UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039302 |
|---|---|
| Receipt number | R000044826 |
| Scientific Title | Effect of functional food on the improvement for male sexual function |
| Date of disclosure of the study information | 2021/05/31 |
| Last modified on | 2021/03/11 09:44:18 |
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Basic information
Public title
Effect of functional food on the improvement for male sexual function
Acronym
Effect of functional food on the improvement for male sexual function
Scientific Title
Effect of functional food on the improvement for male sexual function
Scientific Title:Acronym
Effect of functional food on the improvement for male sexual function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the effect of functional food on the improvement for male sexual function, and the safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IIEF15
Key secondary outcomes
Various questionnaires
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
Ingestion of functional food for 12 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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
1. Japanese men aged greater than or equal to 30 years, less than 80 years at the time of obtaining informed consent.
2. Subjects with IIEF-EF domain score of 11 to 21 at screening.
3. Subjects with AMS score of 27 to 49 at screening.
4. Subjects who have attempted heterosexual intercourse at least once every 4 weeks.
5. Subjects who got adequate explanation about the purpose and details of the examination, have the capacity to consent, voluntarily participate in understanding, and agree to participate in the examination in writing.
Key exclusion criteria
1. Subjects who have received ED treatment or infertility treatment.
2. Subjects who have past or current medical history related to urology such as prostatic hypertrophy.
3. Subjects who have received for depression treatment or may have depression.
4. Subjects who have liver disorder, kidney disorder, heart disease, organ disorder, diabetes, hypertension, dyslipidemia, or other serious diseases.
5. Subjects who have had a history of gastrointestinal tract surgery, such as gastrectomy, gastrointestinal suture, or bowel resection.
6. Subjects have received medication.
7. Subjects who have received hormone replacement therapy.
8. Subjects who have irregular lifestyle habits due to night shift or shift work.
9. Subjects who use excessive tobacco or alcohol, or have extremely irregular eating habits.
10. Subjects who have allergies such as food allergies or asthma.
11. Subjects who regularly use drugs, specified health foods, health foods, or supplements that may affect this study.
12. Subjects who had participated in other clinical studies within the last three month prior to the current study.
13. Subjects who do not agree with the purpose of the explanation given in advance.
14. Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Akanuma |
Organization
Akanuma Surgery Clinic
Division name
Director
Zip code
005-0842
Address
2-6-14-1, Ishiyama, Minami-ku, Sapporo, Hokkaido
TEL
011-591-1777
y-kohzai@kyowa-t.com
Public contact
Name of contact person
| 1st name | Yoshimichi |
| Middle name | |
| Last name | Kohzai |
Organization
Kyowa Trial Co., Ltd.
Division name
President
Zip code
064-0923
Address
mimami23-nishi11-1-40, Chuo-ku, Sapporo, Hokkaido
TEL
011-200-9431
Homepage URL
y-kohzai@kyowa-t.com
Sponsor or person
Institute
Kyowa Trial Co., Ltd.
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Akanuma Surgery Clinic Ethics Review Committee
Address
2-6-14-1, Ishiyama, Minami-ku, Sapporo, Hokkaido
Tel
011-591-1777
s-ito@kyowa-t.com
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 | 05 | Month | 31 | 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
15
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 | 01 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 24 | 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 | 01 | Month | 29 | Day |
Last modified on
| 2021 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044826
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