UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062227 |
|---|---|
| Receipt number | R000071212 |
| Scientific Title | Exploratory pilot study on Hachimijiogan in prefrail andfrail older adults with nocturia |
| Date of disclosure of the study information | 2026/07/15 |
| Last modified on | 2026/07/13 22:44:30 |
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Basic information
Public title
A pilot study on the efficacy of Hachimijiogan for pre-frailty/frailty accompanied by nocturia
Acronym
Research on Hachimijiogan and Frailty
Scientific Title
Exploratory pilot study on Hachimijiogan in prefrail andfrail older adults with nocturia
Scientific Title:Acronym
Research on Hachimijiogan and Frailty
Region
| Japan |
Condition
Condition
pre-frailty/frailty
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the efficacy of Hachimijiogan in treating frailty and pre-frailty in patients who experience two or more nighttime urination episodes and have a JFS score of 4 or higher.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in the number of nighttime urination episodes from baseline (after 4 months)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Hachimijiogan
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
| 60 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients receiving treatment at Toyama University Hospital or Hida City Hospital
2) Men and women aged 60 or older but under 85 at the time of obtaining informed consent
3) Patients who have been taking any of the following oral medications for the past two months anticholinergics, beta 3 agonists, or alpha 1 blockers and who experience two or more episodes of nocturia
4) Japan Frailty Scale (JFS) score of 4 or higher
5) Patients capable of walking 5 meters or more
6) Patients who have provided written informed consent
Key exclusion criteria
1) Patients taking Japanese taraditional(Kampo) medicine
2) Patients who regularly consume health functional foods that may affect the study at least three times a week and are unable to discontinue their use starting three weeks before the start of the study
3) Patients who have changed the dosage or type of any of the following Western medications within the past two months, which may worsen frequent urination:no specific underlying medical conditions required
a) Diuretics
b) SGLT2 inhibitors
c) Cholinergic agents
d) PDE5 inhibitors
4) Patients with renal impairment (eGFR < 30 mL/min/1.73 m2)
5) Patients with severe hepatic impairment (AST or ALT >= 100 IU/L)
6) Patients with severely impaired walking ability, such as those who require a cane or wheelchair to walk
7) Patients with a sensitive gastrointestinal tract who are prone to diarrhea
8) Patients deemed unsuitable for participation in this study for other reasons, such as having serious complications
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | MOSABURO |
| Middle name | |
| Last name | KAINUMA |
Organization
University of Toyama
Division name
Deoartment of Japanese Oriental Medicine
Zip code
9300194
Address
2630 Sugitani Toyama
TEL
0764347393
kainuma@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Mosaburo |
| Middle name | |
| Last name | Kainuma |
Organization
University of Toyama
Division name
Department of Japanese Oriental Medicine
Zip code
930-0194
Address
2630 Sugitani Toyama
TEL
0764347393
Homepage URL
kainuma@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toayam
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Reserch Review Board, University of Toyama
Address
2630 Sugitani Toyama
Tel
076-415-8857
rinri@adm.u-toyama.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
| 2026 | Year | 07 | Month | 15 | 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 | 06 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 13 | Day |
Last modified on
| 2026 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071212
