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IRCT20220921056011N1 IRCT 2022-10-20 Ahvaz University of Medical Sciences Effect of grape seed extract (GSE) supplementation on serum levels of androgens, gonadotropins and high sensitivity c-reactive protein in women with polycystic ovary syndrome (PCOS) Effect of grape seed extract (GSE) supplementation on serum levels of androgens, gonadotropins and high sensitivity c-reactive protein in women with polycystic ovary syndrome (PCOS) 2022-10-23 anticipated 50 Complete https://irct.ir/trial/66003 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocked Randomization, Blinding description: The type of treatment is selected by numbering in the envelope. participates and researcher are not informed. Elsewhere, the numbers are computerized to determine whether the number is grape seed extract supplement or placebo. N/A Polycystic Ovary Syndrome. Intervention 1: Intervention group: They take a daily supplement of 250 mg of grape seed extract (GSE) for 8 weeks. Intervention 2: Control group: They take a placebo supplement daily for 8 weeks. Yes - There is a plan to make this available What will be shared: Part of the data, such as the information related to the main outcome, can be shared. When: The access period starts 6 months after the results are published To whom: It will be available for researchers working in academic and scientific institutions Conditions: Using the data to complete the research process regarding the effects of grape seed extract supplementation on the serum levels of androgens, gonadotropes, and high-sensitivity C-reactive protein in women with polycystic ovary syndrome. Where to obtain: Contact the email of the Corresponding author of the article resulting from the data of the research project. How to obtain: Contact the email of the Corresponding author of the article resulting from the data of the research project. Comments:
public Marzie Zilaiee
Golstan
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3311 2713 marziezilae67@gmail.com Ahvaz University of Medical Sciences scientific Marzie Zilaiee
Golstan
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3311 2713 marziezilae67@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Age 25 to pre-menopause BMI<=30 Diagnosis of PCOS based on the Rotterdam criteria and the diagnosis of a gynecologist 25 years 55 years Female E28.2 Polycystic ovarian syndrome Treatment - Drugs Placebo Intervention group: They take a daily supplement of 250 mg of grape seed extract (GSE) for 8 weeks. Control group: They take a placebo supplement daily for 8 weeks. Body mass index. Timepoint: before the start of the intervention and 8 weeks after taking the supplement. Method of measurement: ترازو. Waist-Hip Ratio (WHR). Timepoint: before the start of the intervention and 8 weeks after taking the supplement. Method of measurement: Meter. Testosterone. Timepoint: before the start of the intervention and 8 weeks after taking the supplement. Method of measurement: ELISA kit. Prolactin. Timepoint: before the start of the intervention and 8 weeks after taking the supplement. Method of measurement: ELISA kit. Luteinizing Hormone (LH). Timepoint: before the start of the intervention and 8 weeks after taking the supplement. Method of measurement: ELISA kit. Follicle-Stimulating Hormone (FSH). Timepoint: before the start of the intervention and 8 weeks after taking the supplement. Method of measurement: ELISA kit. Fasting insulin. Timepoint: before the start of the intervention and 8 weeks after taking the supplement. Method of measurement: ELISA kit. Homeostatic Model Assessment for Insulin Resistance. Timepoint: before the start of the intervention and 8 weeks after taking the supplement. Method of measurement: Formula. Fasting blood sugar. Timepoint: before the start of the intervention and 8 weeks after taking the supplement. Method of measurement: ELISA kit. Ahvaz University of Medical Sciences Approved 2022-07-16 Ahvaz Jondishapur University of Medical Sciences Golstan Ahavz Khouzestan Iran (Islamic Republic of)