menopause symptom
Conditions
Interventions
Oral ingestion of the test product (4T/day, 12weeks)
Oral ingestion of the test product (4T/day, 12weeks)
Sponsors
Research Center for Immunological Analysis, Inc.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: [1] Japanese females at least 50 years of age but not older than or equal to 60 at the time of informed consent [2] Individuals who occured natural menopause in the past 5 years [3] Individuals judged approproate for the study by the principal [4] Individuals who scored less than or equal to 65 on the simplified Menopausal Index score [5] Individuals who scored less than or equal to 49 on the self-rating depression scale score , and a score of suicidal ideation is 1
Exclusion criteria
Exclusion criteria: [1] Individuals judged to require treatment for menopause symptom including medicament therapy [2] Individuals who are treated for menopause symptom or menopausal disorder [3] Individuals who has been diagnosed with menopausal disorder [4] Individuals who had a habit to ingest drugs, health-promoting foods, foods for specified health uses, health foods, or supplements affecting menopause symptom or test results in the past 3 month or will ingest those drugs or foods during the test peripd [5] Individuals who have or had an allergy or asthma to food or drug [6] Individuals who have a disease needing immediate treatment or serious complication [7] Individuals who have or had a digestive disorder that effects digestion and absorption [8] Individuals who have a history of breast cancer, uterine cancer, or hormone dependent cancer [9] Individuals who have a history of serious liver disease, Kidney disease, heart disease, lung disease, or blood disease [10] Individuals who have a mental disorder [11] Individuals who have an anamnesis or a history of present illness of drug dependence or alcohol dependence [12] Individuals who participated in other clinical studies in the past 3months [13] Individuals who are or are possibly pregnant, or are lactating [14] Individuals judged inappropriate for the study by the principal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Questionnaire for Assessment of menopause symptom in japanese women (question number: 5, 12, 17, 18) (Visual Analog Scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| Questionnaire for Assessment of menopause symptom in japanese women (question number: 1,2,3,4,6,7,8,9,10,11,13,14,15,16,19,20,21) (Visual Analog Scale) | — |
Countries
Japan
Contacts
Public ContactHidenori Matsuzaki
Research Center for Immunological Analysis, Inc. none
Outcome results
None listed