UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054096 |
|---|---|
| Receipt number | R000061777 |
| Scientific Title | Clinical investigation of Kampo diagnostic support software compared with Kampo specialists |
| Date of disclosure of the study information | 2024/04/22 |
| Last modified on | 2025/04/10 09:09:44 |
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Basic information
Public title
Clinical investigation of Kampo diagnostic support software compared with Kampo specialists
Acronym
Comparison between Kampo diagnostic support software and specialists
Scientific Title
Clinical investigation of Kampo diagnostic support software compared with Kampo specialists
Scientific Title:Acronym
Comparison between Kampo diagnostic support software and specialists
Region
| Japan |
Condition
Condition
Every disease or disorder of adult outpatients in Kampo medicine
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Pneumology | Hematology and clinical oncology | Neurology |
| Psychosomatic Internal Medicine | Geriatrics | Obstetrics and Gynecology |
| Ophthalmology | Dermatology | Psychiatry |
| Oto-rhino-laryngology | Orthopedics | Urology |
| Oral surgery | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to investigate the accuracy, reliability, and future issues of Kampo diagnostic support software (KAMPO365) compared with specialists in Kampo medicine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We assess the concordance rate between the first Kampo formula candidate by KAMPO365 and specialists' diagnoses.
[Criteria of concordance between KAMPO365 and Kampo specialists]
1. The first Kampo formulas candidate output through KAMPO365 is included in 5 types of Kampo formulas selected by Kampo specialists.
2. The group of the first Kampo formulas candidate output through KAMPO365 matches that of a Kampo formula prescribed by Kampo specialists.
Key secondary outcomes
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. Patients with informed consent
2. New outpatients in Kampo medicine at our hospital or other collaborative research institute
3. >= 18 years old
4. Patients who can use a smartphone device or a tablet device
Key exclusion criteria
1. Patients who have already been taking any Kampo formulas
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazushi |
| Middle name | |
| Last name | Uneda |
Organization
Aizu Medical Center, Fukushima Medical University
Division name
Department of Kampo Medicine
Zip code
969-3492
Address
21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, Fukushima
TEL
+81-242-75-2100
uneda@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Kazushi |
| Middle name | |
| Last name | Uneda |
Organization
Aizu Medical Center, Fukushima Medical University
Division name
Department of Kampo Medicine
Zip code
969-3492
Address
21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, Fukushima
TEL
+81-242-75-2100
Homepage URL
uneda@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Kampo Medicine, Aizu Medical Center, Fukushima Medical University
Address
21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, Fukushima 969-3492, Japan
Tel
0242-75-2100
uneda@fmu.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
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
| 2024 | Year | 03 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None.
Management information
Registered date
| 2024 | Year | 04 | Month | 09 | Day |
Last modified on
| 2025 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061777
