Monitoring study on the effects of ingestion of a preparation containing a mixture of three plant extracts on male menopause and sexual function.

UMIN ID: UMIN000054558

Registered date:04/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy adult males
• Date of first enrollment: 2024/06/04
• Target sample size: 28
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

One capsule containing 200 mg of the plant extracts mixture is taken daily for 8 weeks, followed by a 4-week post-observation period.
Three capsules containing 200 mg of the plant extracts mixture are taken daily for 8 weeks, followed by a 4-week post-observation period.

Outcome(s)

• Primary Outcome: Free testosterone in saliva (before, 4 weeks after, and 8weeks after intake)
• Secondary Outcome: Aging males' symptoms (AMS score) Erection Hardness Score (EHS) Questionnaire on effectiveness

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male
• Exclude 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.

Related Information

• Primary Sponsor: JAPAN PHARMA Co., Ltd.
• Secondary Sponsor: Morishita Jintan Co., Ltd.
• Source(s) of Monetary Support: None