Perimenopausal syndrome insomnia with depression and anxiety
Conditions
Interventions
Control group:Give Kuntai capsules orally for 2 months
Treatment group:Give kidney tranquility prescription decoction orally for 2 months
Sponsors
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
Female
Age
45 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1 perimenopausal female aged 45-55 years. 2 Meet the diagnostic criteria and scoring basis for insomnia, depression and anxiety. 3 Meet the diagnostic criteria of TCM dialectical heart-kidney incompatibility. 4There is no history of allergy to the drug under study. 5. Voluntarily participate in this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1 Patients with primary diseases such as cardiac, hepatic, and renal insufficiency are not suitable for patients participating in this experiment. 2 Patients with organic insomnia caused by insufficient cerebral blood supply, cardiovascular and cerebrovascular diseases, poisoning, and diseases of the five senses. 3 Patients with insomnia caused by other psychiatric disorders (in addition to perimenopausal depression and anxiety) or other factors such as various drugs. 4 Patients with severe depression and anxiety symptoms > 35 points on the Hamilton Depression Scale (24 items) and or the Hamiltonian Anxiety Scale (14 items) > 29 points. 5 ongoing and continuing hormone replacement therapy treatment or other TCM treatments; or patients who have undergone normative treatment for insomnia and depression and anxiety within the last 4 weeks. 6 There are bad living habits such as drug use, smoking, alcoholism, and long-term playing of mobile phones and computers at night, which may affect sleep. 7 Patients with severe organic gynecological diseases, such as cervical cancer, tumors, etc. 8 Patients with fertility needs. 9 Patients who take contraceptive rings containing estrogen and progesterone components such as Manyuele rings for contraception. 10 Patients with severe insomnia, depression, anxiety symptoms that affect life and need to take Western medicine. 11 patients with severe drug allergies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Mass Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Domestic improvement of the Kupperman rating scale;Serum sex hormones E2, FSH, LH;Hamilton Depression Scale;Endometrial thickness;Hamilton Anxiety Scale;TCM Syndrome Sub-List; | — |
Countries
China
Contacts
Public ContactJinghong Xie
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed