Healty volunteers
Conditions
Interventions
Sponsors
MITSUBISHI GAS CHEMICAL COMPANY, INC.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Japanese women aged 20 to 55 2) Those who have problems with sleep quality 3) Those with a regular menstrual cycle (25-38 days) 4) Those who have a tendency towards premenstrual syndrome 5) Healthy individuals who are not undergoing treatment for any illness or taking any medication 6) Those who voluntarily wish to participate in the clinical trial and can provide written informed consent 7)Those who can maintain a consistent daily lifestyle during the test period
Exclusion criteria
Exclusion criteria: 1) Those who have been taking medicines regularly within the last 3 months prior to the start of the study (excluding temporary medications such as painkillers and cold medicines) 2) Those with serious illnesses (diabetes, heart disease, liver disease, kidney disease, cancer, etc.) or mental illnesses 3) Those with a history of serious illness (diabetes, heart disease, liver disease, kidney disease, cancer, etc.) or digestive system disease 4) Those who have regularly taken specific health foods, functional foods, health foods (including supplements), etc., that may affect the study, at least three times a week within three months prior to the start of the study. 5) Those who cannot stop taking foods for specified health uses, foods with functional claims, health foods (including supplements), etc. that may affect the study during the study period. 6) Those whose menstruation has stopped completely 7) Those who are pregnant or breastfeeding, or who plan to or wish to do so during the study period 8) Those who live in an environment where sleep is disturbed by factors other than themselves, such as living with infants or people who require care 9) Those who drink a lot of alcohol (40g or more of pure alcohol per day on average) 10) Those with extremely irregular eating habits or those with irregular lifestyles such as working night shifts 11) Those with drug or food allergies 12) Participants in clinical trials related to sleep quality or PMS within 6 months of the start of the study 13) Those who are currently participating in another clinical trial, have completed a clinical trial within the last 4 weeks, or are scheduled to participate in another clinical trial while participating in this study. 14) Those who are deemed ineligible to participate in this study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pittsburgh sleep quality index(PSQI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Daily Record of Severity of Problems(DRSP) Fatigue Visual Analog Scale Body composition measurement Skin condition Fitbit Sleep Profiles Blood growth hormone concentration | — |
Countries
Japan
Contacts
Public ContactTatsuo Uetake
CXwellness, Inc. Representative Directo
Outcome results
None listed