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IRCT201508268801N20 IRCT 2016-05-30 Shahid Beheshti University of Medical Sciences Evaluation the effect of salvia officinalis on premenstrual syndrome PMS (premenstrual syndrome) Evaluation the effect of salvia officinalis on the Symptoms of Premenstrual Syndrome in the Dormitories Students of Shahid Beheshti University of Medical Science and Health Services 2015-09-11 anticipated 90 Complete https://irct.ir/trial/9292 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2-3 Premenstrual syndrome. Intervention 1: Salvia officinalis extract, 500 mg capsule oral, 21st day till the 5th day of next cycle one capsule daily. Intervention 2: Placebo, 500 mg capsule oral, 21st day till the 5th day of next cycle one capsule daily.
public Roghayeh Abdnezhad
tehran.Saadat Abad,Sarv intersection,Riazi Bakhshayesh Street, Ghaem Alley,No 19, third floor
Tehran Iran (Islamic Republic of) 1998897756 +98 21 2206 5410 gilda_9a@yahoo.comgilda.9a@gmail.com Medical Sciences University of Shahid Beheshti scientific Masoumeh Simbar
Nursing and Midwifery faculty of Shahid Behshti, Research Department
Tehran Iran (Islamic Republic of) +98 21 8820 2517 msimbar@yahoo.com Medical Sciences University of Shahid Beheshti Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: being single; age between 18-35 years old; normal body mass index; regular menstrual cycle (21-35 days), with diagnosed PMS; no physical or psychological ill conditions; not on medication (hormonal, vitamins, herbal, antidepressant, aspirin, or warfarin); no history of allergy to herbal drugs; no sad event occurrence; no surgical operation during the last six months; not being a professional athlete; presence of at least five symptoms based on DSM-IV (Diagnostic and Statistical Manual of Mental Disorders-fourth edition) for PMS diagnosis with confirmed one symptom out of the first four symptoms including (1. Feeling sad, hopeless or selfdeprecating, 2. Feeling tense, anxious, or “on edge”, 3. Marked liability of mood, interspersed with frequent tearfulness, 4. Persistent irritability, anger and increased interpersonal conflicts, 5. Decreased interest in usual activities that may be associated with withdrawal from social relationships); not being depressed based on Beck questionnaire. Those with the above mentioned criteria were entered into the study. An informed written consent was also given by each participant. Exclusion criteria: allergy to drugs; improper use of capsules and developing a significant disease and taking medications during the study. 18 years 35 years Female N94.3 Pain and other conditions associated with female genital organs and menstrual cycle Treatment - Drugs Placebo Salvia officinalis extract, 500 mg capsule oral, 21st day till the 5th day of next cycle one capsule daily Placebo, 500 mg capsule oral, 21st day till the 5th day of next cycle one capsule daily The severity of physical symptoms of premenstrual syndrome. Timepoint: Pre intervention, first month after intervention, second month after intervention. Method of measurement: Form a provisional dignosis of premenstrual syndrome from DSM5. The severity of psychological symptoms of premenstrual syndrome. Timepoint: Pre intervention, first month after intervention, second month after intervention. Method of measurement: Daily form of severity of premenstrual syndrome. The severity of symptoms of premenstrual syndrome. Timepoint: Pre intervention, first month after intervention, second month after intervention. Method of measurement: Daily form of severity of premenstrual syndrome. Side effects. Timepoint: First month after intervention, second month after intervention. Method of measurement: Questionnaire of effects and side effects of medication. Shahid Beheshti University of Medical Sciences Approved 2015-11-01 Ethical commitee of Shahid Beheshti University of Medical Sciences Medical Sciences University of Shahid Beheshti Nursing and Midwifery faculty of Shahid Behshti, Vali Asr intersection prayer in front of the Rajai Hospital Beheshti Department of Nursing and Midwifery Tehran Iran (Islamic Republic of)