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IRCT20210224050490N1 IRCT 2021-05-08 Tabriz University of Medical Sciences Melatonin in PCOS Investigating the effect of melatonin supplementation on plasma level of Visfatin and insulin sensitivity on women with polycystic ovarian syndrome 2021-04-24 anticipated 42 Complete https://irct.ir/trial/54601 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomized allocation performing, permuted block randomization will be used by biohedral blocks. According to the sample size of 42 subjects, 21 blocks will be generated using the online site (www.sealedenvelope.com). Participants will be entered into the study based on the produced sequence. The drug packets will be allocated to the individual with code on them. Therefore, participants will be unaware of the receiving intervention type, as well as the random sequence which will be hidden and unpredictable, Blinding description: To blind the study, unique codes will be used on the medicine boxes. Melatonin and placebo tablets will be placed into the same appearance boxes by an independent third party. Participants will be entered into the study based on the produced sequence. The drug packets will be allocated to the individual with code on them. Therefore, the participant and the researcher will be unaware of the type of treatment and the random sequence generated during the study will be unpredictable. 3 Polycystic ovarian syndrome. Intervention 1: Intervention group: Intake of 6 mg of melatonin (two tablets of 3 mg supplement of Nature Made, USA) one hour before bedtime, for 8 weeks. Intervention 2: Control group: Daily intake of two melatonin placebo (made by Pharmacy Faculty, Tabriz University of Medical Sciences) 1 hour before bed, 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 At the end of the study and according to the circumstances, will be decided on this issue.
public Fakhrosadat Fayazi
Golgasht street, Tabriz university of medical sciences
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3381 1902 fayazif@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr Mohammad Alizadeh
Golgasht street, Tabriz university of medical sciences
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 7581 mdalizadeh@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Women with PCOS 18-40 years old BMI 20-40 Willingness to cooperate 18 years 40 years Female Pregnancy Lactation Sleep disturbance Shift work Metabolic disease Taking drugs that cause or affect the symptoms of polycystic ovary syndrome Taking drugs that affect insulin sensitivity Takeing antioxidant supplements Following a special diet Losing weight more than 5% of current weight in the last 6 months Cigarettes and alcohol E28.2 Polycystic ovarian syndrome Treatment - Other Treatment - Other Intervention group: Intake of 6 mg of melatonin (two tablets of 3 mg supplement of Nature Made, USA) one hour before bedtime, for 8 weeks. Control group: Daily intake of two melatonin placebo (made by Pharmacy Faculty, Tabriz University of Medical Sciences) 1 hour before bed, for 8 weeks. Visfatin. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA kit. Fasting blood sugar. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Spectrophotometry. Insulin. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA kit. Insulin sensitivity. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: The quantitative insulin-sensitivity check index formula (QUICKI). Tabriz University of Medical Sciences Approved 2021-04-17 Ethics committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Attar Neyshabouri Av., Golgasht St. Tabriz East Azarbaijan Iran (Islamic Republic of)