UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020478 |
|---|---|
| Receipt number | R000023657 |
| Scientific Title | Kampo decision support system with automatic questionnair system; a prospective study. |
| Date of disclosure of the study information | 2016/01/07 |
| Last modified on | 2023/03/31 09:49:35 |
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Basic information
Public title
Kampo decision support system with automatic questionnair system; a prospective study.
Acronym
Kampo decision support system
Scientific Title
Kampo decision support system with automatic questionnair system; a prospective study.
Scientific Title:Acronym
Kampo decision support system
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to build a Kampo decision support system
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Not applicable
Key secondary outcomes
Not applicable
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who made their first visit to the Kampo Clinics at institutions listed below.
Keio University
Toyama University
Jichi University
Chiba University
Tokyo Women's Medical University
Iizuka Hospital
Kameda Medical center
Hiroshima University
Tohoku University
Key exclusion criteria
Patients who do not want to enter this study.
Target sample size
12000
Research contact person
Name of lead principal investigator
| 1st name | Tetsuhiro |
| Middle name | |
| Last name | Yoshino |
Organization
Keio University School of Medicine
Division name
Center for Kampo Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5366-3824
tetta213@keio.jp
Public contact
Name of contact person
| 1st name | Tetsuhiro |
| Middle name | |
| Last name | Yoshino |
Organization
Keio University School of Medicine
Division name
Center for Kampo Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5366-3824
Homepage URL
https://www.keio-kampo.jp/ja_2/page07.html
tetta213@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Human Genome Center, The Institute of Medical Science, The University of Tokyo
Center for Disease Biology and Integrative Medicine, The University of Tokyo
Kyushu University Education Innovation Initiative
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku, Tokyo, JAPAN
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
慶應義塾大学医学部漢方医学センター外来
慶應義塾大学薬学部
富山大学病院
自治医科大学病院
千葉大学病院
東京女子医科大学東洋医学研究所
麻生 飯塚病院東洋医学センター（漢方診療科）
医療法人鉄蕉会亀田メディカルセンター 東洋医学診療科
広島大学総合診療科漢方診療センター
東北大学病院漢方内科
東京大学医科学研究所ヒトゲノム解析センター
東京大学大学院医学系研究科疾患生命工学センター
九州大学 教育改革推進本部
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 07 | Day |
Related information
URL releasing protocol
http://www.keio-kampo.jp/ja_2/page13.html
Publication of results
Partially published
Result
URL related to results and publications
https://www.keio-kampo.jp/ja_2/page07.html
Number of participants that the trial has enrolled
Results
Based on the medical information, we succeeded in predicting the diagnosis of excess-deficiency, cold-heat, and qi-stagnation by Kampo specialists.
We reported the epidemiological status of cold hypersensitivity in the Kampo clinic.
Based on medical information, we predicted the prescription choices of Kampo specialists.
The relationship between pseudohyperaldosteronism and high direct bilirubin levels was noted.
We noted that renal function improves with the use of prescriptions containing astragalus root.
Results date posted
| 2022 | Year | 07 | Month | 17 | Day |
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
Open public recruiting
Date of protocol fixation
| 2008 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2008 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We analyze medical records retrospectively.
Management information
Registered date
| 2016 | Year | 01 | Month | 07 | Day |
Last modified on
| 2023 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023657
