Unique ID issued by UMIN | UMIN000032274 |
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Receipt number | 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 20:28:14 |
Verification of Wa-kan drug (Ryutanshakanto) for newly defined Chronic Pelvic Pain Syndrome (CPPS).
Verification of Ryutanshakanto for Chronic Pelvic Pain Syndrome.
Verification of Wa-kan drug (Ryutanshakanto) for newly defined Chronic Pelvic Pain Syndrome (CPPS).
Verification of Ryutanshakanto for Chronic Pelvic Pain Syndrome.
Japan |
Chronic pelvic pain syndrome
Urology |
Others
NO
Efficacy of Ryutanshakanto for Chronic Pelvic Pain Syndrome.
Efficacy
Exploratory
Pragmatic
Phase I,II
Evaluate improvement of symptom at 12 weeks with estimated symptom score (NIH-CPSI, CESI & ICSI/ICPI).
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.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
CPPS patients take Ryutanshakanto with 2.5 g per time
before each meal. Administration will be continued
for 84 days basically.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
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.
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.
30
1st name | |
Middle name | |
Last name | Keiichi Kondo |
Yokohama City University Hospital
Dept. of Urology
3-9 Fukuura, Kanazawa-ku, Yokohama
045-787-2679
kkurouro@yokohama-cu.ac.jp
1st name | |
Middle name | |
Last name | Keiichi Kondo |
Yokohama City University Hospital
Dept. of Urology
3-9 Fukuura, Kanazawa-ku, Yokohama
045-787-2679
kkurouro@yokohama-cu.ac.jp
Yokohama City University
Yokohama City University
Other
Yokohama City University Mecidal Center
Kinugasa Hospital
NO
2018 | Year | 04 | Month | 17 | Day |
Unpublished
Open public recruiting
2018 | Year | 03 | Month | 12 | Day |
2018 | Year | 03 | Month | 12 | Day |
2018 | Year | 04 | Month | 16 | Day |
2018 | Year | 04 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036802
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