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IRCT20080902001181N4 IRCT 2023-01-21 Esfahan University of Medical Sciences Comparison of the effect of Agnugol, Cimifugol , Soyagol , vitagnus and EsCitalopram Comparison of the effect of Agnugol, Cimifugol , Soyagol , vitagnus and EsCitalopram in reducing menopausal symptoms in postmenopausal women 2023-01-07 anticipated 200 Complete https://irct.ir/trial/67507 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, 200 eligible patients will be selected non-randomly and in the order of referral. Allocation of people to the five study groups will be done by "Random Allocation" specialized software and by Simple randomization method. First, on the main page of the software, we enter the number of intervention groups (5 groups) and The name of interventions (based on the code defined for each type of intervention in advance) and the sample size (200 people). Then, by pressing the Generate random list button, a list according to the entered sample size (number 1 to 200) will be presented, which randomly specifies the type of each intervention (designated intervention code) for each person in the order of entering the study. to give Therefore, based on this list and in the order in which people enter the study, the person who distributes the drugs provides the relevant drug to the participants, Blinding description: In this study, 5 drugs "Agnugol", "Vitagnus", "soyagol", "cimifugol" and "EsCitalopram 10" are prepared and placed in coded packages and provided to the researcher. He also provides the patient without knowing the type of any medicine. Also, the patient, the person recording the clinical and basic information of the patients, as well as the statistical analyst, will not be aware of the type of intervention. 3 Menopause. Intervention 1: first intervention group: One CimiFugol coated tablet containing 6.5 mg of dry root of black cohosh plant manufactured by GolDaru Company will be taken daily for 8 weeks every night at a certain time with some water, preferably before going to bed. Intervention 2: second intervention group: One Agnugol coated tablet daily containing 4.8 mg of dry extract of the fruit of Vitex agnus-castus plant (standardized as 0.42-0.58 mg of Ecobin) manufactured by GolDaru Company for 8 weeks every night at a certain time with some water preferably before going to bed. Intervention 3: The third intervention group: once a day before meals, Vitagnus coated tablets containing Vitex agnus-castus plant (standardized as 1.2-3.3 mg of Ecobin) manufactured by Porsina Company will be consumed for 8 weeks. Intervention 4: 4th intervention group: They take one Soyagol coated tablet containing 50 mg of soy isoflavone, manufactured by GolDaru Company, for 8 weeks every night at a certain time with some water after meals. Intervention 5: The fifth intervention group: take one 10 mg Escitalopram tablet daily after lunch for 8 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mansour Siavash
Hezar Jerib Street
Isfahan Iran (Islamic Republic of) 8187698191 +98 31 3668 8138 siavash@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mansour Siavash
Khorram street, Jomhoori square
Isfahan Iran (Islamic Republic of) 8187698191 +98 31 1222 0998 siavash@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Obtaining a score of 5 and above from the MRS questionnaire 12 months or more have passed since menopause Age between 45 and 65 years 45 years 65 years Female Presence or history of breast and uterine cancer, abnormal vaginal bleeding, liver, kidney, thyroid, depression and known anxiety disorders. Use of progestins, contraceptive pills, GNRH agonists and antagonists Taking drugs that interact with the studied drugs, such as warfarin, tamoxifen, antipsychotics, and dopamine antagonists. N95.1 Menopausal and female climacteric states Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs first intervention group: One CimiFugol coated tablet containing 6.5 mg of dry root of black cohosh plant manufactured by GolDaru Company will be taken daily for 8 weeks every night at a certain time with some water, preferably before going to bed. second intervention group: One Agnugol coated tablet daily containing 4.8 mg of dry extract of the fruit of Vitex agnus-castus plant (standardized as 0.42-0.58 mg of Ecobin) manufactured by GolDaru Company for 8 weeks every night at a certain time with some water preferably before going to bed. The third intervention group: once a day before meals, Vitagnus coated tablets containing Vitex agnus-castus plant (standardized as 1.2-3.3 mg of Ecobin) manufactured by Porsina Company will be consumed for 8 weeks. 4th intervention group: They take one Soyagol coated tablet containing 50 mg of soy isoflavone, manufactured by GolDaru Company, for 8 weeks every night at a certain time with some water after meals. The fifth intervention group: take one 10 mg Escitalopram tablet daily after lunch for 8 weeks. Total score of menopausal symptoms. Timepoint: The total score of menopausal symptoms is checked at the beginning of the study (before the start of the intervention), the fourth and the eighth week after the start of the intervention. Method of measurement: Menopause Rating Scale (MRS). Esfahan University of Medical Sciences Approved 2022-04-07 Isfahan University of Medical Sciences Hezar jerib Street Isfahan Isfehan Iran (Islamic Republic of)