UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054558 |
|---|---|
| Receipt number | R000062259 |
| Scientific Title | Monitoring study on the effects of ingestion of a preparation containing a mixture of three plant extracts on male menopause and sexual function. |
| Date of disclosure of the study information | 2024/06/04 |
| Last modified on | 2024/10/03 10:54:40 |
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Basic information
Public title
Monitoring study on the effects of ingestion of a preparation containing a mixture of three plant extracts on male menopause and sexual function.
Acronym
Study to evaluate the effects of a plant extract mixture on male menopause and sexual function.
Scientific Title
Monitoring study on the effects of ingestion of a preparation containing a mixture of three plant extracts on male menopause and sexual function.
Scientific Title:Acronym
Study to evaluate the effects of a plant extract mixture on male menopause and sexual function.
Region
| Japan |
Condition
Condition
Healthy adult males
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of ingestion of a formulation containing three plant extracts on male menopause and sexual function improvement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Free testosterone in saliva (before, 4 weeks after, and 8weeks after intake)
Key secondary outcomes
Aging males' symptoms (AMS score)
Erection Hardness Score (EHS)
Questionnaire on effectiveness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
One capsule containing 200 mg of the plant extracts mixture is taken daily for 8 weeks, followed by a 4-week post-observation period.
Interventions/Control_2
Three capsules containing 200 mg of the plant extracts mixture are taken daily for 8 weeks, followed by a 4-week post-observation period.
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
Male
Key inclusion criteria
1)Male employees aged between 20 and 80 years at the time of obtaining consent to participate in the trial.
2)Healthy participants who are not currently receiving treatment or medication.
3)Participants who are able to collect a specimen on the specified date and submit it by the specified method.
4)Participants who fully understand the purpose and content of the study and are able to give written consent.
Key exclusion criteria
1)Participants who are currently under medical treatment by a physician for any disease.
2)Participants who regularly use health foods containing blackcurrant extract, red perilla extract, or inositol.
3)Participants who regularly use health foods (e.g. maca, krachaidum, fenugreek) or medicines (e.g. testosterone, ED drugs, AGA drugs) related to the male menopause or sexual function.
4)Participants who may have allergic reactions to the test food.
5)Participants with a history or current history of heart failure, renal failure, hepatitis or other diseases.
6)Participants who consume excessive alcohol.
7)Participants who are enrolled in other clinical trials.
8)Participants who plan to change their lifestyle drastically during the study period.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Inagaki |
Organization
JAPAN PHARMA Co., Ltd.
Division name
Osaka Lab.
Zip code
536-8553
Address
In ORIST B5, 1-6-50 Morinomiya, Joto-ku, Osaka 536-8553 Japan
TEL
090-4995-9966
inagaki@japan-pharma.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Inagaki |
Organization
JAPAN PHARMA Co., Ltd.
Division name
Osaka Lab.
Zip code
536-8553
Address
In ORIST B5, 1-6-50 Morinomiya, Joto-ku, Osaka 536-8553 Japan
TEL
090-4995-9966
Homepage URL
inagaki@japan-pharma.jp
Sponsor or person
Institute
JAPAN PHARMA Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Morishita Jintan Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Morishita Jintan
Address
1-2-40, Tamatsukuri, Chuo-Ku, Osaka-shi, Osaka, 540-8566, Japan
Tel
06-6761-1131
public_relations_gr@jintan.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
| 2024 | Year | 06 | Month | 04 | 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
| 2024 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 03 | Day |
Last modified on
| 2024 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062259
