Clinical study on the effect of fermented buckwheat sprouts in patients with interstitial cystitis

Not Applicable

• Conditions: Patients with interstitial cystitis

• Registration Number: JPRN-UMIN000029113
• Lead Sponsor: Center for Pharma-Food Research, Graduate School of Pharmaceutical Sciences, University of Shizuoka

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-20
• Study Completion: 2018-05-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.