UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study on the effect of fermented buckwheat sprouts in patients with interstitial cystitis
Acronym	Clinical study on the effect of fermented buckwheat sprouts in patients with interstitial cystitis
Scientific Title	Clinical study on the effect of fermented buckwheat sprouts in patients with interstitial cystitis
Scientific Title:Acronym	Clinical study on the effect of fermented buckwheat sprouts in patients with interstitial cystitis
Region	Japan

Condition
Condition	Patients with interstitial cystitis
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study beneficial effect of fermented buckwheat sprouts on patients with interstitial cystitis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	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
Key secondary outcomes	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.

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	NO
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Ingestion of test food including fermented buckwheat sprouts (12 weeks, 4 tablets / once a day)
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	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
Key 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.
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Shizuo Middle name Last name Yamada
Organization	University of Shizuoka
Division name	Center for Pharma-Food Research, Graduate School of Pharmaceutical Sciences
Zip code	422-8526
Address	52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL	054-264-5625
Email	yamada@u-shizuoka-ken.ac.jp

Public contact
1st name of contact person	1st name Shizuo Middle name Last name Yamada
Organization	University of Shizuoka
Division name	Center for Pharma-Food Research, Graduate School of Pharmaceutical Sciences
Zip code	422-8526
Address	52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL	054-264-5625
Homepage URL
Email	yamada@u-shizuoka-ken.ac.jp

Sponsor
Institute	Center for Pharma-Food Research, Graduate School of Pharmaceutical Sciences, University of Shizuoka
Institute
Department

Funding Source
Organization	Fujikogei Co. Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Kageyama Hospital (Shizuoka city) Nakamura Hospital (Beppu city)
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Center for Pharma-Food Research, Graduate School of Pharmaceutical Sciences, University of Shizuoka
Address	52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
Tel	054-264-5625
Email	yamada@u-shizuoka-ken.ac.jp

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	静岡県立大学　薬食生命科学総合学府　薬学研究院　薬食研究推進センター

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 20 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	Completed
Date of protocol fixation	2017 Year 08 Month 18 Day
Date of IRB	2017 Year 08 Month 18 Day
Anticipated trial start date	2017 Year 10 Month 10 Day
Last follow-up date	2018 Year 05 Month 07 Day
Date of closure to data entry	2018 Year 05 Month 15 Day
Date trial data considered complete	2018 Year 05 Month 15 Day
Date analysis concluded	2018 Year 05 Month 28 Day

Other
Other related information

Management information
Registered date	2017 Year 09 Month 12 Day
Last modified on	2019 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033293