Perimenopause-related sleep disturbances
Conditions
Interventions
Control Group:Zopiclone
Experimental Group two:Zhumian-Tang combined with zopiclone
Experimental Group one:Zhumian-Tang
Sponsors
Sichuan Provincial Hospital of Integrative Medicine
Eligibility
Sex/Gender
Female
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Female participants aged 40-60 years; (2) Meeting diagnostic criteria for perimenopause as defined by the Stages of Reproductive Aging Workshop (STRAW) staging system; (3) Meeting diagnostic criteria for sleep disturbances as defined by the International Classification of Sleep Disorders 3rd Edition (ICSD-3); (4) Voluntary participation in the clinical trial with provision of written informed consent.
Exclusion criteria
Exclusion criteria: (1)Non-natural menstrual cycle alterations induced by surgical interventions radiotherapy or pharmacological treatments; (2) Sleep disorders secondary to other disease such as obstructive sleep apnea syndrome restless legs syndrome etc; (3) Patients with major depression [Patient Health Questionnaire 9 (PHQ-9) score = 15]; (4) Patients with severe anxiety [Generalised Anxiety Disorder-7 (GAD-7) score = 15]; (5) Recent use of hormone replacement therapy or sleep-modulating pharmacotherapy within 4 weeks prior to enrollment.; (6) Current pregnancy lactation planned conception during the study period or documented psychiatric disorder; (7) Hepatic/renal dysfunction with laboratory values =1.5 times the upper limit of normal (8) Hypersensitivity to the ingredients of the drugs used in this trial (9) Concurrent enrollment in other interventional clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Follicle stimulating hormon (FSH);Luteinising hormone (LH);Treatment Emergent Symptom Scale(TESS);Modified Kupperman Index (MKI);Generalised Anxiety Disorder-7 (GAD-7);Estradiol (E2);Patient Health Questionnaire 9 (PHQ-9); | — |
Countries
China
Contacts
Public ContactSunjungang
Sichuan Provincial Hospital of Integrative Medicine
Outcome results
None listed