Effects of melatonin and zolpidem compared with placebo on sleep disorders in premenopause and menopause wome
- Conditions
- Sleep disorder due to premenopause and menopause.Menopausal and female climacteric states
- Registration Number
- IRCT2014010216035N1
- Lead Sponsor
- Guilan university of medical sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 90
diagnosis of Pre- menopause and menopause to be confirmed; the absence of chronic medical conditions that can lead to sleep disorders. Exclusion criteria: Failure to diagnosis the menopause and premenopause; use of psychiatric drugs such as anti-psychotics and hypnotics and mood stabilizer drugs; chronic medical conditions leading to sleep disorders (diabetes, cardiovascular diseases, obesity ); autoimmune Diseases; contraindication of taking melatonin (receiving medication of immunosuppressive drugs, sensitivity to melatonin, high blood pressure, liver dysfunction, history of seizures ); sensitivity to Zolpidm; receiving HRT ( hormone replacement therapy ); sleep disorder caused by taking certain psychiatric disorders ( major depression , bipolar, anxiety, dementia); disasters and adverse event
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sleep Quality. Timepoint: 6 weeks. Method of measurement: Subjective Sleep Quality Questionnaire(PSQI).
- Secondary Outcome Measures
Name Time Method Quality of life. Timepoint: 6 weeks. Method of measurement: SF-36 Quality of Life Questionnaire.