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IRCT20110731007165N11 IRCT 2020-12-25 Tehran University of Medical Sciences Valuating the effect of inofolic supplementation on depression in Poly cystic ovarian syndrome women Evaluating the effect of inofolic supplementation on depression in Polycystic ovarian syndrome women with mild to moderate depression 2021-01-09 anticipated 106 Complete https://irct.ir/trial/52952 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization list (block randomization list)will be prepared by the statistician. Treatments will be placed in sealed envelopes and will be kept by the out-of-study nurse. After identification of the eligibility of the patient, the procedure will be explained to her and informed consent will be obtained. The intervention will be performed by the kind of intervention in the envelope, Blinding description: Completion of the final information is up to the person who is unaware of the type of treatment and also the specialist will be blind. But the patient knows the type of intervention. 3 Depression. Intervention 1: Intervention group: Inofolic Powder twice daily for 12 weeks. Intervention 2: Control group: Without intervention. 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 It is not yet known if there will be a plan to make this available
public Dr. Ladan Kashani
Arash Hospital, Rashid Street, Tehran Pars
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7788 3195 Kashani_ladan@tums.ac.ir Tehran University of Medical Sciences scientific Dr. Ladan Kashani
Arash Hospital, Rashid Street, Tehran Pars
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7788 3195 Kashani_ladan@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 18-40 years With mild to moderate depression BMI <= 30 18 years 40 years Female Smoking Taking folate supplements in the last 3 months Metabolic and thyroid disorders Hyperprolactinemia Hypercortisolemia Severe depression Use of drugs affecting the nervous system (such as antidepressants and anti-anxiety drugs) Insulin use Lack of blood sugar control Intense physical activity Pregnancy Lactation History of mental health problems in first degree relatives, Other diseases in addition to depression F32.8 Other depressive episodes Treatment - Drugs N/A Intervention group: Inofolic Powder twice daily for 12 weeks Control group: Without intervention Changes in the level of depression. Timepoint: Before and after intervention. Method of measurement: Hamilton Depression Rating Scale (HDRS). The blood tests for LDH,HDL,Total cholesterol ,TG, BMI, waist hip ratio , fasting glucose and insulin. Timepoint: Before and after the intervention. Method of measurement: The blood test. Tehran University of Medical Sciences Approved 2020-12-12 Ethics Committee of Tehran University of Medical Sciences Qods St, Keshavarz Blvd, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)