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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000040717

Enrollment

Registered

2020-10-01

Start date

2020-06-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Individuals

Interventions

Oral intake of the test food type 1, containing Extract of Hemerocallis fulva : 2 weeks Oral intake of the test food type 2, containing Extract of Hemerocallis fulva: 2 weeks Oral intake of the Placeb

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: [1]Age 20-65, Not person suffering from a disease, desk worker aware of mild sleep disturbance (eg, tired, poor sleeping, shallow sleep etc.) [2]Work schedule: daytime, work 5 days a week, closed twice a week [3]Bedtime and wake-up time are regular, bedtime is before 24 o'clock, sleeping habits generally over 4 hours

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
1) Pittsburgh Sleep Questionnaire (PSQI-J) 2) OSA sleep questionnaire	—

Secondary

Measure	Time frame
Secondary outcomes [1] Physical condition change diary [2] Lifestyle questionnaire Safety [1] Adverse events and side effects	—

Countries

Japan

Contacts

Public ContactYutaka Ogidoh

Okinawa TLO Co., Ltd. Not Division

ogidoh@okinawa-tlo.com098-895-1701

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026