SOUJAKU & HISUI study

Not Applicable

• Conditions: Healthy adult male

• Registration Number: JPRN-jRCTs031220545
• Lead Sponsor: Miyata Akinobu

Brief Summary

Men aged 30 to 59 who were unable to conceive naturally with a specific partner were evaluated for the condition of their sperm after taking two test products for 12 or 24 weeks.Regarding sperm analysis, a significant increase in total sperm count was observed after 12 and 24 weeks in the B group compared to C group. In the A group, a significant increase in sperm concentration and total sperm count was observed after 24 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-27
• Study Completion: 2023-07-11
• Results First Posted: 2024-01-31
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 29

Inclusion 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.

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified