Safety and efficacy of a dietary supplement containing bovine alpha S1-casein tryptic hydrolysate and Hemerocallis fulva on sleep disorders among Japanese adults
Not Applicable
- Conditions
- sleep disorders
- Registration Number
- JPRN-UMIN000013349
- Lead Sponsor
- DHC Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Not provided
Exclusion Criteria
- Subjects who have an inappropriate clinical history for efficacy and safety assessment in the study (such as drug abuse, alcoholism, and the disease of heart, liver, kidney, lungs, eye, blood etc) and who is taking any drugs. - Subjects judged to be inappropriate for the study by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is evaluation of sleep quality with a portable physiological signal recorder.
- Secondary Outcome Measures
Name Time Method PSQI (Pittsburgh sleep quality index) and OSA-MA(OSA sleep inventory MA version).