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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046228
Receipt No. 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 2021/10/29

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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
Email 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
Email ch1644@yamada-bee.com

Sponsor
Institute Yamada Bee Company, Inc.
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2021 Year 10 Month 29 Day
Date of IRB
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
2021 Year 10 Month 29 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052379

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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