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Investigation of the quality pf sleep effects of food containing Extract of Hemerocallis fulva: A randomized double-blind placebo-controlled parallel-group study

Not Applicable
Conditions
Healthy Individuals
Registration Number
JPRN-UMIN000040717
Lead Sponsor
ahanishi Clinic.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
Male
Target Recruitment
63
Inclusion Criteria

Not provided

Exclusion Criteria

[1]Individuals who are Suspected sleep apnea syndrome (SAS) or during treatment and medical history [2]Individuals Who are Nocturia, benign prostatic hyperplasia, person with overactive bladder, suspected [3]Those who have an existing medical condition such as liver disease, renal disease, cardiovascular disease, digestive organ disease, respiratory disease, blood system disease, autoimmune disease, endocrine system disease and metabolic disease [4]Individuals who are medical allergy or serious food allergy [5]Individuals who are pregnant, those who intend to become pregnant during the test period, those who are breastfeeding [6]Individuals who are regularly use medicines, quasi-drugs, supplements, etc. relating to stress improvement and sleep improvement [7]Individuals who excessively take alcohol(expressed in an amount of alcohol: over 60g/day) [8]Individuals judged inappropriate for the study by the principal and research director

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1) Pittsburgh Sleep Questionnaire (PSQI-J) 2) OSA sleep questionnaire
Secondary Outcome Measures
NameTimeMethod
*Secondary outcomes [1] Physical condition change diary [2] Lifestyle questionnaire *Safety [1] Adverse events and side effects
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