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IRCT20190223042811N1 IRCT 2019-06-03 Babol University of Medical Sciences Effect of Silybum marianum extract on hot flash symptoms in postmenopausal women Evaluation the effect of a preparation from of Silybum marianum on hot flashes in postmenopausal women 2019-01-05 anticipated 80 Complete https://irct.ir/trial/37847 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of randomization in this study is quadruple blocking method and the randomization unit is individual and tool is statistical software. The sequencing will be done by quadruple blocking. Concealing done by using similar capsule box form for both groups, and the data analyzer knows how to allocate the intervention, Blinding description: In this study, patients and the intervening person are completely unaware of which drug they received and delivered. 3 Hot flashes. Intervention 1: Intervention group: capsules containing 250 mg of fruit extract "silybum marianum" twice a day for 8 weeks. Intervention 2: Control group: capsules containing 250 mg of starch powder twice a day for 8 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Zohreh Saberi
Babol University of Medical Sciences, Ganjafrooz Street
Babol Iran (Islamic Republic of) 7615973899 +98 11 3219 4728 Zohrehsaberi90@gmail.com Babol University of Medical Sciences scientific Narjes Gorji
Babol University of Medical Sciences, Ganjafrooz Street
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 4728 nargess_gorji@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Patients aged 40 to 60 years old. 3 times daily from a previous month. Individuals who have been treated at least People who are at least 12 and at most 60 months have passed since the last month. (Menopause) FSH>40 40 years 60 years Female Use smoking, Valkel cigarettes. People with underlying diseases (liver, kidney, metabolic disorders such as thyroid problems) are. They have a history of sensitivity to herbal medicines. People who have a history of using anxiolytics, antidepressant, estrogen and progesterone hormones in the last 6 months, use anticoagulant and anti-inflammatory drugs like ibuprofen and other drugs affecting hot flashes. People who have a history of asthma and allergies. Pathologic and ultrasonography have been reported in the uterus. Have a history of mass or malignancy in the breast, ovary or uterus. Do not have natural blood pressure. Have a history of thromboembolism. N95.1 Menopausal and female climacteric states Treatment - Drugs Placebo Intervention group: capsules containing 250 mg of fruit extract "silybum marianum" twice a day for 8 weeks Control group: capsules containing 250 mg of starch powder twice a day for 8 weeks Hot flashes. Timepoint: At the beginning of treatment, weeks 4 and 8 during treatment and 4 weeks after treatment. Method of measurement: The standard GREEN questionnaire, HFRDIS. The frequency of hot flashes. Timepoint: At the beginning of treatment, weeks 4 and 8 during treatment and 4 weeks after treatment. Method of measurement: Daily Inventory of Hot flashes. Babol University of Medical Sciences Approved 2019-01-05 Institutional Research Ethics Committee, Health Research Institute, Babol University of Medical Scie University of Medical Sciences, Babol University of Medical Sciences, Babol, Iran Babol Mazandaran Iran (Islamic Republic of)