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IRCT20210201050212N1 IRCT 2021-07-28 Kerman University of Medical Sciences The effect of yarrow on menopause Investigation of the Comparative Effectiveness Between Achillea wilhelmsii Consumption and Counseling with Mindfulness-Based Cognitive Therapy (MBCT)ََApproach on Hot Flashes, Quality of Life and Sleep in Menopausal Women 2021-08-06 anticipated 75 Complete https://irct.ir/trial/54059 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Random permutation will be performed using the block method: For random assignment, triple blocks with three patients and a table of single-digit random numbers are used, so that for a random number, a triple block, and for a random number, two triple blocks, and so on, the numbers zero, seven, and eight are used. No, we will. ABC for digit 1 ACB for figure 2 BAC for digit 3 BCA for figure 4 CAB for digit 5 CBA for figure 6 And we ignore the numbers 0, 7, 8 and 9. The reason for using the random permutation block method is that the number of people in the groups is equal. 2 Condition 1: Investigation of the comparative effectiveness between Achillea wilhelmsii consumption and counseling with mindfulness-based cognitive therapy (MBCT) approach on hot flashes, in menopausal women. Condition 2: Comparative study of the effect of Achillea wilhelmsii and counseling with mindfulness-based cognitive therapy approach on quality of life in postmenopausal women. Condition 3: Comparative study of the effect of Achillea wilhelmsii and counseling with mindfulness-based cognitive therapy approach on sleep quality in postmenopausal women. Intervention 1: Intervention group: Achillea wilhelmsii capsule (2 mg daily in the morning and evening for 2 months) which contains Achillea wilhelmsii which has phytoestrogenic properties and is produced by Kerman School of Pharmacy. Intervention 2: Intervention group: Counseling group:Eight sessions of 120 to 150 minutes. With 45 minutes a day of exercise, which can be accompanied by a one-day program of mindfulness guided in week 6. In the first 4 sessions, the focus is on inner experiences and in the second half on the challenges of life. Mindfulness training will be short. Intervention 3: Control group: Does not receive any intervention. 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 There is no more information
public Omolbanin Lotfi
No.1,GHarani Ave,Torbat Heydariyeh University of Medical Sciences
Torbat heydarieh Iran (Islamic Republic of) 9516717311 +98 51 5222 7100 o.lotfi1398@gmail.com Kerman University of Medical Sciences scientific Omolbanin Lotfi
No.1,GHarani Ave,Torbat Heydariyeh University of Medical Sciences
Torbat heydarieh Iran (Islamic Republic of) 9516717311 +98 51 5222 7100 o.lotfi1398@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Be literate All Women are 65-45 Have at least 3- 20 hot flashes a day For one year after the last menstrual period 45 years 65 years Female Absence from two sessions of medical counseling Have a physical or mental illness Have a regular exercise program Taking psychotropic drugs Have a severely stressful event over the past month Has taken less than 80% of his medication Has used soy or phytoestrogens more than once in the past week Over the past week with a specific illness that is severely stressful or causing pain During the study, he had to use a special medication that caused sleep disturbances as well as hot flashes Have changed your sleeping place and place during the last week Used sleeping pills or hypnotics He has used psychedelic, sedative and anti-anxiety drugs Be addicted to drugs such as cigarettes and alcohol Use medications that cause sleep disturbances or insomnia History of yarrow or any of its components, people with allergic asthma, seizures, liver disease or cancer Take any estrogen-based medication to treat menopausal complications (osteoporosis, hot flashes) or other interfering medications such as tibolone with a night shift job. Menopause due to bilateral removal of the ovaries or undergoing chemotherapy Treatment for mental disorders or hot flashes in the last 60 days Hormone Therapy Use of hormonal contraceptives Taking selective estrogen receptor modulators or aromatase inhibitors over the past two months Have severe depression Have a severe current illness Suicide attempt in the last 3 weeks Having bipolar disorder or other mental disorders throughout life Uncontrolled blood pressure Taking tamoxifen, raloxifene, antidepressant, clonidine in the last two months Lifestyle Behavior N/A Intervention group: Achillea wilhelmsii capsule (2 mg daily in the morning and evening for 2 months) which contains Achillea wilhelmsii which has phytoestrogenic properties and is produced by Kerman School of Pharmacy Intervention group: Counseling group:Eight sessions of 120 to 150 minutes. With 45 minutes a day of exercise, which can be accompanied by a one-day program of mindfulness guided in week 6. In the first 4 sessions, the focus is on inner experiences and in the second half on the challenges of life. Mindfulness training will be short. Control group: Does not receive any intervention Flush score. Timepoint: Measure hot flashes before the study and at the end of the first and second months. Method of measurement: Flushing severity questionnaire. Kerman University of Medical Sciences Approved 2021-06-14 Ethics committee of Kerman University of Medical Sciences No.9,Kashini Ave Totbat e heydarieh Razavi Khorasan Iran (Islamic Republic of)