SOUJAKU & HISUI study

JRCT ID: jRCTs031220545

Registered date:27/12/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy adult male
• Date of first enrollment: 05/01/2023
• Target sample size: 45
• Study type: Interventional
• Intervention(s): Subjects are divided into 3 groups (12-week intake group, 24-week intake group, non-intervention group) to evaluate the effect on sperm.

Outcome(s)

• Primary Outcome: Sperm count, Normal morphology rate of sperm, Sperm motility
• Secondary Outcome: subjective assessment

Key inclusion & exclusion criteria

• Age minimum: >= 30age old
• Age maximum: <= 59age old
• Gender: Male

Include criteria

1.Male aged 30 to 59
2.Those who have been trying to conceive with a specific partner for more than a year and have not been able to conceive naturally.
3.Subjects with a BMI value of 19 or more and less than 30
4.Subjects who fully understood the participation in this research and gave written consent of their own free will.

Exclude criteria

1.Subjects with a BMI value of less than 19 or 30 or more
2. Subjects who are receiving treatment, medication, or lifestyle guidance from a doctor for dyslipidemia or diabetes
3.Subjects who continue strenuous exercise on a daily basis
4.Those who tend to go to bed/start time irregularly and are sleep deprived
5. Subjects who habitually use the sauna
6. Excessive smokers and regular alcohol users
7.Those who are taking AGA drugs
8. Subjects who are exposed to excessive stress on a daily basis
9.Subjects who are likely to show allergic symptoms to drugs or foods
10. Severe cerebrovascular disease, heart disease, liver disease, kidney disease, digestive system disease, infectious diseases requiring notification, etc.suffering from
11. Those who use a pacemaker or defibrillator
12.Patients with a history of major gastrointestinal surgery such as gastrectomy, gastrointestinal suture, intestinal resection
13.Subjects with significant abnormalities in blood pressure measurement and blood tests
14.Subjects with severe anemia
15.Subjects who have participated in, or plan to participate in, other clinical studies that are affected by this study within one month prior to obtaining informed consent
16.In addition, those who are judged to be inappropriate by the principal investigator

Related Information

• Primary Sponsor: Miyata Akinobu
• Source(s) of Monetary Support: RINDO KANPO Co.,Ltd