Menopausal syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women aged 45 to 60; 2. Meet the criteria for menopausal syndrome as outlined in the *Guidelines for the Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Menopausal Syndrome (2023 Edition)*; 3. Have a total score on the Modified Kupperman Scale of >15; 4. Able to read Chinese, accurately understand the trial procedures, voluntarily participate in the trial, and sign the informed consent form; 5. Able to cooperate with and attend follow-up visits as scheduled, promptly report any changes in health status or dietary habits, as well as symptoms of adverse reactions, and able to comply with study requirements and the study schedule.
Exclusion criteria
Exclusion criteria: 1. Suffer from diseases of important organs such as heart, liver, lungs, and kidneys, blood diseases, or malignant tumors; 2. Have severe mental disorders, are unable to control their own behavior, or are unable to cooperate as subjects; 3. Suffer from endometrial hyperplasia, uterine cancer, endometrial cancer, breast cancer, or other breast diseases, or diseases related to sex hormones; 4. Have undergone hysterectomy, bilateral oophorectomy, or other causes of artificial menopause, such as radiotherapy or chemotherapy; 5. Have experienced severe migraines, thromboembolism, cerebrovascular diseases, myocardial infarction, been diagnosed with angina pectoris, or undergone coronary artery surgery within the past year; 6. Suffer from severe mental disorders such as depression or anxiety, or are currently taking antidepressants, sleeping pills, or other medications related to the nervous system; 7. Have taken or received treatment for abnormal uterine bleeding or related conditions after menopause; 8. Have a history of hyperthyroidism, hypothyroidism, or hyperlipidemia and still require drug treatment; 9. Have used health supplements or medications related to the functions being tested within the past month, which may affect the evaluation of results (e.g., vitamins, antioxidants, fatigue-relief products, lipid-regulating products, or cardiovascular health-related products); 10. Are regular medication users, heavy drinkers, or heavy smokers; 11. Have an allergic constitution or are allergic to the test product; 12. Are pregnant, planning to become pregnant, or breastfeeding; 13. Have participated in or are currently participating in other clinical trials within the past three months; 14. Are deemed unsuitable for participation in this trial by the investigator or are at high risk of being lost to follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Kupperman Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Menopause Quality of Life Questionnaire (MENQOL);Self-Rating Anxiety Scale (SAS);Self-Rating Depression Scale (SDS) ;Pittsburgh Sleep Quality Index (PSQI);Hormone levels: Follicle-stimulating hormone (FSH), estradiol (E2), luteinizing hormone (LH), anti-Müllerian hormone (AMH); | — |
Countries
China
Contacts
Shaanxi Provincial Hospital of Traditional Chinese Medicine