UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029113 |
|---|---|
| Receipt number | 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 09:49:33 |
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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
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
yamada@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
Center for Pharma-Food Research, Graduate School of Pharmaceutical Sciences, University of Shizuoka
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033293
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