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IRCT20180705040349N1 IRCT 2018-10-09 Tehran University of Medical Sciences The efficacy of Jazar capsule, on menopausal symptoms and sexual disorder of menopausal women The efficacy of Jazar capsule, a Persian medicine product, on menopausal symptoms and sexual disorder of menopausal women 2018-08-23 anticipated 90 Complete https://irct.ir/trial/32481 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Assignment of patients to study groups is done using Block Randomization method. Samples are divided into intervention and placebo groups based on the random sequence generated by the statistic consultant. A random sequence is generated by random four-way blocks; each block represents four participants. Distribution of placebo and interventions in each block is random but under a condition that there must be two placebos and two interventions in each block. Using this method, the number of samples assigned to each of the groups are equal, so in cases that mid-term analysis is required, the equal number of samples for both groups are available, Blinding description: Medication and placebo are identical in terms of appearance an packaging, only differentiated through the proprietary codes set by the pharmacist on the box of medicine. The patient and the prescribing researcher are not aware of the code. The outcomes of the study are prepared by the researcher who is unaware of the grouping and is blind to the groups and type of medications. 3 Menopausal symptoms and sexual disorder of menopausal women. Intervention 1: Intervention group: Jazar capsule 500mg, made by Talaye sabz Tooba company, Including powder of chastetree seeds, fennel seeds and carrot seeds, two capsules in the morning and two at night, after meals, for 8 weeks. Intervention 2: Control group: 500mg starch capsule, made by Talaye sabz Tooba company, two capsules in the morning and two at night, after meals, for 8 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 It depends on results of research
public Sousan Hafizi Moori
No. 27 , North Sarparast, West Taleghani
Tehran Iran (Islamic Republic of) 1465837744 +98 21 8897 6527 sou_hafizi@yahoo.com Tehran University of Medical Sciences scientific Sousan Hafizi Moori
Ahmadieh clinic, No, 27, Sarparast st., west Taleghani st.
Tehran Iran (Islamic Republic of) 1465837744 +98 21 8897 6527 sou_hafizi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Married women that their spouses are present at home at least for half of each month Age between 45-60 No menstrual periods for at least 12 months and no longer than 5 years literate or having a literate person at home Menopause but not due to illness or uterus and ovaries resection At least 2 hot flashes per day FSFI ≤ 26 Willing to attend the project Normal Pap smear during the last two years 45 years 60 years Female Sensitivity to the medicine or placebo Use of other medications or other therapies to reduce the menopausal symptoms during the study Hormone intake for the past 6 months Diabetes or other serious illnesses Malignancy history Addiction to cigarettes, drugs or alcohol History of mental illness N95.1 Menopausal and female climacteric states Treatment - Drugs Treatment - Drugs Intervention group: Jazar capsule 500mg, made by Talaye sabz Tooba company, Including powder of chastetree seeds, fennel seeds and carrot seeds, two capsules in the morning and two at night, after meals, for 8 weeks. Control group: 500mg starch capsule, made by Talaye sabz Tooba company, two capsules in the morning and two at night, after meals, for 8 weeks. Quality of life. Timepoint: Weeks 4, 8 and 10 after intervention. Method of measurement: Menopause quality of life questionnaire (MENQOL questionare). Sexual function. Timepoint: Weeks 4, 8 and 10th after intervention beginning. Method of measurement: Female sexual function index questionare (FSFI questionare). Vaginal maturation index (VMI). Timepoint: Before intervention and 10 weeks after intervention beginning. Method of measurement: Pap smear. Vaginal PH. Timepoint: Before intervention and 10 weeks after intervention beginning. Method of measurement: PH-meter strip. Tehran University of Medical Sciences Approved 2018-07-04 Vice-Chancellor in Research Affairs-Tehran University of Medical Sciences No.14, st 9, South Golestan, Shahrak-e-gharb Tehran Tehran Iran (Islamic Republic of) Approved 2018-07-04 Vice-Chancellor in Research Affairs-Tehran University of Medical Sciences No.14, Str 9, South Golestan , Shahrak-e-gharb Tehran Tehran Iran (Islamic Republic of)