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IRCT20120718010324N44 IRCT 2018-06-23 Tabriz University of Medical Sciences The effect of curcumin and vitamin E on hot flush and anxiety in postmenopausal women The effect of oral capsule of curcumin and vitamin E on the hot flush and anxiety in postmenopausal women: a triple blind randomised controlled trial 2018-07-04 anticipated 93 Complete https://irct.ir/trial/29563 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be assigned by block randomization method with a 1: 1: 1 assignment ratio to three groups (two intervention groups and one control group), Blinding description: Participants, researcher and analyst will be completely blind in this study. The drug and the placebo will be the same in appearance (shape, color and odor), and the packaging of drugs will be done by someone who is not involved in the research. 2 Condition 1: hot flush. Condition 2: anxiety. Intervention 1: The first Intervention group will receive oral capsules of curcumin twice a day at a dose of 500 milligrams for eight weeks. Intervention 2: The second intervention group will receive oral Capsule Vitamin E 200 IU twice a day for eight weeks. Intervention 3: The control group will receive placebo capsules twice a day for 8 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Khatereh Ataei
Faculty of Nursing Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) 5155884818 +98 41 4438 8341 khaterehatayi@gmail.com Tabriz University of Medical Sciences scientific Dr. Mojgan Mirghorvand
aculty of Nursing Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 mirghafourvandm@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study Having sufficient literacy to complete the questionnaire or the presence of a literate person in the family Normal menopause Being married Women who have been under 6 years old since their menopause. Having at least 40 years and a maximum of 60 Having hot flush at least twice a week 40 years 60 years Female Use of tobacco and alcoholic beverages and herbal medicines Stressful factors such as the death of relatives in the first six months of the past and loss of occupation Known psychiatric or systemic problems including cardiovascular, digestive, liver, endocrine, etc. Use of any effective medicines for hot flashes (Clonidine, Methyl dopa, Gabapentin, Selective Serotonin Reuptake Inhibitors (SSRIs), Norepinephrine inhibitors (SNRI), and Soy isoflavone Factors that cause vasomotor disorder, such as thyroid disease, according to the person expression Use of any effective medication to treat a person's sexual response (Antihypertensive, Thiazide diuretics, Antidepressant drugs such as Serotonin and Noradrenaline and Reuptake, Antihistamines, Barbiturates, Narcotics, Diazepam, Amphetamines, Cocaine History of allergy to turmeric or other drugs, food and color Taking anticoagulant drugs (Hyarin, Warfarin, Enoxaparin) N95.1 F41.9 Menopausal and female climacteric states Anxiety disorder, unspecified Treatment - Drugs Treatment - Drugs Placebo The first Intervention group will receive oral capsules of curcumin twice a day at a dose of 500 milligrams for eight weeks The second intervention group will receive oral Capsule Vitamin E 200 IU twice a day for eight weeks. The control group will receive placebo capsules twice a day for 8 weeks Hot flush. Timepoint: Before the intervention, 4 and 8 weeks after the intervention. Method of measurement: Hot flush checklist. Anxiety. Timepoint: Before the intervention, 4 and 8 weeks after the intervention. Method of measurement: State- Trait Anxiety Inventory. Sexual function. Timepoint: Before the intervention, 4 and 8 weeks after the intervention. Method of measurement: FSFI= Female Sexual Function Inventory. Tabriz University of Medical Sciences Approved 2018-05-27 Ethics Committee of Tabriz University of Medical Sciences Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue Tabriz East Azarbaijan Iran (Islamic Republic of)