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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019333
Receipt No. R000022357
Scientific Title Effect of Ao-dake-humi on lower urinary tract symptoms, constipation, and hie-shou
Date of disclosure of the study information 2015/10/15
Last modified on 2017/04/14

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Basic information
Public title Effect of Ao-dake-humi on lower urinary tract symptoms, constipation, and hie-shou
Acronym Ao-dake-humi on LUTS
Scientific Title Effect of Ao-dake-humi on lower urinary tract symptoms, constipation, and hie-shou
Scientific Title:Acronym Ao-dake-humi on LUTS
Region
Japan

Condition
Condition Lower urinary tract symptoms
Constipation
Hiesyou
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficasy and safety of Ao-dake-humi on LUTS, constipation, and hie-syo
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes International porsotate symptom score
Overactive bladder symptom score
Visual analogue schale on constipation and hie-shou
Before and after aodakehumi(28 days)
Key secondary outcomes Flow volume chart 3days
observation with thirmography
Before and after aodakehumi(28 days)

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
Device,equipment
Interventions/Control_1 Daily practice of Aodakehumi for 28 days
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who have LUTS, constipation, or hiesyou
Key exclusion criteria Patients who put on Helthy sunddal everyday
Patiens who cannot walk by theirselves without steck
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomonori MINAGAWA
Organization Shinshu University
Division name Department of Urology
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL +81263372661
Email minagawat@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomonori MINAGAWA
Organization Shinshu University
Division name Department of Urology
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL +81263372661
Homepage URL
Email minagawat@shinshu-u.ac.jp

Sponsor
Institute Shinshu university
Institute
Department

Funding Source
Organization Shinshu university
Organization
Division
Category of Funding Organization Other
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 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
2015 Year 10 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2014 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 10 Month 13 Day
Last modified on
2017 Year 04 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022357

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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