Perimenopausal Insomnia
Conditions
Interventions
Sponsors
Shanghai Municipal Hospital Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
45 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Women aged 45-60 years; 2.Insomnia; 3.Perimenopausal symptoms; 4.PSQI>= 6and KI>=15; 5.No sedatives and sleeping pills,or Stop taking sleeping pills more than two weeks.
Exclusion criteria
Exclusion criteria: 1. Premature ovarian failure or bilateral ovariectomy due to other diseases; 2. With mental illness; 3. HAMA >= 14 and(or) HAMD >= 18; 4. Obvious symptoms of heart, liver, kidney or other systems; 5. Laboratory examination and ECG examination have obvious clinical significance abnormalities, which can affect the drug evaluation or the safety of the subjects; 7. AST and ALT were 2.0 times higher than the upper limit of normal value; 8. Those who have severe allergic constitution or are known to be allergic to traditional Chinese medicine ingredients used in this study; 9. Those who have severe allergic constitution or known to be allergic to traditional Chinese medicine ingredients used in this study have received sex hormone drug treatment or participated in other clinical trials in the past one month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSQI, KI, HAMA, HAMD; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM symptom scale; | — |
Countries
China
Contacts
Public Contactwanghuiru
Shanghai Traditional Chinese Medicine Hospital
Outcome results
None listed