Improvement of sleep characteristics in patients with Postmenopausal insomnia Mental and Behavioural Disorders
Conditions
Interventions
This study will consist of 3 phases: Screening (Days -7 to -1), Trial (Day 0 to Day 14) and Follow-up (Day 15 to Day 18). The test product is plant-based sleep aid sustained release tablet containing
Sponsors
Sichuan Credit Pharmaceutical Co., Ltd, China
Eligibility
Sex/Gender
Female
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age 40-60 years old (inclusive) 2. Meets the diagnostic criteria for menopausal insomnia 3. The modified Kupperman score is > 15, and the insomnia score is =4 4. Pittsburgh Sleep Quality Index (PSQI) score >8 5. Insomnia Severity Index (ISI) score >14 6. Subjects must have discontinued menopausal hormone therapy (MHT) for one month or more, or have never used MHT 7. Subjects must discontinue any medications, psychotherapies, physical therapies, traditional Chinese medicine treatments, health supplements, etc. that improve sleep for one week or more, or have never received such treatment or consumed them. 8. The participants were informed and signed an informed consent form
Exclusion criteria
Exclusion criteria: 1. Patients who are known or suspected of being allergic to any of the ingredients of this product (melatonin, L-theanine, valerian extract, magnesium oxide, black cohosh extract, oryzanol and excipients), or who have a history of severe, life-threatening or other significant allergies to any food or drug 2. Those who are currently consuming or taking food or medicine containing the functional ingredients of this product 3. Those who have participated in other clinical trials within the past 1 month 4. Those who have known serious diseases of the cardiovascular or hematopoietic system, or internal organ diseases such as liver and kidney disease, including decompensated cirrhosis and chronic kidney disease stage IV and above 5. Patients with known severe organic lesions or malignant tumors of the reproductive organs, especially sex hormone-dependent malignant tumors 6. Patients with known or highly suspected uterine fibroids, or pelvic ultrasound showing uterine fibroids greater than 3 cm 7. Patients with known breast cancer, or those with a breast BI-RADS classification of 4 or higher 8. Patients with known autoimmune diseases such as rheumatoid arthritis, or hyperthyroidism, or those with abnormal thyroid function test results 9. Patients with unexplained vaginal bleeding within 1 month, including bleeding related to tumors, inflammation, medical procedures, trauma or ovarian dysfunction 10. Those with a HAMA anxiety scale score of 14 or higher, or a HAMD-17 depression scale score of 18 or higher during screening 11. Patients who are planning to become pregnant, or whose blood pregnancy test results are positive 12. Patients with severe mental illness, or alcohol or drug dependence 13. Patients with laboratory test results showing serum creatinine above the upper limit of normal, and ALT or AST 2 times the upper limit of normal or higher 14. Those who have participated in or plan to participate in weight loss activities, or change the frequency and intensity of exercise within 30 days prior to screening and during the trial period 15. Those whom the researchers determine have other circumstances that may hinder compliance, prevent completion of the study, harm participant health, or interfere with study outcomes
Countries
China
Contacts
Public ContactJian Yu
Outcome results
None listed