Healthy adults
Conditions
Sponsors
MIS Co.,Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Japanese women aged 40 to 60 years old at the time of obtaining online consent. 2.Subjects with a T-score of 50 or higher for the Tension-Anxiety (TA) component of the POMS2 Adult Short Version and a total score of 50 or lower on the SMI. 3.Subjects who have been fully explained the purpose and contents of the study, are capable of consenting, fully understand the content, and voluntarily volunteer to participate in the study and agree to participate in the study in writing.
Exclusion criteria
Exclusion criteria: 1.Subjects who have been diagnosed with menopausal symptoms by a physician. 2.Subjects who are taking medication or under medical therapy. 3.Subjects who are under exercise therapy or dietetic therapy. 4.Subjects with current or history of drug dependence or alcohol dependence. 5.Subjects who are hospitalized for mental disorders (depression, etc.) or sleep. disorders(insomnia, sleep apnea, etc.), or have a history of mental disorders in the past. 6.Subjects with irregular life rhythms due to night shifts or shift work. 7.Subjects with extremely irregular lifestyle habits such as eating and sleeping. 8.Subjects who drink excessive alcohol or those at risk of becoming excessive drinkers. 9.Subjects who have an extremely unbalanced diet. 10.Subjects with serious current or previous illnesses such as brain disease, malignancy, immunological disease, diabetes, liver disease (hepatitis), renal disease, cardiac disease, thyroid disease, adrenal gland disease, tendon disease, joint contracture, orthopedic disease, or other metabolic diseases. 11.Subjects using health foods, supplements, or medications that affect mental status (anxiety, tension, depression, etc.), the central nervous system, or menopausal symptoms (e.g., anti-anxiety drugs, antidepressants, sleeping pills, first-generation antihistamines, hormone preparations, equol-containing foods, St. John's wort, GABA, theanine, etc.). *These are examples only, and are not limited to these. 12.Subjects who have participated in other clinical trials (research) within 3 months from the date of consent acquisition or who plan to participate in other clinical trials (research) during the trial period. 13.Subjects who have collected 200 mL of blood or donated more than 400 mL of blood within 3 months from the date of consent acquisition. 14.Subjects who are planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| POMS2 Adult Short Version [Tension-Anxiety (TA)] T-Score | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) POMS2 Adult Short Form TMD T-score, POMS2 Adult Short Form T-score (excluding TA), SMI (Safety evaluation) Adverse events | — |
Countries
Japan
Contacts
Public ContactMasao Matsuoka
MIS Co.,Ltd. Clinical Development Department
Outcome results
None listed