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IRCT20210208050295N1 IRCT 2021-03-03 Mashhad University of Medical Sciences The effect of Rosa damascena mill on menopausal symptoms The effect of oral capsules Rosa damascena mill extract on menopausal symptoms 2021-04-21 anticipated 78 Complete https://irct.ir/trial/54221 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling will be done in all 8 comprehensive centers of health services in Gorgan. The researcher is present in each of these centers and based on the selecting the research unit checklist, women who are eligible to enter the study are selected as available method. The capsule containing Rosa damascena mill extract and placebo is provided to the researcher by the pharmacist consulting professor in similar forms with two different codes and only the pharmacist consulting professor is aware of the codes. Individuals eligible for the study will be randomly assigned to the drug or placebo group by random sequence, Blinding description: In order to blind the capsule of Rosa damascena mill extract and placebo in similar shapes and completely identical packages are provided to the researcher. Each of them has a code that only the pharmacist consultant knows. Eligible individual are randomly assigned to drug or placebo groups by random sequence. Therefore until the end of the study research units, researcher and statistician will not be aware of the codes related to drug and placebo groups. 3 menopausal symptoms. Intervention 1: Intervention group: In this group, research units take a 500 mg capsule containing Rosa damascena mill hydro-alcoholic extract every 12 hours for 8 weeks. These capsules are prepared in the Department of Medicinal Plants Pharmacology of Mashhad University of Medical Sciences. According to the studies presented on Rosa damascena mill, 71 mg / kg per day of the alcoholic extract of this plant will not be toxic to humans. Intervention 2: Control group: In this group, research units take a placebo capsule every 12 hours for 8 weeks. Each of these capsules contains 500 mg of Avisel powder and is made with the appearance and packaging similar to Rosa damascena capsule in the Department of Medicinal Plants of Mashhad University of Medical Sciences. 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 -
public Zohre Gholinezhad
School of Nursing and Midwifery ,Doktota Crossroads, ,DaneshgahStreet,
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 Gholinezhadz982@mums.ac.ir Mashhad University of Medical Sciences scientific Fatemeh zahra Karimi
School of Nursing and Midwifery,Doktora 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) Having a minimum education in primary school Age 45 to 65 years old Having a normal menopause (stopping menstruation for at least one year after 45 years old, without interfering with pregnancy and lactation, surgery, medication and pathology) Married and living with her husband Having sexual intercourse in the last month Obtained at least 5 score from the initial MRS Lack of known and treated medical diseases which affect the results of the study (cardiovascular, liver, kidney, chronic lung disorders, thyroid, neurology and psychiatry diseases, musculoskeletal, pelvic prolapse, urinary disorders and neurological diseases known and treated ) No history of cancer 45 years 60 years Female Drug addiction, smoking and alcohol abuse Taken medicine that improve menopausal symptoms in the last 6 months (Such as estrogen and progesterone, GnRH agonists and antagonists, clonidine, gabapentin, serotonin and norepinephrine inhibitors, paroxetine, venlafaxine, vitamin E, methyldopa, naloxone and tibolone) Use of complementary medicine to improve menopausal symptoms (such as herbs, acupuncture and acupressure) during the last 6 months Women professional athletes or women with severe mobility limitations who are unable to do housework GA30.00 Any condition of the genital system affecting females, caused by pathological changes associated with the perimenopausal period, such as the permanent cessation of menstruation and infertility. Includes: Symptoms such as flushing, sleeplessness, headache, Treatment - Other Placebo Intervention group: In this group, research units take a 500 mg capsule containing Rosa damascena mill hydro-alcoholic extract every 12 hours for 8 weeks. These capsules are prepared in the Department of Medicinal Plants Pharmacology of Mashhad University of Medical Sciences. According to the studies presented on Rosa damascena mill, 71 mg / kg per day of the alcoholic extract of this plant will not be toxic to humans. Control group: In this group, research units take a placebo capsule every 12 hours for 8 weeks. Each of these capsules contains 500 mg of Avisel powder and is made with the appearance and packaging similar to Rosa damascena capsule in the Department of Medicinal Plants of Mashhad University of Medical Sciences. Severity of menopause symptoms. Timepoint: At the beginning of the study (before the start of the study) and at the beginning of weeks 4 and 8 after the start of the study. Method of measurement: Menopause raring scale. Depression, anxiety and stress in menopausal women. Timepoint: At the beginning of the study (before the start of the study) and at the beginning of weeks 4 and 8 after the start of the study. Method of measurement: Depression, Anxiety and Stress Scale. Quality of sleep in menopausal women. Timepoint: At the beginning of the study (before the start of the study) and at the beginning of weeks 4 and 8 after the start of the study. Method of measurement: Pittsburgh Sleep Quality Index. Sexual function in menopausal women. Timepoint: At the beginning of the study (before the start of the study) and at the beginning of weeks 4 and 8 after the start of the study. Method of measurement: Female sexual function index. Mashhad University of Medical Sciences Approved 2021-02-13 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)