Perimenopausal insomnia
Conditions
Interventions
Research Group:Perform floating needle therapy at the Shenshi period
Control Group:Guipi Capsules for Oral Use
Sponsors
Hangzhou Red Cross Hospital
Eligibility
Sex/Gender
Female
Age
45 Years to 55 Years
Inclusion criteria
Inclusion criteria: Western medical diagnostic criteria for perimenopause: Refer to the relevant standards in "Chinese Obstetrics and Gynecology". Follicle-stimulating hormone (FSH) > 10 mIU/mL, anti-Müllerian hormone < 1.1 ng/mL, accompanied by menstrual disorders, hot flashes, etc. Western medical diagnostic criteria for insomnia: Refer to the relevant standards in "The Third Edition of the Classification and Diagnosis of Mental Disorders (Mental Disorder Classification)" of China. Difficulty falling asleep, frequent dreams, easily awakened, difficulty falling asleep after waking up, daily sleep time < 4 hours, = 3 days per week, and lasting for = 2 weeks. Chinese medical diagnostic criteria for perimenopause: Refer to the relevant contents in "Materia Medica Gynecology" (edited by Luo Songping, 2015) and "Interpretation of Clinical Diagnosis Guidelines for Traditional Chinese Medicine - Gynecological Diseases Volume" (edited by Du Huilan, 2015). 1) Main symptoms: hot flashes, sweating, restlessness, frequent dreams, easily awakened, insomnia; 2) Secondary symptoms: menstrual disorders, mental distraction, dizziness, tinnitus, palpitations, forgetfulness, hot hands and feet, weak waist and knees, etc.; 3) Tongue and pulse: red tongue, less coating, fine and rapid or fine and tense pulse. The main symptoms are necessary, and 3 or more of the secondary symptoms, combined with the tongue and pulse, can diagnose the condition. Diagnosis criteria for heart-spleen deficiency type insomnia: Refer to the "Chinese Disease Syndrome Diagnosis and Efficacy Standards". Manifested as frequent awakening, or blurred and unreal dreams, palpitations, forgetfulness, dizziness, blurred vision, fatigue, pale complexion, thin tongue, thin coating, fine and weak pulse. Inclusion criteria are: 1) Meet the above Western medical diagnostic criteria and Chinese medical syndrome diagnosis criteria; 2) Age 45-55 years old; 4) Pittsburgh Sleep Quality Index (PSQI) score = 7 points; 5) Disease duration = 1 month; 6) Patients or their family members sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Those with insomnia caused by other diseases; 2) Those with severe primary diseases such as cardiovascular, liver, kidney and hematopoietic system disorders; 3) Those with gynecological malignancies or unexplained vaginal bleeding; 4) Patients with severe mental disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine efficacy indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Western medical efficacy indicators;Pittsburgh Sleep Quality Inde; | — |
Countries
China
Contacts
Public ContactMeng Shi
Hangzhou Red Cross Hospital
Outcome results
None listed