perimenopausal insomnia
Conditions
Interventions
Control group:placebo
Experimental group:Liuwei Anshen Capsule
Sponsors
Hubei University of Chinese Medicine
Eligibility
Sex/Gender
Female
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) It meets the diagnostic criteria for perimenopausal syndrome; (2) It meets the diagnostic criteria for insomnia and the Syndrome Differentiation criteria of traditional Chinese medicine for insomnia (yin deficiency and fire excess with phlegm syndrome) (3) Female, 40-60 years old; (4) Be able to understand the content of the scale and actively cooperate with the treatment. Pittsburgh sleep quality index (PSQI) = 7 points (5) Sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Not yet effectively controlled or severe disease (as judged by clinicians), such as persistent pain from various causes, malignancy, cardio cerebrovascular disease (hypertension, coronary atherosclerotic heart disease, cerebral infarction, brain trauma, Parkinson, dementia, epilepsy, etc.), endocrine disease (diabetes, hyperthyroidism, hypothyroidism, etc.) Patients with insomnia due to neuromuscular disorders and digestive disorders (gastroesophageal reflux, etc.). (2) Those with moderate or severe anxiety and depression, psychiatric (HAMD = 20 and HAMA = 14). (3) Pregnant and lactating patients. (4) Involved in other clinical observers. (5) Patients undergoing hormone replacement therapy. (6) Other reason (s) the investigator considered not appropriate to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSQI;polysomnography ( PSG); | — |
Secondary
| Measure | Time frame |
|---|---|
| FSH;LH;E2;The Epworth Sleeping Scale (ESS);BBS;the Kupperman scale;TCM symptom scale;Hamilton Depression Scale(HAMD);Hamilton Anxiety Scale(HAMA);The insomnia severity index(ISI); | — |
Countries
China
Contacts
Public ContactWANG Ping
Hubei University of Chinese Medicine
Outcome results
None listed