Patients with interstitial cystitis
Conditions
Interventions
Ingestion of test food including fermented buckwheat sprouts (12 weeks, 4 tablets / once a day)
Sponsors
Center for Pharma-Food Research, Graduate School of Pharmaceutical Sciences, University of Shizuoka
Kageyama Hospital (Shizuoka city) Nakamura Hospital (Beppu city)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with interstitial cystitis who exert either pollakiuria, acceleration of urinary desire or urinary urgency in addition to bladder pain 2) Patients who have received confirmed diagnosis of interstitial cystitis by the cystoscopy or hydrostatic dilator in the past. 3) Patients who are not satisfied by the current treatment
Exclusion criteria
Exclusion criteria: 1) Patients with a previous history of urinary tract and genital infection within the past 3 months (excluding asymptomatic pyuria). 2) Patients within 3 months after hydrostatic dilator. 3) Patients with an interstitial cystitis symptom score of less than 9 ( a perfect score of 20) and satisfying the current treatment at more than 50 scores of VAS 4) Patients who have taken in fermented buckwheat sprouts within the past 3 months 5) Patients whose major cause of current symptoms (having bladder pain and frequent urination, urinary acceleration or urinary urgency) may be considered as other diseases (overactive bladder, neurogenic bladder, prostatic hyperplasia etc.) 6) The subjects who have allergy symptoms by buckwheat (test ingredients) 7) The subjects who are judged to be inappropriate by the responsible doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes are clinical questionnaire test (subjective symptom for OABSS, IPSS, bother OABSS,et) and maximal urine before and after repeated oral intake (12 weeks) of fermented buckwheat sprouts | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary outcomes are the following examinations: 1)height, body weight 2)Questionnaire for subjective symptoms for overactive bladder, prostatic hyperplasia, lower urinary tract symptoms and interstitial cystitis, and urination 3)physical examination 4)hematology test 5)quantitative measurements of various clinical biomarkers in the blood and urine. | — |
Countries
Japan
Contacts
Public ContactShizuo Yamada
University of Shizuoka Center for Pharma-Food Research, Graduate School of Pharmaceutical Sciences
Outcome results
None listed