@insti.kitasato-u.ac.jp
Sponsor or person
Institute
Oriental Medicine Research Center, Kitasato University
Institute
Department
Personal name
Funding Source
Organization
The Uehara Memorial
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Ministry of Education, Culture, Sports, Science and Technology
IRB Contact (For public release)
Organization
Kitasato Institute Hospital, Research Ethics Committee
Address
5-9-1, Shirokane, Minatoku
Tel
03-3444-6161
kenkyu@insti.kitasato-u.ac.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
北里大学東洋医学総合研究所（東京都）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | 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
567
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Currently analyzing
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
| 2008 | Year | 07 | Month | 16 | Day |
Date of IRB
| 2008 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
This is a prospective cohort study planned for elucidating the relationship between Kampo findings and the morbidity/mortality in each patient.
Management information
Registered date
| 2010 | Year | 04 | Month | 23 | Day |
Last modified on
| 2025 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003820
