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IRCT20220102053592N1 IRCT 2022-06-18 Mashhad University of Medical Sciences the effect of Heracleum persicumon hot flashes the effect of Heracleum persicum hydroalcoholic extract on hot flashes in menopausal women 2022-07-01 anticipated 80 Complete https://irct.ir/trial/63460 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block stratified random allocation is used. In the first stage, based on the BMI index, the samples are placed in three classes: BMI≥30, BMI = 25-29.9 and BMI <25. Then, inside the classes, the samples are assigned to research groups A or B by randomly allocating blocks with quadruple blocks using PASS statistical software. To hide the allocation, sealed envelopes are numbered in order. This form is opened according to the order of entry of eligible participants to study the relevant envelope and the assigned group of the participant is revealed, Blinding description: This study is triple blind; This means that the participant, researcher and outcome evaluator and data analyst are unaware of the allocation of study groups and the same capsules in terms of color, odor and shape for both groups (drug and placebo) in the same box with a code label. (A and B coded by the pharmacologist) are used. 3 Hot flashes. Intervention 1: Intervention group: To the intervention group, capsules containing 500 mg of hydroalcoholic extract of Angelica baccarat Herbarium E1259-FUMH, prepared in the laboratory of Mashhad School of Traditional Medicine, are given one orally daily for 4 weeks. Intervention 2: Control group: To the control group, capsules containing 500 mg of oral Avisel powder prepared in the laboratory of Mashhad School of Traditional Medicine will be given as one drop orally daily for 4 weeks. 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 Faezeh Shajieej
School of Nursing and Midwifery, Ibn Sina St, Doctora Crossroads, Mashhad, Khorasan Razavi
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 shajieejf981@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Mahboubeh Firoozi
School of Nursing and Midwifery, Ibn Sina St, Doctora Crossroads, Mashhad, Khorasan Razavi
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 firoozimah@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Iranian and resident of Mashhad Literacy for reading and writing Phone number to call At least 12 months after the last normal menstruation or FSH> 40 and a maximum of one year after the last normal menstruation Healthy Pap smear: if the Pap smear is Liquid based from 5 years ago and the traditional Pap smear is from 3 years ago Complaints of hot flashes: on average during 2 weeks of screening, having moderate or severe hot flashes 5 or more times a day Not receiving estrogen or progesterone for the past three months No spotting in the past year Do not use tobacco (cigarettes, hookah and drugs) and alcohol No tragic events in life in the last 6 months: Death of spouse, children or close family members, severe illness of family members, major change in employment and life, dismissal or unemployment of self or spouse Severe family dispute or divorce Do not use medications to reduce the symptoms of hot flashes for the past 1 month: Hormonal contraceptives, venlafaxine, paroxytin, fluoxetine, gabapentin, clonidine, vitamin E supplements, bromocriptine, oral naloxone, veralipride, yoga, acupuncture, citalopram, sertraline, pre-gabapentin, relaxation techniques No chronic diseases: Cardiovascular, liver disorders, skin diseases, thyroid disorders Lack of sensitivity to Heracleum persicum: Includes any changes and skin allergies and sensitivity to sunlight Do not use medicinal plants containing phytoestrogens: including soybeans, flaxseed, licorice, fenugreek, fennel, hops, sage, red clover, black cohosh 40 years no limit Female Major changes in nutrition and physical activity patterns: Starting exercise programs Use of medicinal plants containing phytoestrogens during the study: including soybeans, flaxseed, licorice, fenugreek, fennel, hops, sage, red clover, black cohosh use medications to reduce the symptoms of hot flashes for the past 1 month: Hormonal contraceptives, venlafaxine, paroxytin, fluoxetine, gabapentin, clonidine, vitamin E supplements, bromocriptine, oral naloxone, veralipride, yoga, acupuncture, citalopram, sertraline, pre-gabapentin, relaxation techniques Do not fill out the hot flush questionnaire for 3 days or more in a week Do not take the drug for 2 days or more Occurrence of symptoms of allergy to heracleum persicum during the study: includes any changes and skin sensitivity and sensitivity to sunlight, including any changes and skin sensitivity and sensitivity to sunlight N95.1 Menopausal and female climacteric states Treatment - Drugs Placebo Intervention group: To the intervention group, capsules containing 500 mg of hydroalcoholic extract of Angelica baccarat Herbarium E1259-FUMH, prepared in the laboratory of Mashhad School of Traditional Medicine, are given one orally daily for 4 weeks. Control group: To the control group, capsules containing 500 mg of oral Avisel powder prepared in the laboratory of Mashhad School of Traditional Medicine will be given as one drop orally daily for 4 weeks. Duration of hot flashes. Timepoint: At the beginning of the study and 2 and 4 weeks after the intervention. Method of measurement: Daily hot flush registration form. Intensity of hot flashes. Timepoint: At the beginning of the study and 2 and 4 weeks after the intervention. Method of measurement: Daily hot flush registration form. Frequent flushing. Timepoint: At the beginning of the study and 2 and 4 weeks after the intervention. Method of measurement: Daily hot flush registration form. Intensity of night sweats. Timepoint: At the beginning of the study and 2 and 4 weeks after the intervention. Method of measurement: Night sweat registration form. Frequent night sweats. Timepoint: At the beginning of the study and 2 and 4 weeks after the intervention. Method of measurement: Night sweat registration form. Mashhad University of Medical Sciences Approved 2022-04-16 Ethics Committee of Mashhad University of Medical Sciences University Street, Mashhad, Khrasan Razavi Mashhad Razavi Khorasan Iran (Islamic Republic of)