UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062952 |
|---|---|
| Receipt number | R000071998 |
| Scientific Title | Characterization of Kampo Medicine Use for Menopausal Symptoms: A Study Using Web-Based Surveys and Claims Databases |
| Date of disclosure of the study information | 2026/09/16 |
| Last modified on | 2026/09/16 14:44:19 |
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Basic information
Public title
Characterization of Kampo Medicine Use for Menopausal Symptoms: A Study Using Web-Based Surveys and Claims Databases
Acronym
Check-Me study
Scientific Title
Characterization of Kampo Medicine Use for Menopausal Symptoms: A Study Using Web-Based Surveys and Claims Databases
Scientific Title:Acronym
Check-Me study
Region
| Japan |
Condition
Condition
Menopausal Symptoms
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the symptom specific efficacy rates of Kampo medicines prescribed for menopausal disorders using data from Pep Up questionnaires, medical claim records ,hereinafter referred to as receipt data, and health checkups and to clarify which symptoms each prescription effectively addresses.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of efficacy rates by symptom and characteristics of each therapeutic agent
Key secondary outcomes
Patient characteristics of users of each therapeutic agent
Impact of each therapeutic agent on the degree of improvement in menopausal symptoms, productivity loss rate, and rate of impairment in daily activities
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
Individuals who are members of a health insurance association during the period from October 1, 2026, to December 31, 2026.
Individuals who indicated that they had experienced menopausal symptoms within the past six months in the Pep Up questionnaire.
Individuals with a diagnosis of a condition associated with menopausal symptoms in medical claim data from the past six months, and who were prescribed Kampo medicine, HRT, or psychotropic medication within the same claim.
Key exclusion criteria
The following groups are defined as the target populations in accordance with the research proposal.
Prescriptions for two or more agents from the categories of Kampo medicines, HRT, and psychotropic drugs are present in medical claim data from the past six months. However, for HRT, the prescription of two or more agents within the same category is permitted; for psychotropic drugs, the prescription of two or more agents within the respective therapeutic classes of hypnotics/sedatives, anxiolytics, antidepressants, and mood stabilizers is permitted.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Matsuo |
Organization
Kracie, Ltd.
Division name
Pharmaceutical Research Promotion Department,Pharmaceutical Division, Pharmaceutical Company
Zip code
108-8080
Address
3-20-20, Kaigan, Minato-ku, Tokyo, Japan
TEL
03-5446-3352
matsuo_takeshi@kracie.co.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Matsuo |
Organization
Kracie, Ltd.
Division name
Pharmaceutical Research Promotion Department,Pharmaceutical Division, Pharmaceutical Company
Zip code
108-8080
Address
3-20-20, Kaigan, Minato-ku, Tokyo, Japan
TEL
03-5446-3352
Homepage URL
matsuo_takeshi@kracie.co.jp
Sponsor or person
Institute
Kracie, Ltd.
Institute
Department
Personal name
Takeshi Matsuo
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
JMDC Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoyukai RiverSide Clinic
Address
2-1 west, 7 South, Chuo-ku, Sapporo, Hokkaido
Tel
011-521-2321
rinrishinsa@riversideclinic.or.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
| 2026 | Year | 09 | Month | 16 | 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
| 2026 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A Cohort Study Using the Web Survey and the JMDC Database
Management information
Registered date
| 2026 | Year | 09 | Month | 16 | Day |
Last modified on
| 2026 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071998
