UMIN-CTR Clinical Trial

Basic information
Public title	Kampo decision support system with automatic questionnair system; a retrospective study.
Acronym	Kampo decision support system
Scientific Title	Kampo decision support system with automatic questionnair system; a retrospective 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	1 years-old <=
Age-upper limit	120 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who made their first visit to the Kampo Clinic at Keio University Hospital between April 1st 2005 and March 31st 2007, or May 1st 2008 and December 26th 2010.
Key exclusion criteria	Patients who do not want to enter this study.
Target sample size	4018

Research contact person
Name of lead principal investigator	1st name Masaru Middle name Last name Mimura
Organization	Keio University School of Medicine
Division name	Center for Kampo Medicine
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5366-3824
Email	mimura@keio.jp

Public contact
Name of contact person	1st name Masaru Middle name Last name Mimura
Organization	Keio University School of Medicine
Division name	Center for Kampo Medicine
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5366-3824
Homepage URL
Email	mimura@keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Keio University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Human Genome Center, The Institute of Medical Science, The University of Tokyo School of Engineering, The University of Tokyo
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Keio University Graduate School of Medicine
Address	35 Shinanomachi, Shinjuku, Tokyo, JAPAN
Tel	03-3353-1211
Email	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（東京都）・東京大学医科学研究所ヒトゲノム解析センター（東京都）・ 東京大学大学院工学系研究科国際工学教育推進機構 （東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 24 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results	We analyzed participants' characteristics, and built a prediction system on principle based traditional medicine pattern diagnosis.
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	Completed
Date of protocol fixation	2014 Year 08 Month 19 Day
Date of IRB
Anticipated trial start date	2014 Year 08 Month 19 Day
Last follow-up date	2018 Year 06 Month 13 Day
Date of closure to data entry	2018 Year 06 Month 13 Day
Date trial data considered complete	2018 Year 06 Month 13 Day
Date analysis concluded	2018 Year 06 Month 13 Day

Other

Other related information

Evidence-Based Complementary and Alternative Medicine Volume 2013, Article ID 398458, 8 pages http://dx.doi.org/10.1155/2013/398458 Evidence-Based Complementary and Alternative Medicine Volume 2014, Article ID 974139, 8 pages http://dx.doi.org/10.1155/2014/974139 Evidence-Based Complementary and Alternative Medicine Volume 2016, Article ID 3159617, 10 pages http://dx.doi.org/10.1155/2016/3159617 Evidence-Based Complementary and Alternative Medicine Volume 2014, Article ID 832824, 9 pages http://dx.doi.org/10.1155/2014/832824

Management information
Registered date	2015 Year 07 Month 24 Day
Last modified on	2022 Year 02 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021324