UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041895 |
|---|---|
| Receipt number | R000047819 |
| Scientific Title | Examination of the effect of test food intake on pollakiuria in women |
| Date of disclosure of the study information | 2021/12/14 |
| Last modified on | 2021/03/31 15:20:36 |
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Basic information
Public title
Examination of the effect of test food intake on pollakiuria in women
Acronym
Examination of the effect of test food intake on pollakiuria in women
Scientific Title
Examination of the effect of test food intake on pollakiuria in women
Scientific Title:Acronym
Examination of the effect of test food intake on pollakiuria in women
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of test food intake for 8 consecutive weeks on pollakiuria
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
OAB-q and Bladder diary before and after 4 weeks and 8 weeks, and OABSS before and after 8 weeks
Key secondary outcomes
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
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food once a day for 8 weeks
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
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
1)Healthy females from 20 to 79 years of age
2)Daytime urinary frequency is more than 8 times
Key exclusion criteria
1) Subjects who have urinary urgency score >= 2, and total score >= 3 in OABSS
2) Subjects who are LUTS/OAB patients or need to treatment of disease
3) Subjects who routinely use dietary supplements and medicines containing the ingredients involved in the test food
4) Subjects who routinely use dietary supplements and medicines that are said to be effective for pollakiuria
5) Subjects who have a urinary calculus or a history of such diseases
6) Subjects who have a disease requiring regular medication or a history of serious diseases for which medication was required
7) Subjects who have a disease requiring treatment or a history of serious diseases
8) Subjects who have possibilities for emerging allergy related to the study
9) Subjects who drink much alcohol
10) Subjects who cannot follow the procedures of various tests to be carried out during this study
11) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
12) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
13) Subjects who are pregnant or breastfeeding and who are going to become pregnant or breastfeed during the study period
14) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
15) Subjects who are judged as unsuitable for the study by the investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Hokari |
Organization
Maruhachi Muramatsu, Inc.
Division name
Development Research Center Research group
Zip code
425-0065
Address
1355, Souemon, Yaizu, Shizuoka
TEL
054-624-5440
yoshinori.hokari@08m.co.jp
Public contact
Name of contact person
| 1st name | Kotoha |
| Middle name | |
| Last name | Isobe |
Organization
TTC Co., Ltd.
Division name
Clinical Research Planning Department
Zip code
150-0021
Address
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
k.isobe@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
non-disclosure
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
t.saito@ttc-smo.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 14 | 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
| 2020 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 25 | Day |
Last modified on
| 2021 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047819
