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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029113
Receipt No. R000033293
Scientific Title Clinical study on the effect of fermented buckwheat sprouts in patients with interstitial cystitis
Date of disclosure of the study information 2017/09/20
Last modified on 2019/03/17

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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
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
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

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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