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IRCT20200925048838N1 IRCT 2020-10-12 Ahvaz University of Medical Sciences The effect of borage tea on sleep disorders in postmenopausal women The effect of borage tea on sleep disorders in postmenopausal women 2020-11-10 anticipated 60 Complete https://irct.ir/trial/51393 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is performed using a random number table to create quadruple blocks in a one-to-one ratio that will be placed in two groups of 30 people to intervene and control, Blinding description: In this study, according to the apparent simulation in prescription tea and the use of a cup of the same size for similarity of the concentration of the substance in the two groups, the researcher and the participants do not know each person is in which group. 3 sleep disorders in postmenopausal women.. Intervention 1: Intervention group: For this patient, if they have the inclusion criteria, after providing explanations about the dissertation plan and obtaining informed consent; before the intervention, the demographic information form, PSQL questionnaire and ISI questionnaire will be completed. 2-grams of borage tea is applied every night before going to bed for 8 weeks. a cup of the same size is purchased and given to all intervention groups to determine the same concentration. 8 weeks after the intervention, the questionnaires will be completed again by all subjects. Intervention 2: Control group: For this patient, if they have the inclusion criteria, after providing explanations about the dissertation plan and obtaining informed consent; before the intervention, the demographic information form, PSQL questionnaire and ISI questionnaire will be completed. In the control group, the intervention is applied by placebo. The placebo will also contain wheat germ powder in a 2-grams bag, which is quite similar in appearance to the bag containing 2-grams of borage tea and is given every night before bed for 8 weeks. Also, for all members of the group, a cup of the same size is purchased and given to determine the uniform concentration of the placebo. 8 weeks after the intervention, the questionnaires will be completed again by all subjects. It should be noted that the ineffectiveness of wheat germ on sleep disorders has been proven. 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 Leila Ghasemzadehdehkorde
Padadshahr 18th West Street
Ahvaz Iran (Islamic Republic of) 6395137149 +98 61 4372 2717 ghasemzadeh.L@ajums.ac.ir Ahvaz University of Medical Sciences scientific Mitra Tadayon Najafabadi
Golestan Blvd., Esfand Ave
Ahvaz Iran (Islamic Republic of) 15794- 61357 +98 61 3336 7543 tadayon-m@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Amenorrhea for at least 12 years. 60-45 years old. Score more than 5 on the Pittsburgh Questionnaire 45 years 60 years Female Occurrence of any physical or psychological disorder during the study that causes sleep disorders. Discontinuation of borage tea consumption by the subject for any reason before the end of the intervention period Having an underlying disease ( hypertension - diabetes) Use of hormone therapy. Having Chronic disease (heart, kidney, diabetes, hypertension) Consumption of alcohol and addictive substances. Having an allergy to borage Taking benzodiazepines pills during the last 3 months. G47 Sleep disorders Treatment - Other Treatment - Other Intervention group: For this patient, if they have the inclusion criteria, after providing explanations about the dissertation plan and obtaining informed consent; before the intervention, the demographic information form, PSQL questionnaire and ISI questionnaire will be completed. 2-grams of borage tea is applied every night before going to bed for 8 weeks. a cup of the same size is purchased and given to all intervention groups to determine the same concentration. 8 weeks after the intervention, the questionnaires will be completed again by all subjects. Control group: For this patient, if they have the inclusion criteria, after providing explanations about the dissertation plan and obtaining informed consent; before the intervention, the demographic information form, PSQL questionnaire and ISI questionnaire will be completed. In the control group, the intervention is applied by placebo. The placebo will also contain wheat germ powder in a 2-grams bag, which is quite similar in appearance to the bag containing 2-grams of borage tea and is given every night before bed for 8 weeks. Also, for all members of the group, a cup of the same size is purchased and given to determine the uniform concentration of the placebo. 8 weeks after the intervention, the questionnaires will be completed again by all subjects. It should be noted that the ineffectiveness of wheat germ on sleep disorders has been proven. Sleep disorder in postmenopausal women. Timepoint: Pre-intervention, 8 weeks after the start of the intervention. Method of measurement: Variables are measured by demographic questionnaire, Pittsburg Sleep Quality Index (PSQL) and Insomnia Severity Index (ISI). Sleep disorders in postmenopausal women. Timepoint: Pre-intervention, 8 weeks after the start of the intervention. Method of measurement: Variables are measured by demographic questionnaire, Pittsburg Sleep Quality Index (PSQL) and Insomnia Severity Index (ISI). Ahvaz University of Medical Sciences Approved 2019-12-09 Ethics committee of Ahvaz University of Medical Sciences Esfand Ave., Golestan Blvd., Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)