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IRCT20190305042936N1 IRCT 2019-07-28 Shahid Beheshti University of Medical Sciences The effect of Rose (Rosa damascena) Capsule on the Severity of Depression and Anxiety in Menopausal Women The effect of Rose (Rosa damascena) Capsule on the Severity of Depression and Anxiety in Menopausal Women 2019-08-23 anticipated 110 Complete https://irct.ir/trial/39087 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Among the health centers affiliated to Shahid Beheshti University of Medical Sciences who are most referred to, two centers will be randomly selected. 110 people (55 in the intervention group and 55 in the control group) will be selected. In order to blow up the medicine, the rose capsule in the envelope will be placed adjacent to the placebo to relieve the scent of the roses to the placebo capsule. The investigator and the research units are not aware of the coding and the fact that each envelope contains any drug. Using a simple random sampling method by throwing a coin, a sealed envelope containing the drug will be assigned to one of the centers and another sealed envelope containing the placebo to the next center. Postmenopausal women, as a research sample, will be in one of the relevant groups, Blinding description: In order to blow up the medicine, the capsule of rose in the envelope will be placed in the immediate vicinity of the placebo to transfer some of the rosy smell to the placebo capsule. The drugs are encoded in the pharmacy department of Shahid Beheshti University of Medical Sciences. The researcher and the research units are not aware of the coding and the fact that each envelope contains the drug, and only the pharmacist advised of the encoding of the envelopes and the type of medication. 3 Condition 1: ِDepression. Condition 2: Anxiety. Intervention 1: "Intervention group:" Menopausal women aged between 45-60 years old referred to Shahid Beheshti University of Medical Sciences, who received 1000 mg (two 500 mg capsules of rose, containing 500 mg of powdered dried rice with active ingredient (citronella) Vengerinol) take daily, twice, every 12 hours, in the morning and night after a meal for 40 days. "Control group: Menopausal women aged between 45-60 years old referring to Shahid Beheshti University of Medical Sciences 1000 mg (Two 500 mg starch capsules) every 12 hours, twice daily, morning and evening, after eating for 40 days. Capsules at the School of Pharmacy, University of Medical Sciences When is the martyr Beheshti prepared. Intervention 2: Control group: Menopausal women aged between 45-60 years old referring to Shahid Beheshti University of Medical Sciences 1000 mg (Two 500 mg starch capsules) every 12 hours, twice daily, morning and evening, after eating for 40 days. Capsules at the School of Pharmacy, University of Medical Sciences When is the martyr Beheshti prepared. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information.
public Qamar Riazi
Shahid Beheshti University of Medical Science-Valiasr St
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 riazi.qamar2430@gmail.com Shahid Beheshti University of Medical Sciences scientific Masoumeh Simbar
Shahid Beheshti University of Medical Science-Valiasr St
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 msimbar@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Menopausal women aged 45-60 years Having normal blood pressure Not having a historyof BreastCancer, uterine, endometrial hyperplasia, abnormal vaginal bleeding, liver disease, hyperthyroidism Not having a history of hysterectomy or ovariectomy Not having physical (Diabet) or psychiatric illnesses Do not use rose or dried rose extract 45 years 60 years Female Sensitization to herbal medicines Smoking and Alcohol F32.9 F06.4 Depressive episode , unspecifide Anxiety disorder due to known physiological condition Treatment - Drugs Treatment - Drugs "Intervention group:" Menopausal women aged between 45-60 years old referred to Shahid Beheshti University of Medical Sciences, who received 1000 mg (two 500 mg capsules of rose, containing 500 mg of powdered dried rice with active ingredient (citronella) Vengerinol) take daily, twice, every 12 hours, in the morning and night after a meal for 40 days. "Control group: Menopausal women aged between 45-60 years old referring to Shahid Beheshti University of Medical Sciences 1000 mg (Two 500 mg starch capsules) every 12 hours, twice daily, morning and evening, after eating for 40 days. Capsules at the School of Pharmacy, University of Medical Sciences When is the martyr Beheshti prepared. Control group: Menopausal women aged between 45-60 years old referring to Shahid Beheshti University of Medical Sciences 1000 mg (Two 500 mg starch capsules) every 12 hours, twice daily, morning and evening, after eating for 40 days. Capsules at the School of Pharmacy, University of Medical Sciences When is the martyr Beheshti prepared. Depression Score in Beck Questionnaire. Timepoint: Before the start of the study, 20 days later, 40 days later. Method of measurement: Beck questionnaire. Anxiety Scale in the Spielberg Burner Questionnaire. Timepoint: Before the start of the study, 20 days later, 40 days later. Method of measurement: Spielberger questionnaire. Quality score. Timepoint: At the beginning of the study, 20 days later, 40 days after starting the dose. Method of measurement: Quality of Life questionnaire. Shahid Beheshti University of Medical Sciences Approved 2019-04-15 Ethics Committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Valiasr Street Tehran Tehran Iran (Islamic Republic of)