]>
IRCT20090117001556N144 IRCT 2022-06-26 Tehran University of Medical Sciences The effect of sulforaphane on depression in women with PCOS Evaluating the effect of sulforaphane supplementation in women with Polycystic ovary syndrome (PCOS) on depression, insulin resistance, and lipid profile change 2022-08-23 anticipated 50 Complete https://irct.ir/trial/64411 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization: using A and B blocks with n=4; AABB, ABAB, ABBA, BABA, BAAB, BBAA. We randomly use the blocks to achieve total sample size. ("A" and "B" are the study groups). The best way to create randomization is to use random allocation. Random allocation in clinical trial studies refers to the process of randomly dividing participants into different groups. Randomization gives each participant an equal chance to participate in each group. Successful randomization requires that researchers and study participants be unable to predict the type of intervention received, Blinding description: The participants, care providers and outcome assessors will be blind regarding grouping. All the participants believe that they are taking the main medication (the participants who are taking placebo are not aware of it). Care providers and outcome assessors do not know which participants have received the main medication and which participants have received placebo. Thus, there is no orientation in their work process. 2-3 Severity of depression. Intervention 1: Intervention group: Women with PCOS take sulforaphane 15 mg twice a day for 12 weeks. Intervention 2: Control group: Women with PCOS take placebo twice a day for 12 weeks. Yes - There is a plan to make this available What will be shared: The data will be distributed through final report When: 5 years from 2023 to 2028 To whom: Academic researchers Conditions: Users should cite the resource of data Where to obtain: Prof Shahin Akhondzadeh How to obtain: By E-mail Comments:
public Dr. Shahin Akhondzadeh
Roozbeh Hospital, South Kargar Street, Tehran
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 2222 s.akhond@sina.tums.ac.ir Tehran University of Medical Sciences scientific Dr. Shahin Akhondzadeh
Roozbeh Hospital, South Kargar Street, Tehran
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 2222 s.akhond@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of PCOS according to Rotterdam Mild to moderate depression 18-40 years old BMI = or > 25 High blood fat Disruption of Glucose tolerance test 18 years 40 years Female Smoking Lactation or gestation Metabolic or thyroid dysfunction Hyperprolactinemia Hypercortisolemia Severe depression CNS drugs used such as antidepressants or anxiolytics Insulin administration Uncontrolled blood glucose level Intense physical activity History of severe stress Emotional failure or hospitalization in recent past History of mental health problems in first-degree relatives E28.2 Polycystic ovarian syndrome Treatment - Drugs Placebo Intervention group: Women with PCOS take sulforaphane 15 mg twice a day for 12 weeks. Control group: Women with PCOS take placebo twice a day for 12 weeks. Severity of depression. Timepoint: Baseline and weeks 4, 8, & 12. Method of measurement: By Hamilton Depression Rating Scale (HDRS). Tehran University of Medical Sciences Approved 2022-03-28 School of Medicine Ethics Committee, Tehran University of Medical Sciences School of Medicine, Tehran University of Medical Sciences, Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)