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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032274
Receipt No. R000036802
Scientific Title Verification of Wa-kan drug (Ryutanshakanto) for newly defined Chronic Pelvic Pain Syndrome (CPPS).
Date of disclosure of the study information 2018/04/17
Last modified on 2018/04/16

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Basic information
Public title Verification of Wa-kan drug (Ryutanshakanto) for newly defined Chronic Pelvic Pain Syndrome (CPPS).
Acronym Verification of Ryutanshakanto for Chronic Pelvic Pain Syndrome.
Scientific Title Verification of Wa-kan drug (Ryutanshakanto) for newly defined Chronic Pelvic Pain Syndrome (CPPS).
Scientific Title:Acronym Verification of Ryutanshakanto for Chronic Pelvic Pain Syndrome.
Region
Japan

Condition
Condition Chronic pelvic pain syndrome
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy of Ryutanshakanto for Chronic Pelvic Pain Syndrome.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Evaluate improvement of symptom at 12 weeks with estimated symptom score (NIH-CPSI, CESI & ICSI/ICPI).
Key secondary outcomes Evaluate improvement of symptom at 2 weeks with estimated symptom score, NIHCPSI, CESI & ICSI/ICPI.
Evaluate improvement of urine flow rate & residual urine at 12 weeks.
Evaluate safety and sustainability of Ryutanshakanto.

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 CPPS patients take Ryutanshakanto with 2.5 g per time
before each meal. Administration will be continued
for 84 days basically.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients who has pelvic pain continuously for more than 3 months.
Patients who do not show bacteriuria at registration.
Patients who have never taken medicine for CPPS or did not take same medicine more than 3 month until registration.
Patients who can response for questionnaire and examination.
Key exclusion criteria Patients who have acute bacterial prostatitis.
Patients who have severe risk for urinary retention.
Patients who show abnormal PSA or abnormality of urine cytology.
Patients who have pneumonitis.
Patients who have moderate ~ severe liver dysfunction.
Patients who have aldosteronism.
Patients who show low serum potassium.
Patients who have myopathy.
Patients who are judged as unfitness by physician.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiichi Kondo
Organization Yokohama City University Hospital
Division name Dept. of Urology
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama
TEL 045-787-2679
Email kkurouro@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiichi Kondo
Organization Yokohama City University Hospital
Division name Dept. of Urology
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama
TEL 045-787-2679
Homepage URL
Email kkurouro@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization Yokohama City University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Yokohama City University Mecidal Center
Kinugasa Hospital
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
2018 Year 04 Month 17 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 03 Month 12 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 12 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
2018 Year 04 Month 16 Day
Last modified on
2018 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036802

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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