UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057097 |
|---|---|
| Receipt number | R000064710 |
| Scientific Title | Evaluation of Treatment Outcomes of Patients Visiting Kampo Outpatient Clinics Using an Electronic Questionnaire |
| Date of disclosure of the study information | 2025/02/20 |
| Last modified on | 2025/08/21 09:55:04 |
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Basic information
Public title
Evaluation of Treatment Outcomes of Patients Visiting Kampo Outpatient Clinics Using an Electronic Questionnaire
Acronym
Evaluation of Treatment Outcomes of Patients Visiting Kampo Outpatient Clinics Using an Electronic Questionnaire
Scientific Title
Evaluation of Treatment Outcomes of Patients Visiting Kampo Outpatient Clinics Using an Electronic Questionnaire
Scientific Title:Acronym
Evaluation of Treatment Outcomes of Patients Visiting Kampo Outpatient Clinics Using an Electronic Questionnaire
Region
| Japan |
Condition
Condition
Registry study in which all patients visiting a kampo outpatient clinic can be included, with no restrictions based on disease
Classification by specialty
| Medicine in general | Obstetrics and Gynecology | Dermatology |
| Psychiatry | Oto-rhino-laryngology | Orthopedics |
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will search for factors that influence the diagnosis of Kampo medicine, the selection of Kampo medicine, and the prognosis of treatment in patients treated with Kampo medicine by accumulating data from multiple institutions, and improve the algorithm for predicting Sho from the input of medical questionnaires, as well as for predicting changes in Kampo medicine prescribed by doctors and subjective complaints after oral administration of Kampo medicine. The purpose of this study is to create an algorithm to predict changes in subjective complaints after taking Kampo medicine and Kampo medicine prescribed by doctors.
Basic objectives2
Others
Basic objectives -Others
By accumulating data from multiple institutions, this study clarified factors that influence the diagnosis, selection, and prognosis of Kampo medicine in patients treated with Kampo medicine, and improved the algorithm for predicting Sho from the input of medical questionnaires, as well as the algorithm for predicting changes in Kampo medicine prescribed by physicians and subjective complaints after oral administration of Kampo medicine. We will also create an algorithm for predicting changes in subjective complaints after doctors prescribe Kampo medicine and Kampo medicine is taken, and develop a medical care support system for the appropriate use of Kampo medicine. This is expected to enable the provision of efficient and safe medical care in the medical field.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in chief complaint VAS values after outpatient visit
Key secondary outcomes
Creation of a prediction equation to predict changes in chief complaint VAS, Kampo diagnosis, and Kampo prescriptions based on the input results of the initial medical interview and survey items.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Adult patients who visited the outpatient clinic for Kampo medicine at the research institution during the period under study
2. Patients who used the electronic medical questionnaire
3. Patients who have given appropriate consent
Key exclusion criteria
Patients whom the investigator determines should be excluded
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Tetsuhiro |
| Middle name | |
| Last name | Yoshino |
Organization
Keio University
Division name
Holistic Kampo Diagnosis Lab.
Zip code
1608582
Address
35 Shinanomachi, Shinjuku, Tokyo, JAPAN
TEL
03-5366-3824
keiokampo@gmail.com
Public contact
Name of contact person
| 1st name | Tetsuhiro |
| Middle name | |
| Last name | Yoshino |
Organization
Keio University
Division name
Holistic Kampo Diagnosis Lab.
Zip code
1608582
Address
35 Shinanomachi, Shinjuku, Tokyo, JAPAN
TEL
03-5366-3824
Homepage URL
keiokampo@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
TSUMURA & CO.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku, Tokyo, JAPAN
Tel
03-5363-3638
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
慶應義塾大学病院（東京都）、東京大学（東京都）、東北大学病院（宮城県）、東海大学（神奈川県）、北里大学北里研究所病院（東京都）、福島県立医科大学（福島県）、京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2032 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2032 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2032 | Year | 03 | Month | 31 | Day |
Other
Other related information
In addition to evaluating changes in the chief complaint VAS after an outpatient visit, we will attempt to develop a prediction equation to predict changes in the chief complaint VAS, Kampo diagnosis, and Kampo prescription by referring to the results of the patient's input into the electronic medical questionnaire used to prepare medical records, the Kampo medical findings, Kampo diagnosis, Western medical diagnosis, and prescription drugs, and the free medical history, history of illness, complications, concomitant medications, blood test and urine analysis in the medical record. The study will attempt to create a prediction equation to predict changes in the chief complaint VAS, Kampo diagnosis, and Kampo prescriptions.
Management information
Registered date
| 2025 | Year | 02 | Month | 20 | Day |
Last modified on
| 2025 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064710
