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IRCT20220822055771N1 IRCT 2023-01-31 Shahre-kord University of Medical Sciences empagliflozin effect in polycystic ovarian syndrom ‏ Comparative study of the effect of metformin and empagliflozin on cardiometabolic, anthropometric and hormonal factors in women with polycystic ovarian syndrom 2022-11-22 anticipated 50 Complete https://irct.ir/trial/65537 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into two groups using balanced block randomization with a sample size of 4 samples in each block and random allocation of samples in both groups with the help of random allocation software. The result of random allocation is done by the consultant of methodology and study statistics and the type of allocation treatment is recorded on paper and each sample is placed in a separate package with a sample order code. When surgery is performed, clinicians who do not know the outcome of the allocation process in each sample until the time of surgery will open the packages. 3 Polycystic ovarian syndrome. Intervention 1: Intervention group: The people of this group are given empagliflozin 10 mg tablets (ABIDI company) once a day for three months. Intervention 2: Control group: The people of this group were given 1000 mg metformin tablets (Rahadaroo company) once a day for three months. 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 There is no further information
public Sara Khosravi
Hajar hospital, Parastar st.
Shahrekord Iran (Islamic Republic of) 8816754633 +98 38 3222 0016 St-khosravi.s@skums.ac.ir Shahre-kord University of Medical Sciences scientific Sara Khosravi
Hajar hospital, Parastar st.
Shahrekord Iran (Islamic Republic of) 8816754633 +98 38 3222 0016 St-khosravi.s@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) women between 15-55 years old polycystic ovarian syndrom 15 years 55 years Female Glomerular filtration rate<30 pregnant liver disease diabet mellitus urinary tract infection chronic disease on hypertention treatment E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Intervention group: The people of this group are given empagliflozin 10 mg tablets (ABIDI company) once a day for three months. Control group: The people of this group were given 1000 mg metformin tablets (Rahadaroo company) once a day for three months. Weight. Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: Digital scale. Body mass index. Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: Meter and scale. Waist circumfernce. Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: Measuring tape. Fasting blood sugar. Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: spectrophotometry. Hba1c. Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: HPLC. Total testestrone. Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: ECLIA. 17-oh progesterone. Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: ELISA. Dehydroepiandrosterone. Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: ELISA. AST (aspartate aminotransferase). Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: ELISA. Alanine transaminase(ALT). Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: ELISA. C-reactive protein (CRP). Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: ELISA. Triglycerides. Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: spectrophotometry. LDL (low-density lipoprotein). Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: spectrophotometry. HDL (high-density lipoprotein). Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: spectrophotometry. Total cholestrol. Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: spectrophotometry. Fasting insulin. Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: ELISA. Insulin resistance. Timepoint: before the start of the intervention and three months after the start of the intervention. Method of measurement: HOMA.IR. Shahre-kord University of Medical Sciences Approved 2022-06-22 Research Ethics Committees of School of Medicine - Shahrekord University of Medical Sciences School of Medicine, Rahmatieh Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)