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IRCT2013010110324N7 IRCT 2013-04-10 Vice chancellor for research, Tabriz University of Medical Sciences Effect of Humulus Lupulus on early menopausal symptoms in menopausal and perimenopausal women Effect of Humulus Lupulus on early menopausal symptoms in menopausal and perimenopausal women: A Randomised Controlled Trial 2013-04-21 anticipated 120 Complete https://irct.ir/trial/10788 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2-3 Menopause. Intervention 1: The intervention group will receive 500 mg Humulus Lupulus tablet daily for 90 days. Glandular powder separated from the strobiles of the Humulus lupulus (hops) plant will be used for making tablets. Intervention 2: The control group will receive 500 mg placebo tablet daily for 90 days. Placebo tablets contain lactose.
public Aghamiri Vida
Nursing & Midwifery Faculty, South Shariati Street
East Azerbaijan Iran (Islamic Republic of) 66156-15733 +98 87 1222 8597 aghamiri.vida@gmail.com; vida_bist@yahoo.com Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences scientific Dr. Mozhgan Mirghafourvand
Nursing & Midwifery Faculty, South Shariati Street
Tabriz Iran (Islamic Republic of) 347-51745 +98 41 1479 6770 Mirghafourvandm@tbzmed.ac.ir; mirg1385@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Married women aged 40 to 60 years; Willingness to participate in the study; Complaining of hot flashes; having literacy and being able to answer questions; having a Phone; having a score greater than 15 and less than 42 based on Greene scale. Exclusion criteria: Taking drugs including sulfonamides, methotrexate, triamterene, sulfasalazine, estrogen, phenytoin, benzodiazepines, antidepressants, antithyroid, chemical drugs and multivitamin; hormone therapy and the use of OCP during the last 3 months, using vegetable alternative supplement for vasomotor symptoms during the past month; Contraindications of hormone therapy including suspected or known breast or endometrial cancer, undiagnosed abnormal vaginal bleeding, active thromboembolic disorders and active disease of liver or gallbladder; sensitive to lactose; use of medicines that cause hot flushes including breast cancer treatment drugs like letrozole, raloxifene, amlodipine, Bethanecol, hydrochloride, desmopressin and calcitonin. 40 years 60 years Female N95.1, N95 Menopausal and female climacteric states, Other specified menopausal and perimenopausal disorders Treatment - Drugs Placebo The intervention group will receive 500 mg Humulus Lupulus tablet daily for 90 days. Glandular powder separated from the strobiles of the Humulus lupulus (hops) plant will be used for making tablets The control group will receive 500 mg placebo tablet daily for 90 days. Placebo tablets contain lactose Total and subdomains scores of early menopause symptoms in perimenopausal women. Timepoint: Before intervention, 4, 8 and 12 weeks after intervention. Method of measurement: Greene scale. Total and subdomains scores of early menopause symptoms in postmenopausal women. Timepoint: Before intervention, 4, 8 and 12 weeks after intervention. Method of measurement: Greene scale. Frequency of hot flashes in perimenopausal women. Timepoint: Before interventions, 4, 8 and 12 weeks after intervention. Method of measurement: Checklist for daily counts. Frequency of hot flashes in postmenopausal women. Timepoint: Before intervention, 4, 8 and 12 weeks after intervention. Method of measurement: Checklist for daily counts. Comparison of the effect of Humulus Lupulus on early menopause symptoms and frequency of hot flushes in postmenopausal and perimenopausal women. Timepoint: 4, 8 and 12 weeks after intervention. Method of measurement: Greene scale and Checklist for daily counts. - - Vice chancellor for research, Tabriz University of Medical Sciences Approved 2013-02-18 Ethics committee of Tabriz University of Medical Sciences Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East Azerbaijan Tabriz Iran (Islamic Republic of)