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IRCT201706065623N118 IRCT 2017-07-04 Vice chancellor for research, Arak University of Medical Sciences Effect of supplementation in treatment of women with polycystic ovary syndrome Clinical trial of the effect of inofolic supplementation compared with metformin on parameters of mental health and oxidative stress in women with polycystic ovary syndrome 2016-06-14 anticipated 60 Complete https://irct.ir/trial/6148 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: At study baseline and after balanced blocked randomization, subjects will be randomly divided into two groups to take either inofolic supplementation or metformin. Randomization will be done by the use of computer-generated random numbers. 3 Polycystic ovarian syndrome. Intervention 1: Intervention group: Inofolic supplements (Loli, Rome, Italy), 2000 mg myo-inositol, 200 µg folic acid, twice a day, for 12 weeks orally. Intervention 2: Control group: Metformin tablet (Tehran Darou,Tehran, Iran), according to the patient's tolerance, daily for 12 weeks orally. 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 Undecided - It is not yet known if there will be a plan to make this available
public Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences scientific Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Patients with PCOS according to Rotterdam criteria 18 years 40 years Female Smokers The intake of folate supplements within the last 3 months Pregnant women Individuals with metabolic diseases Thyroid disease Hyperprolactinemia and hypercortisolemia E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Intervention group: Inofolic supplements (Loli, Rome, Italy), 2000 mg myo-inositol, 200 µg folic acid, twice a day, for 12 weeks orally. Control group: Metformin tablet (Tehran Darou,Tehran, Iran), according to the patient's tolerance, daily for 12 weeks orally. Beck scor. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire. GHQ score. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire. DASS-28 score. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire. Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Total glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Vice chancellor for research, Arak University of Medical Sciences Approved 2016-06-13 Ethics committee of Arak University of Medical Sciences Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak Arak Markazi Iran (Islamic Republic of)