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IRCT20180514039660N1 IRCT 2018-08-07 Mashhad University of Medical Sciences The effect of viola odorata syrup on hot flashes and sleep quality in postmenopausal women The effect of viola odorata syrup on hot flashes and sleep quality in postmenopausal women 2018-06-22 anticipated 94 Complete https://irct.ir/trial/31205 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Firstly, from the 5th and Samen areas of the city of Mashhad, the names of all these centers are written on paper and selected through the drawings of two centers, then from the sub-set of the two centers, each of which has two centers suitable for personnel cooperation and the presence of The menopause women will be selected and the researcher will be present at each of these centers and selected on the basis of the checklist for the selection of the research unit, eligible women to enter the study are available. Then the violet flower syrup from Barij and Placebo, the researcher will be provided by the pharmacist's consultant in similar glasses. Each glass has a code chosen by the random number table, and only the pharmacist's consultant knows. Individuals with entry requirements are assigned code numbers in groups respectively, Blinding description: In order to blind the violet flower syrup from Barij and Placebo, the researcher will be provided by the pharmacist's consultant in similar glasses. Each glass has a code chosen by the random number table, and only the pharmacist's consultant knows. Individuals with entry requirements are assigned code numbers in groups respectively. Therefore, until the end of the study, the research units, researcher and statistician will not be aware of the codes related to violet syrup and placebo. 3 Condition 1: Hot flashes. Condition 2: sleep disorders. Intervention 1: Intervention group: Violet Flower Syrup from Barís Essence, every 5 ml of flavonoid containing syrup is 16.25-9 mg. The units are taking 5 ml every other day forone month each two times a day. Intervention 2: Control group: Use of placebo in similar glasses of syrup; the units are taking 5 ml every other day forone month each two times a day. 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 decision has yet been made on this issue
public Fatemeh Lotfi
Faculty of Nursing and Midwifery, Doctora Crossroads, Daneshgah Street
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 lotfif951@mums.ac.ir Mashhad University of Medical Sciences scientific Fatemeh Zahra Karimi
Faculty of Nursing and Midwifery, Doctora Crossroads, Daneshgah Street
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 Karimifz@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) At least the reading and writing skills Post-menopausal (at least 12 months of self-deprivation of menstruation, without contact with pregnancy and lactation, or other medical and pharmaceutical reasons or serum FSH> 40 IU / L). Experience at least 3 hot flashes throughout the day Having a sleep quality score higher than 5 Age 40 to 65 years old 40 years 65 years Female Tobacco and alcohol consumption Hormone therapy in the last 6 months Having depression, stress or severe anxiety (score less than 19 below the stress scale, score less than 10 below the anxiety scale or score less than 14 below the depression scale of the DASS-21 questionnaire) Having physical illnesses (such as diabetes, hypertension, pulmonary, heart, infectious diseases, cancers) Mental illness Infectious and febrile illnesses (such as respiratory, urinary and hepatitis infections, thyroid disease, and those with hot flush as one of their symptoms). Concomitant use of hypnotic and herbal medicines affecting sleep and hot flashes (such as soy and herbs) Taking medications that improve vasomotor symptoms (such as clonidine, antidepressants, tamoxifen, raloxifene, anticonvulsants like gabapentin) Use of anti-coagulants, anti-anxiety and non-steroidal drugs Having a night shift The use of isoflavone absorption inhibitors during the study, such as antibiotics for 6 weeks, and proton pump inhibitors (omeprazole, lansoprazole, ropiperazole, pantoprazole, osomoperazole) N95.1 G47 Menopausal and female climacteric states Sleep disorders Treatment - Other Placebo Intervention group: Violet Flower Syrup from Barís Essence, every 5 ml of flavonoid containing syrup is 16.25-9 mg. The units are taking 5 ml every other day forone month each two times a day. Control group: Use of placebo in similar glasses of syrup; the units are taking 5 ml every other day forone month each two times a day. Hot flashes. Timepoint: From a week before the study begins to immediately after the intervention. Method of measurement: Hot flashes daily registration form. Sleep quality. Timepoint: Before starting the study until immediately after the intervention. Method of measurement: Pittsburg Sleep Quality Index. Mashhad University of Medical Sciences Approved 2018-05-29 School of Nursing and Midwifery, Mashhad University of Medical Sciences Faculty of Nursing and Midwifery, Doctora Crossroads, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)