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IRCT201604193924N3 IRCT 2017-03-10 Vice chancllor for Isfahan University of Medical Sciences Clinical trial of comparison of effectiveness of Omega-3 supplement on PCOS and metabolic syndrome with placebo Comparison of effectiveness of Omega3 supplementation on poly cystic ovary syndrome(PCOs) symptoms and metabolic syndrome according of the NIH criteria 2016-05-21 anticipated 88 Complete https://irct.ir/trial/4078 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: patient will take closed pocket and drug store dependent on number (single or pair) will give drug or placebo. 3 Condition 1: Polycystic ovarian syndrome. Condition 2: menstural disorder. Condition 3: metabolic syndrom. Condition 4: hyperandrogenism. Condition 5: hirsutism. Intervention 1: intervention group : gives Omega 3 supplementation for 6 mounts. Intervention 2: control group : gives 2 placebo capsule daily for 6 mounts.
public Dr. Sajedhe Jafari
Isfahan
Isfahan Iran (Islamic Republic of) 73461-81746 +98 913 368 1360 hb32us@yahoo.com Isfahan University of Medical Siencese scientific Dr. Behnaz Khani
Department of Obstetrics , School of Medicine , Isfahan University of Medical Sciences, Isfahan , Islamic Republic Of Iran 73461-81746 00983136687898
Isfahan Iran (Islamic Republic of) 73461-81746 +98 31 3668 7898 khani@med.mui.ac.ir Isfahan University of Medical Siencese Iran (Islamic Republic of) Iran (Islamic Republic of) inclusion criteria: Patients who have informed consent ; PCOS disease, according to the NIH3 ; age between 18-40 ; Exclusion criteria: smoking, use of oral pregnancy pill or alcohol or fish oil in 3 month ago or into the study ; pregnancy; have disease of kidney or liver or heart or thyroid ; diabetes ; hyperprolactinemia ; Cushing, Adrenal congenital hyperplasia, menopause ; the patient withdrew into the study ; Failure to follow the next visit 18 years 40 years Female E28.2 n92.6 , n9 E88.9 E28.1 L68.0 Sclerocystic ovary syndrome Stein-Leventhal syndrome hypomenorrea Nos, bleeding NOs, periods NOS metabolic disorder unspecified hyper secretion of ovarian androgen genital hair exess in female Treatment - Drugs Treatment - Drugs intervention group : gives Omega 3 supplementation for 6 mounts. control group : gives 2 placebo capsule daily for 6 mounts Menstrual disorders. Timepoint: 6 mounth afther implementation study. Method of measurement: questionnaire of Bleeding volume, number of days of spotting, Menstrual periods. Body mass index. Timepoint: 6 mounth afther implementation study. Method of measurement: Weight in kilograms divided by the square of height in meters. Hirsutism. Timepoint: 6 mounth afther implementation study. Method of measurement: Ferrimen- Gullway score. Abdominal circumference. Timepoint: and 6 mounths after implemention of study. Method of measurement: The size of the margin around the narrowest part of the lower ribs and the iliac crest at the end of a normal exhalation. Hip circumference. Timepoint: 6 mounths after implemention of study. Method of measurement: Hip circumference on the line that connects the two greater trochanter. Fasting blood sugare. Timepoint: 6 mounths after implemention of study. Method of measurement: blood glucose levels after 8 hours fasting. Vice chancllor for Isfahan University of Medical Sciences Approved 2015-01-28 Ethics committee of Isfahan university of medical siences isfahan, Hezar jerib avenue, Isfahan university of medical siences Isfahan Iran (Islamic Republic of)