(1) Objectives: Comparison of the efficacy of citalopram and a compound of Asperugo procumbens and foeniculum vulgare in treatment of sleep disorders, depression, sexual disorders, flushing, vaginal dryness, vaginal atrophy, vaginal itching, breast pain and skin changes in menopausal women.
(2) Design: a double blind, randomized, placebo-controlled clinical trial including 60 menopausal women
(3) Setting and conduct: 60 postmenopausal women with the complaint of sleep disorders, who is referred to the menopause clinic of Women’s general hospital and Vali-e-Asr hospital, are studied in this trial. After taking the history and performing general and vaginal examinations, these patients are participated in the study based on the major eligibility criteria. Then they are randomly divided into 3 groups. The first group receives citalopram, the second receives the compound of Asperugo procumbens and foeniculum vulgare, and the third receives placebo.
(4) Participants including major eligibility criteria: major exclusion criteria include drug consumption (eg. antidepressants, benzodiazepines), having psychological disorders such as depression, history of any medical disease such as thyroid disorders, cardiac disease, dyslipidemia, hypertension, diabetes, estrogen-dependent malignancies. Major inclusion criteria include cessation of monthly periods and confirming lab tests for menopause, having complaint of sleep disorders, negative pregnancy test, and normal lab tests including lipoprotein profile, blood sugar, thyroid and CBC in the last year.
(5) Intervention: The first group will receive citalopram 40 mg (start with 20 mg and after one week increase to 40 mg) for 8 weeks, the second group will receive the compound of Asperugo procumbens and foeniculum vulgare 600mg for 8 weeks, and the third group will receive placebo for 8 weeks.
(6) Main outcome measures (variables): sleep disorders, depression, sexual disorders, flushing, vaginal dryness, vaginal atrophy, vaginal itching, breast pain, and skin changes.