UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059796 |
|---|---|
| Receipt number | R000068008 |
| Scientific Title | A Cross-sectional Study on the Duration of Gardenia jasminoides (Sanshishi)-containing Kampo Extract Use and Related Background Factors among Outpatients at Our Institution |
| Date of disclosure of the study information | 2025/11/17 |
| Last modified on | 2025/11/16 21:18:22 |
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Basic information
Public title
A Cross-sectional Study on the Duration of Gardenia jasminoides (Sanshishi)-containing Kampo Extract Use and Related Background Factors among Outpatients at Our Institution
Acronym
A Cross-sectional Study on the Duration of Gardenia jasminoides (Sanshishi)-containing Kampo Extract Use and Related Background Factors among Outpatients at Our Institution
Scientific Title
A Cross-sectional Study on the Duration of Gardenia jasminoides (Sanshishi)-containing Kampo Extract Use and Related Background Factors among Outpatients at Our Institution
Scientific Title:Acronym
A Cross-sectional Study on the Duration of Gardenia jasminoides (Sanshishi)-containing Kampo Extract Use and Related Background Factors among Outpatients at Our Institution
Region
| Japan |
Condition
Condition
Diseases generally indicated for Kampo extract preparations containing Gardenia jasminoides (Sanshishi)
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify a part of the real-world prescription status of Kampo extract preparations containing Gardenia jasminoides (Sanshishi) by conducting a cross-sectional survey on the duration of use of Gardenia-containing Kampo formulations among patients prescribed Kampo extract preparations.
Basic objectives2
Others
Basic objectives -Others
epidemiological survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of patients prescribed Gardenia-containing Kampo extract preparations among all patients who were prescribed Kampo formulations during the data collection period, the breakdown of Gardenia-containing Kampo preparations, and the estimated cumulative dose of Gardenia jasminoides (Sanshishi).
Key secondary outcomes
Patient background (department, current medical history, and past medical history) of patients prescribed Gardenia-containing Kampo extract preparations among all patients who were prescribed Kampo formulations during the data collection period.
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 visited Shinshu University Hospital between April 1, 2017, and March 31, 2025, and were prescribed Kampo extract preparations in the outpatient clinic.
Key exclusion criteria
None.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | KUNIHIRO |
| Middle name | |
| Last name | MITSUZAWA |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
390-8621
Address
3-1-1, Asahi Matsumoto, Nagano
TEL
0263-37-2670
mitsukuni@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | KUNIHIRO |
| Middle name | |
| Last name | MITSUZAWA |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
390-8621
Address
3-1-1, Asahi Matsumoto, Nagano
TEL
0263372670
Homepage URL
mitsukuni@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University School of Medicine Ethics Committee for Research in Life Sciences and Medicine
Address
3-1-1 Asahi, Matsumoto City, Nagano
Tel
0263-37-3099
mdrinri@shinshu-u.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
| 2025 | Year | 11 | Month | 17 | 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
| 2025 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 17 | 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
Patients who were prescribed herbal extracts containing sanshishi (gardenia zi) will be extracted from medical records, and the type of herbal medicine containing gardenia zi and the duration of administration will be investigated from prescription and medical records. Furthermore, the cumulative dose of gardenia zi will be estimated from the prescription records, and cases with a cumulative dose of 5000g or more will be extracted to examine their background factors.
Management information
Registered date
| 2025 | Year | 11 | Month | 16 | Day |
Last modified on
| 2025 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068008
