peri-menopause Insomnia
Conditions
Interventions
Control:sham-acupuncture
Sponsors
Yueyang Hospital of Intergrated Traditional Chinese andWestern Medicine, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. diagnosis of primary insomnia according to the ICSD-3 criteria for at least 3 months; 2. women in peri-menopause period; 3. total score of Pittsburgh Sleep Quality Index (PSQI) at least 5-point; 4. haven't received any acupuncture treatment.
Exclusion criteria
Exclusion criteria: 1. were taking herbal remedies, over-the-counter medications, or psychotropic drugs that were intended for the treatment of insomnia within the last 2 weeks prior to baseline or during the study; 2. use of hormones or hormonal contraceptives in the past 2 months; 3. were diagnosed to with a concurrent major depressive disorder, generalized anxiety disorder, panic disorder, manic or hypomanic episode, substance use disorder besides caffeine or nicotine use, organic mental disorder, schizophrenia, or any other psychotic disorder based on the Structured Clinical Interview for the DSM-IV (SCID) ; 4. had an apnea-hypopnea index of 10 or greater or a periodic limb movement index with arousal of 15 or greater, as detected during overnight polysomnography; 5. had an infection or abscess close to the site of the selected acupoints; 6. had any serious physical illness; 7. had participated in any clinical trial within the 3 months prior to baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSG;PSQI;ISI;BDI;BAI;FS-14;SF-36; | — |
Countries
China
Contacts
Public ContactChen Yunfei
Outcome results
None listed