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IRCT138711201548N2 IRCT 2009-09-09 Deputy for Research of Shiraz University of Medical Sciences Comparison of the effect of dydrogesterone and calcium plus vitamin D on the severity of premenstrual syndrome The effect of treatment with dydrogesterone or calcium plus vitamin D on the severity of premenstrual syndrome 2008-02-03 anticipated 180 Complete https://irct.ir/trial/833 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 3 Severity of premenstrual syndrome. Intervention 1: Dydrogesterone,twice daily from the 15th to the 24th day of the menstrual cycle. Intervention 2: Calcium D, twice daily from the 15th to the 24th day of the cycle. Intervention 3: Placebo: twice daily from the 15th to the 24th day of the cycle.
public
scientific Khadijeh Abdali
Namazi Sq.
Shiraz Iran (Islamic Republic of) +98 71164742528 abdalikh@sums.ac.ir Fatemeh College of Nursing and Midwifery, Shiraz Iran (Islamic Republic of) Inclusion criteria: (1) having regular menstrual cycles (3–8 days of menstruation between intervals of 22–35 days); (2) not taking medications such as hormonal contraceptives, antipsychotics, or vitamins; (3) not having contraindications to taking dydrogesterone or supplements containing calcium or vitamin D; (4) meeting the American College of Obstetrics and Gynecology and American Psychiatric Association standard diagnostic criteria for PMS (5 or more symptoms present for most of the time during the 7–10 days prior to menstruation; symptoms beginning to remit a few days after the onset of the follicular phase and absent in the week following the menses; and at least 1 symptom in the psychotic domain); (5) diagnostic criteria confirmed by prospective daily symptom ratings during at least 2 consecutive cycles; (6) symptoms markedly interfering with work or school activities and relationships; (7) symptoms not merely an exacerbation of another condition such as epilepsy or a major depressive disorder, panic disorder, or personality disorder; and (8) not using daily foods containing a great deal of calcium and/or vitamin D. 18 years 26 years Female N94 Pain and other conditions associated with female genital organs and menstrual cycle Treatment - Drugs Treatment - Drugs Placebo Dydrogesterone,twice daily from the 15th to the 24th day of the menstrual cycle Calcium D, twice daily from the 15th to the 24th day of the cycle Placebo: twice daily from the 15th to the 24th day of the cycle Severity of premenstrual syndrome. Timepoint: one month. Method of measurement: Daily symptom rating questionnaire. Decrease in the severity of premenstrula syndrome. Timepoint: one month. Method of measurement: questionnaire of daily symptom rating. Deputy for Research of Shiraz University of Medical Sciences Approved 2008-02-03 Medical Research Ethics Committee of Shiraz University of Medical Sciences Zand St. Shiraz Iran (Islamic Republic of)