UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051297 |
|---|---|
| Receipt number | R000058509 |
| Scientific Title | Study of the effect of intake of test supplement on urinary voiding in women: A randomized, double blind, placebo-controlled, and parallel group comparison study |
| Date of disclosure of the study information | 2023/06/09 |
| Last modified on | 2024/04/16 13:56:57 |
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Basic information
Public title
Study of the effect of intake of test supplement on urinary voiding in women: A randomized, double blind, placebo-controlled, and parallel group comparison study
Acronym
Study of the effect of intake of test supplement on urinary voiding in women
Scientific Title
Study of the effect of intake of test supplement on urinary voiding in women: A randomized, double blind, placebo-controlled, and parallel group comparison study
Scientific Title:Acronym
Study of the effect of intake of test supplement on urinary voiding in women
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy on urinary voiding and safety of intake of test supplement for 8 consecutive weeks, using placebo as a control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Bladder diary (urinary frequency, urine volume)
Key secondary outcomes
OAB-q, OABSS-Bother, IPSS-Bother, Pittsburgh sleep quality index-Japanese version (PSQI-J)
Subgroup analysis of primary and secondary outcome based on urinary frequency, nocturia, or PSQI-J
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test supplement for 8 consecutive weeks
Interventions/Control_2
Intake of placebo for 8 consecutive weeks
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. Japanese female from 20 to 80 years of age
2. Subjects who have problems with urinary voiding (urinary frequency more than 8 times during the day)
Key exclusion criteria
1. Subjects who are judged to have overactive bladder
2. Subjects who have nocturia more than twice in the bladder diary at the time of the pre-test
3. Subjects who are undergoing hospitalization/treatment for dysuria, or those who have been judged to require treatments
4. Subjects who are unable to measure or record the urine volume for a designated period
5. Subjects who have urinary tract infection, urinary tract stones, kidney stones, ureteral stones, gallstones, etc.
6. Subjects who are taking health foods that affect urination at least once a week
7. Subjects who are currently taking medication or exercise therapy
8. Subjects who have or have a history diseases such as diabetes, hepatic, renal, cardiac diseases, diseases that affect the secretion of adrenal cortical hormones, or other metabolic diseases
9. Subjects who have a disease that requires constant medication, those who have a disease under treatment, those who have a history of serious disease that required medication
10. Subjects who may develop allergies in relation to the study
11. Subjects who have participated in other clinical trials within the past month prior to the pre-test date
12. Subjects who have had abnormalities in clinical test values or cardiopulmonary function, and are judged to have a problem participating in the study
13. Subjects whose physical measurements, physical examination values, and clinical test values before the start of intake were significantly out of the reference range
14. Subjects who work in shifts, work late at night, etc., and have an irregular daily rhythm
15. Subjects who are judged to be unsuitable as subjects based on the answers to the background survey.
16. Subjects who plan to become pregnant or breastfeed during the study period
17. Subjects who are judged to be unsuitable as subjects by the principal investigator or the principle investigational doctor
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Matsuoka |
| Middle name | |
| Last name | Sayuri |
Organization
FANCL Corporation
Division name
Research Institute, Health science research center
Zip code
244-0806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3449
matsuoka@fancl.co.jp
Public contact
Name of contact person
| 1st name | Bansho |
| Middle name | |
| Last name | Yoshimi |
Organization
EP Mediate Co., Ltd.
Division name
R&D Support Center Foods Department Trial Planning Section 1
Zip code
162-0821
Address
Kagurazaka AK Bldg., 1-8 Tsukudocho, Shinjuku-ku, Tokyo
TEL
070-3023-8209
Homepage URL
bansho.yoshimi189@eps.co.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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, Meguro-ku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@eps.co.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
| 2023 | Year | 06 | Month | 09 | 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
60
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
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 08 | Day |
Last modified on
| 2024 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058509
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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