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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034512
Receipt No. 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 2018/10/16

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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
Middle name
Last name Sekiguchi Yuki
Organization Women's Clinic LUNA Next Stage
Division name Urology
Zip code
Address 132Bld.3F 1-32 Motomachi Naka-ku Yokohama-City
TEL 045-680-1226
Email dumbo-ys@d9.dion.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ninomiya Noriko
Organization Women's Clinic LUNA Shinsaibashi
Division name Urology
Zip code
Address 1-13-21 Nishishinsaibashi Chuoh-ku Osaka Japan
TEL 06-6251-7505
Homepage URL
Email ninomiya5829@yahoo.co.jp

Sponsor
Institute Women's Clinic LUNA Next Stage
Institute
Department

Funding Source
Organization Women's Clinic LUNA
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
Address
Tel
Email

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
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 Open public recruiting
Date of protocol fixation
2018 Year 06 Month 04 Day
Date of IRB
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
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 15 Day
Last modified on
2018 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039351

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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