Clinical trial of Liuwei Anshen capsule in the treatment of perimenopausal insomnia
- Conditions
- perimenopausal insomnia
- Registration Number
- ITMCTR2200006697
- Lead Sponsor
- Hubei University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- Not specified
(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.
(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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PSQI;polysomnography ( PSG);
- Secondary Outcome Measures
Name Time Method 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);