UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046228 |
|---|---|
| Receipt number | R000052379 |
| Scientific Title | A study of the effect of improving urinary problems with foods containing Brazilian green propolis extract, pumpkin seed extract and cranberry extract in healthy women |
| Date of disclosure of the study information | 2021/11/30 |
| Last modified on | 2022/09/27 17:02:34 |
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Basic information
Public title
A study of the effect of improving urinary problems with foods containing Brazilian green propolis extract, pumpkin seed extract and cranberry extract in healthy women
Acronym
A study of the effect of improving urination problems by ingesting functional foods
Scientific Title
A study of the effect of improving urinary problems with foods containing Brazilian green propolis extract, pumpkin seed extract and cranberry extract in healthy women
Scientific Title:Acronym
A study of the effect of improving urination problems by ingesting functional foods
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of test food intake on urinary symptoms in Japanese women who are aware of and suffer from frequent urination.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of nocturnal urination
Key secondary outcomes
Bladder diary
Questionnaire for urination and sleeping
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
functional food
Intake: 810 mg
Ingesion: 56 day
Interventions/Control_2
Placebo food
Intake: 810 mg
Ingesion: 56 day
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
1. Healthy Japanese men and women aged more than 40 years, less than 80 years at the time of giving informed consent.
2. Individuals who are aware of frequent urination, who are suffering from frequent urination.
3. Individuals who urinate more than once at night.
4. Individuals who has freely given consent and has understood the purpose of the study.
5. BMI:18.5 - 30.0
6. Individuals who are considered fit for the enrollment in the clinical study.
Key exclusion criteria
1. Individuals who undergoing treatment for urinary disorders such as overactive bladder, bladder inflammation, and urethral stones.
2. Individuals whose OABSS score is over 2 point in the Q. 3 and over 3 points in the total score of the OABSS.
3. Individuals with a current history of diabetes, cerebrovascular accidents, sequelae of stroke, spinal cord disorders, spinal degenerative disorders, sleep disorders, mental disorder and hypertension.
4. Individuals who have a disorder to absorption, distribution, metabolism, excretion of food, such as digestive tract, liver, kidney, heart and cardiovascular system.
5. Individuals with a history of the surgery considerable in the gastrointestinal tract site, for example, gastrectomy, stomach and intestines suturation, intestinal tract resection and so on (Excluding polypectomy and appendectomy).
6. Individuals with current or history of uterine fibroids, endometriosis, or pelvic organ prolapse.
7. Individuals with a history of uterine or pelvic surgery.
8. Individuals who are receiving hormone replacement therapy (estrogen, progesterone preparations (drinks, patches, ointments), etc.), those who plan to take it during the study period.
9. Individuals who regularly overdose beverages containing diuretic ingredients.
10. Individuals with a history of allergies or asthma.
11. Individuals who regularly take health foods, supplements, and medicines that may affect the test.
12. Be Suspected alcohol or drug dependence.
13. Individuals who have smoked since 3 months of consent.
14. Individuals who participated in other clinical trial at resent (past 84 days).
15. Individuals with irregular lifestyles due to night shifts or shift work.
16. Individuals who live with or will participate in this test.
17. Individuals who cannot comply with the management items during this test.
18. Individuals who work for health food, cosmetics, pharmaceutical companies.
19. Individuals judged inappropriate for the study by the principal.
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | Yuzuri |
| Middle name | |
| Last name | Sato |
Organization
Higashikoganei Sakura Clinic
Division name
Not applicable
Zip code
184-0011
Address
4-37-26 Higashi-cho, koganei-si, Tokyo 184-0011 Japan
TEL
042-382-3081
tsurumaki-jua@umin.ac.jp
Public contact
Name of contact person
| 1st name | Chizuru |
| Middle name | |
| Last name | Fujikura |
Organization
Yamada Bee Company, Inc.
Division name
Functional research section, Institute for Bee Products & Health Science, R&D department
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL
0868-54-3825
Homepage URL
ch1644@yamada-bee.com
Sponsor or person
Institute
Yamada Bee Company, Inc.
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Research Center for Immunological Analysis, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
seishukai Clinic Ethics Committee
Address
3-18-5 matsugaya, taitou-ku, Tokyo 111-0036 Japan
Tel
03-5827-0930
t-takahama@seishukai.or.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 | 11 | Month | 30 | 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
| 2021 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 30 | Day |
Last modified on
| 2022 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052379
