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IRCT2017011131880N1 IRCT 2017-01-24 Vice chancellor for research, Iran University of Medical Sciences The Comparison of the Effect of Omega3 and Folic Acid Oral Tablet on Hot Flashes in Menopausal Women The Comparison of the Effect of Omega3 and Folic Acid Oral Tablet on Hot Flashes in Menopausal Women 2016-11-21 anticipated 120 Complete https://irct.ir/trial/24969 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization: Sample allocation in the case and control group will be conducted randomly and using lottery through numbering 1, 2 and 3 on the cards. The samples will be asked to pick a card. By choosing a card, randomly the sample will be placed in one of the following groups: Group Evening omega3 (1 tablet 1000 mg daily), folic acid (1 tablet 1 mg daily) and placebo groups (1 capsules daily) Blinding:the medicine( omega3 and folic acid) and placebo in the form of similar tablet will be produced by pharmacology advisor. Also putting capsules in the same containers and coding them will be performed by him. And at the end of the study and after analyzing the results, the tablet containers will be decoded. Thus, the samples are not aware of the contents of the medicine containers. As well as researchers and statistical analysts are not aware of the contents of the medicine containers and each groups What medications are taking. So, the study is a triple-blind. N/A menopause. Intervention 1: Intervention group:omega3 1 tablet 1000 mg daily, group folic acid 1 tablet 1 mg daily،omega3 is made zahravi , folic acid made Shahid Beheshti University of Medical Science in the School of Pharmacy. Intervention 2: Control group: placebo 1 tablet daily for 3 months , made School of Pharmacy Shahid, Beheshti University of Medical Sciences.
public masoumeh chamani
School of Nursing and Midwifery, Yasemi Rashid Street, Valiasr Street, Tehran
tehran Iran (Islamic Republic of) 1996713883 +98 21 8888 2885 m66.chamani@gmail.comchamani.m@tak.iums.ac.ir Iran University of Medical Sciences, School of Nursing and Midwifery scientific Fereshteh Jahdi
School of Nursing and Midwifery, Yasemi Rashid Street, Valiasr Street, Tehran
tehran Iran (Islamic Republic of) 1996713883 +98 21 8888 2885 jahdi_fr@yahoo.com University of Medical Sciences Iran, School of Nursing and Midwifery Iran (Islamic Republic of) Inclusion criteria : Iranian, age 45-60 years, menopause is the normal type have,reporting at least two times hot flashes per day , with literacy being studied components or a family member, body mass index 20 to 30, non receiving hormone therapy , anti-depressants or tranquilizers, supplements and herbal medicines, no known underlying disease (hypertension, diabetes, epilepsy, etc.), the lack of experience of such as relatives died in the last 6 months of stress, separation of spouses and absence of estrogen-dependent cancer, non consumption of more than 2 servings of fish per weeks, insensitivity to fish or fish oil, seafood, avoiding the use of any drugs to improve the symptoms of hot flashes, at least one year and a maximum of three years have menstruation, exercise not more than 2 times a week for 20-30Dqyqh,Exclusion criteria: the other drug use during the study, in case of complications or allergic drugs (omega-3 or folic acid), identifying any physical or mental illness during the study, lack of proper use of drugs or placebo over three days 45 years 60 years Female N95.1 Menopausal and female climacteric states Placebo Placebo Intervention group:omega3 1 tablet 1000 mg daily, group folic acid 1 tablet 1 mg daily،omega3 is made zahravi , folic acid made Shahid Beheshti University of Medical Science in the School of Pharmacy Control group: placebo 1 tablet daily for 3 months , made School of Pharmacy Shahid, Beheshti University of Medical Sciences The severity of hot flashes. Timepoint: Before the intervention, one month and two months and three months after intervention. Method of measurement: Daily hot flash diary form. Duration of hot flashes. Timepoint: Before the intervention, one month and two months and three months after intervention. Method of measurement: Daily hot flash diary form. Frequency hot flashes. Timepoint: Before the intervention, one month and two months and three months after intervention. Method of measurement: Daily hot flash diary form. Vice chancellor for research, Iran University of Medical Sciences Approved 2016-08-08 Iran University of Medical Sciences School of Nursing and Midwifery, Yasemi Rashid Street, Valiasr Street, Tehran tehran Iran (Islamic Republic of)