Verification of Safety and Efficacy of Enoki Mushroom Extract Powder Foods in Male Menopausal Symptoms

JRCT ID: jRCTs041220142

Registered date:14/02/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Normal male (healthy male)
• Date of first enrollment: 13/06/2023
• Target sample size: 56
• Study type: Interventional
• Intervention(s): To evaluate menopausal symptoms improvement effect of powdered enoki mushroom extract food in men with menopausal symptoms.

Outcome(s)

• Primary Outcome: Heinemann Aging males symptoms score
• Secondary Outcome: Beck Depression Inventory(BDI2), activity scale for the elderly(ASE), Nocturia Quality-of-Life Questionnaire(N-QOL) , Grip strength test and Skeletal muscle mass test, Total and free testosterone, Pittsburgh Sleep Quality Index( PSQI)

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

1) Men over 40 years of age.
2) AMS score of 27 or more, but less than 50

Exclude criteria

1) Those undergoing treatment for male menopause
2)Within 2 months after completion of treatment for male menopause
3) Patients suffering from lifestyle-related diseases.
4) Those who are taking medicines, newly designated quasi-drugs, herbal medicines, health foods, and supplements related to the promotion of testosterone secretion.
5) Persons who are participating or will participate in other clinical research studies at the time this study is initiated
6) PSA level of 4.0ng/mL or higher
7) Other persons deemed inappropriate by the principal investigator

Related Information

• Primary Sponsor: Ono Ken
• Secondary Sponsor: Yamada Shizuo,TechnoSuruga Laboratory Co., Ltd.