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IRCT20091114002709N50 IRCT 2019-01-23 Iran University of Medical Sciences Curcumin in PCOS The effect of curcumin supplementation on glycemic control, antioxidant and anthropomethric indices, PGC1-α and SIRT1 gene expression in polycystic ovary syndrome(PCOS) women 2019-01-21 anticipated 72 Complete https://irct.ir/trial/35137 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: Our sample size is 72 subjects in two groups of 36 participants in each group. Block randomization method was designed using statistical software Stata Version 13. The number of blocks considered is 6, Blinding description: The random allocation list will be provided only to the statistical consultant. To hide the random allocation process, there are 72 paper labels with randomized 10-digit random codes and a specific frame that identifies the relevant treatment and will be the only methodologist of the design of the code. Labels will be arranged in random order on the drug packs. The drug packs will be arranged in a randomized random list. When the physician announces the eligibility of a patient, the methodologist will provide the package patient with the package. The person evaluating the outcomes is a third person who is unaware of the random allocation process and type of treatment. To analyze the data, a statistician who is separate from the study process and who is unaware of all the processes performed will be used. 3 Polycystic ovary syndrome. Intervention 1: Intervention group: Curcumin (Turmeric Extract) in 500 mg capsules (manufactured by Karen Company, Iran) three times a day for three months. Intervention 2: Control group: Placebo (Maltodextrin) with the same shape and design and color of the main intervention in 500 mg capsules. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Farzad Shidfar
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 2503 shidfar.f@iums.ac.ir Iran University of Medical Sciences scientific Farzad Shidfar
School of Health, Iran University of Medical Sciences, Shahid Hemmat highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8862 2755 shidfar.f@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) The willingness to voluntarily participate in the study Diagnosis of polycystic ovary syndrome by a specialist physician in the mild to moderate phase Having impaired glucose tolerance (IGT) The consumer is just one of the metformin or clomiphene drug groups Age more than 18 years old BMI higher than 25 and less than 30 kg/m2 18 years 50 years Female Change the type and dosage of the drug over the past month Congenital hormonal disorders, autoimmune diseases, cancer, inflammatory diseases, hyperthyroidism and hypothyroidism, infections, pregnancy or lactation in women, or use of contraceptive pills The use of multi-vitamin-mineral, omega-3, polyphenolic and antioxidant supplements, as well as the use of anticoagulants such as heparin and warfarin or aspirin, blood cholesterol-lowering drugs (statins), NSAIDs, such as ipobrofen, aspirin and diclofenac, Antihistamines, calcium channel antagonists such as nifedipine, anti-TNF drugs (infliximab, adalimumab and cinnura), glucocorticosteroids (cortisone, prednisolone) and spironolactone during in the past month. E28.2 Polycystic ovarian syndrome Treatment - Drugs Placebo Intervention group: Curcumin (Turmeric Extract) in 500 mg capsules (manufactured by Karen Company, Iran) three times a day for three months Control group: Placebo (Maltodextrin) with the same shape and design and color of the main intervention in 500 mg capsules Fasting Blood Sugar. Timepoint: At the beginning of the study (before the intervention) and the end of the study (3 months after the intervention). Method of measurement: laboratory kit. Fasting Insulin. Timepoint: At the beginning of the study (before the intervention) and the end of the study (3 months after the intervention). Method of measurement: laboratory kit. PGC1-α gene expression. Timepoint: At the beginning of the study (before the intervention) and the end of the study (3 months after the intervention). Method of measurement: Real Time RT-PCR. Sirt1 gene expression. Timepoint: At the beginning of the study (before the intervention) and the end of the study (3 months after the intervention). Method of measurement: Real Time RT-PCR. Serum GPx. Timepoint: At the beginning of the study (before the intervention) and the end of the study (3 months after the intervention). Method of measurement: laboratory kit. Serum SOD. Timepoint: At the beginning of the study (before the intervention) and the end of the study (3 months after the intervention). Method of measurement: laboratory kit. Serum Concentration of DHEA hormone. Timepoint: At the beginning of the study (before the intervention) and the end of the study (3 months after the intervention). Method of measurement: laboratory kit. Serum concentration of LH. Timepoint: At the beginning of the study (before the intervention) and the end of the study (3 months after the intervention). Method of measurement: laboratory kit. Serum Concentration of FSH hormone. Timepoint: At the beginning of the study (before the intervention) and the end of the study (3 months after the intervention). Method of measurement: laboratory kit. Insulin resistance. Timepoint: At the beginning of the study (before the intervention) and the end of the study (3 months after the intervention). Method of measurement: Computing. Iran University of Medical Sciences Approved 2018-10-28 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, IRAN Tehran Tehran Iran (Islamic Republic of)