UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058774 |
|---|---|
| Receipt number | R000067203 |
| Scientific Title | An open-label, multicenter, prospective registration study on the efficacy and safety of Goshajinkigan for nocturia |
| Date of disclosure of the study information | 2025/08/15 |
| Last modified on | 2025/08/12 19:22:01 |
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Basic information
Public title
Clinical study on the effect of Goshajinkigan for nocturia
Acronym
Effect of Goshajinkigan for nocturia
Scientific Title
An open-label, multicenter, prospective registration study on the efficacy and safety of Goshajinkigan for nocturia
Scientific Title:Acronym
Effect of Goshajinkigan for nocturia
Region
| Japan |
Condition
Condition
Nocturia more than twice a night
Classification by specialty
| Geriatrics | Urology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The subjects are patients aged 65 years or older with nocturia who are resistant to alpha-blockers, anticholinergics, and beta 3 agonists and wake up more than twice a night. Goshajinkigan will be administered for 12 weeks to patients with Jin-kyo, and its clinical effects will be examined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Comparison of nocturnal urinary frequency (average of voiding diary for 3 days) before and after 12 weeks of treatment
Key secondary outcomes
1) Comparison of PSQI (Pittsburgh Sleep Quality Index), IPSS (International Prostate Symptom Score), IPSS-QOL, and OABSS (Overactive Bladder Symptom Score) before and after 12 weeks of treatment, 2) Comparison of modified nocturnal polyuria index (mNPI, which is corrected assuming NPI is 8 hours) before and after 12 weeks of treatment.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Goshajinkigan (Tsumura Co., Ltd.). 2.5g twice a day, before breakfast and dinner (can be taken after meals if stomach discomfort occurs). The
period of administration is 12 weeks or more if possible. The patient is responsible for the cost of the medication.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Elderly patients aged 65 or older with nocturia (including benign prostatic hyperplasia [BPH] and overactive bladder [OAB]) who awaken twice or more during the night. The severity of BPH/OAB is not important (including mild cases with an IPSS score of 0-7).
2) Patients with dissatisfaction with an IPSS-QOL score of 3 or higher (mixed about equally satisfied and dissatisfied regarding the continuation of their current urinary condition).
3) Patients with Jin-kyo (fatigue and lethargy are easily recognized, weakness and chills in the lower body, decreased or frequent urination, and sometimes dry mouth) and with weakness of the lower abdominal region (Jin-kyo score of 13 or higher).
4) Regardless of the presence or absence of sleep disorders or testosterone deficiency.
Key exclusion criteria
1) Patients who discontinued, started, or changed the dosage of urinary dysfunction medication within the past month.
2) Patients who discontinued or started antiandrogens (including 5alpha reductase inhibitors) within the past six months (men).
3) Patients who changed the dosage of medications that may affect urination during the study period (antihypertensives, hypnotics, erectile dysfunction
medications [for men], diuretics, antidiuretic hormone preparations, etc.).
4) Patients who spent long periods of time in bed during the day (patients who were generally active during their daily lives were generally included).
5) Patients with untreated organic diseases of the lower urinary tract (benign prostatic hyperplasia, prostate cancer, bladder neck contracture, urethral
stricture, bladder tumors, bladder stones, etc.) or active urinary tract infections (bacterial cystitis, bacterial prostatitis, etc.).(This is an option for
patients with treatment-resistant chronic urinary tract infections without subjective symptoms or obvious signs of infection, but it is preferable to avoid
it if possible.)
6) Patients with clinically significant signs of heart failure (symptoms due to exercise, apparent increased CTR, NT-proBNP >= 300 pg/ml).
7) Patients with no desire to urinate or postvoid residual urine volume of 100 ml or more.
8) Other cases in which the attending physician judges enrollment in this study to be inappropriate.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Oh-oka |
Organization
Independent administrative agency, National Hospital Organization, Kobe Medical Center
Division name
Department of Urology
Zip code
6580032
Address
3-1-11, Nishiochiai, Suma-ku, Kobe-shi, Hyogo, 654-0155
TEL
+81-78-791-0111
bigokamarie2025@ares.eonet.ne.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Oh-oka |
Organization
Independent administrative agency, National Hospital Organization, Kobe Medical Center
Division name
Department of Urology
Zip code
6540155
Address
3-1-1, Nishiochiai, Suma-ku, Kobe-shi, Hyogo
TEL
+81-78-791-0111
Homepage URL
https://hinyouki-kampo.net/gakujutsu/
bigokamarie2025@ares.eonet.ne.jp
Sponsor or person
Institute
Urological Kampo Research Society
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
Ethics Committee of the National Hospital Organization Kobe Medical Center
Address
Nishiochiai, Suma-ku, Kobe-shi, Hyogo
Tel
+81-78-791-0111
412-kanrika@mail.hosp.go.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
神戸医療センター（兵庫県）、三重大学病院（三重県）、女性医療クリニック LUNA グループ（神奈川県）、滋賀医科大学（滋賀県）、ベルランド総合病院（大阪府）、静岡県立総合病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 15 | Day |
Related information
URL releasing protocol
https://hinyouki-kampo.net/gakujutsu/
Publication of results
Unpublished
Result
URL related to results and publications
https://hinyouki-kampo.net/gakujutsu/
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 | 06 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 08 | 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
| 2025 | Year | 08 | Month | 12 | Day |
Last modified on
| 2025 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067203
