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IRCT20201027049164N3 IRCT 2021-10-07 Kerman University of Medical Sciences Comparative investigation between the effectiveness of Salvia officinalis extract and Cognitive remediation therapy on cognitive function in menopausal women Comparative investigation between the effectiveness of Salvia officinalis extract and Cognitive remediation therapy on cognitive function in menopausal women 2021-11-22 anticipated 90 Complete https://irct.ir/trial/59014 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In order to randomize the selection, numbers from 1 to 90 will be allocated to the participants, respectively, then using the random block allocation method with six blocks, individuals will be divided into three groups of 30. How to place people in each of the counseling groups and sage extract and control will be random, which will be done using online software to generate random sequences (www.randomizer.org/). In order to hide the process of random allocation and prevent bias, the selection of this action will be done after the final list is prepared by a person other than the main researcher and the researcher will be obliged to act exactly accordingly. N/A cognitive function impairment. Intervention 1: Intervention group 1:The counseling group will receive 8 sessions of 90 minutes, one session per week as a group of cognitive rehabilitation counseling. Intervention 2: Intervention group 2 : Sage extract tablets will be given in variable doses that follow the estrogen pattern of the menstrual cycle. Thus, at the beginning of the menstrual cycle, estrogen is low, and then, as the menstrual cycle gradually increases, the dose of sage tablets increases. The maximum dose of the pill is given on the fourteenth day according to the peak of estrogen in the normal cycle, then, as in the normal cycle, when the amount of estrogen decreases, the dose of sage pill also decreases. That is, we will start the dose of the drug from 70 mg twice a day, and until the fourteenth day, we will add 10 mg every day, and on the fourteenth day, we will have the highest dose, ie 200 mg, and again we will have a 14-day reduction process. Intervention 3: Control group: They will only receive routine clinic interventions and will not receive any other 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 Its release schedule is not yet known
public Mohadese Yazdani
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 76169-13555 +98 34 3132 5700 mohadese.yzd22@gmail.com Kerman University of Medical Sciences scientific Masumeh Ghazanfarpour
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5856 M.ghazanfarpour@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Iranian women 45 to 65 years old Cutting menstruation for at least one year Minimum literacy reading and writing Lack of sensitivity to herbal medicines No addiction or smoking Lack of any known physical illnesses such as epilepsy and vascular and renal and liver diseases Lack of any significant psychiatric disorders of anxiety and depression and significant psychiatric neurological symptoms Do not use any drugs that affect memory and cognitive function Having a personal desire and conscious satisfaction to participate in the study Do not take any phytoestrogen herbal medicine for three months before the intervention No infection or no history of breast or vaginal cancer Absence of severe cognitive disorders (Alzheimer's and dementia) 45 years 65 years Female Symptoms of drug allergy Taking any medication while conducting research Existence of severe stress during treatment Absence of more than two sessions in counseling sessions Has taken less than 85% of the drug Acute and chronic diseases infection during the study G31.84 Mild cognitive impairment, so stated Treatment - Other Treatment - Drugs Other Intervention group 1:The counseling group will receive 8 sessions of 90 minutes, one session per week as a group of cognitive rehabilitation counseling. Intervention group 2 : Sage extract tablets will be given in variable doses that follow the estrogen pattern of the menstrual cycle. Thus, at the beginning of the menstrual cycle, estrogen is low, and then, as the menstrual cycle gradually increases, the dose of sage tablets increases. The maximum dose of the pill is given on the fourteenth day according to the peak of estrogen in the normal cycle, then, as in the normal cycle, when the amount of estrogen decreases, the dose of sage pill also decreases. That is, we will start the dose of the drug from 70 mg twice a day, and until the fourteenth day, we will add 10 mg every day, and on the fourteenth day, we will have the highest dose, ie 200 mg, and again we will have a 14-day reduction process. Control group: They will only receive routine clinic interventions and will not receive any other intervention. Cognitive function. Timepoint: Beginning of the study (before the start of the intervention) and end of the intervention. Method of measurement: Montreal Cognitive Assessment Questionnaire (MOCA). Kerman University of Medical Sciences Approved 2021-09-29 Ethics committee of Kerman University of Medical Sciences Deputy of Research and Technology;ebne-e-Sina St.,Jahad Blvd., Kerman,Iran Kerman Kerman Iran (Islamic Republic of)