UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034512 |
|---|---|
| Receipt number | R000039351 |
| Scientific Title | Study of the effect of goshajinkigan on pelvic floor muscle |
| Date of disclosure of the study information | 2018/10/15 |
| Last modified on | 2021/06/16 14:30:37 |
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Basic information
Public title
Study of the effect of goshajinkigan on pelvic floor muscle
Acronym
Pelvic floor muscle to 107 study
Scientific Title
Study of the effect of goshajinkigan on pelvic floor muscle
Scientific Title:Acronym
Pelvic floor muscle to 107 study
Region
| Japan |
Condition
Condition
Overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the effectiveness of goshajinkigan for patients with overactive bladder
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in questionnaire 3 months after administration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Only existing OAB therapeutic medicine Mirabegron will be administered within 3 months
Interventions/Control_2
In addition to Mirabegron
Medical extract formula Gosha-jinki-gan, 2.5 g once, 3 times a day, 3 months
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Pelvic floor muscle dysfunction patients
Key exclusion criteria
Residual urine volume after urination is 100 ml or more
Have severe heart disease, liver disease nor kidney disease
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Sekiguchi |
Organization
Women's Clinic LUNA Next Stage
Division name
Urology
Zip code
2310861
Address
132Bld.3F 1-32 Motomachi Naka-ku Yokohama-City
TEL
045-680-1226
dumbo-ys@d9.dion.ne.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Ninomiya |
Organization
Women's Clinic LUNA Shinsaibashi
Division name
Urology
Zip code
5420086
Address
1-13-21 Nishishinsaibashi Chuoh-ku Osaka Japan
TEL
06-6251-7505
Homepage URL
ninomiya5829@yahoo.co.jp
Sponsor or person
Institute
Women's Clinic LUNA Next Stage
Institute
Department
Personal name
Funding Source
Organization
Women's Clinic LUNA
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation LEADING GIRLS LUNA
Address
1-32 Motomachi Naka-ku Yokohama-City
Tel
045-680-1226
dumbo-ys@d9.dion.ne.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
L05-02
Org. issuing International ID_1
Medical Corporation LEADING GIRLS LUNA Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
no
Publication of results
Unpublished
Result
URL related to results and publications
no
Number of participants that the trial has enrolled
30
Results
Test canceled due to facility closure
Results date posted
| 2021 | Year | 06 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Women with overactive bladder symptoms
Participant flow
Randomly assign women with overactive bladder to the general overactive bladder medication and the group to receive additional Gosyajinkigan.
Adverse events
No serious side effects
Outcome measures
Grip strength test
Stride measurement
OABSS
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2018 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 15 | Day |
Last modified on
| 2021 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039351
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
