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IRCT20161203031212N2 IRCT 2020-02-26 Esfahan University of Medical Sciences The effect of garlic on polycystic ovary syndrome The effect of Garlic (Allium sativum) consumption on indices of oxidative stress, insulin resistance, lipid profile and testosterone hormone in women with polycystic ovary syndrome(PCOS) 2020-02-20 anticipated 68 Complete https://irct.ir/trial/42975 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: Simple randomization is used. The randomization unit is individual. The randomization tool is a random number table, Blinding description: This study is a double-blind clinical trial. In this study, all participants, executor of plan, researcher, health care personnel such as physician and all laboratory personnel are kept blind to assigned study groups. 3 Polycystic Ovarian Syndrome(PCOS). Intervention 1: Intervention group: The intervention group consumed 800 mg of garlic tablets daily for 2 months. Intervention 2: The control group consumed 800 mg of placebo daily for 2 months. Yes - There is a plan to make this available What will be shared: If the individual data of the sample is unrecognizable, sharing the whole data is fine. When: 3 months after the results To whom: This data is only available to academic researchers. Conditions: The data is for personal use only and is not licensed for analysis. Where to obtain: Amir Mansour Alavi Naini Email address: am.alavi@nutr.mui.ac.ir How to obtain: The applicant can send his application to the responsible author's email address and after reviewing the application, documentation is provided to the applicant. Comments:
public Amir Mansour Alavi Naini
School Of Nutrition & Food Sciences, Isfahan University of Medical Sciences,Hezarjerib Street, Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3154 am.alavi@nutr.mui.ac.ir Esfahan University of Medical Sciences scientific Amir Mansour Alavi Naini
School Of Nutrition & Food Sciences, Isfahan University of Medical Sciences,Hezarjerib Street, Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3154 am.alavi@nutr.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) All women with polycystic ovary syndrome who are at least 18 and up to 45 years old 18 years 45 years Female People who follow a certain diet People who follow a specific exercise program People undergoing any drug treatment such as spironolactone, finasteride, isotretinoin, letrozole, clomiphene, gonadotropins, rosiglitazone, pioglitazone, or surgery such as laparoscopic ovarian surgery and assisted reproductive technology (PCOS) to treat symptoms they do Any serious or significant systemic illness requiring treatment such as cancer, gastrointestinal, hepatic or endocrine disorders, thyroid dysfunction, diabetes mellitus, hyperprolactinemia, cardiovascular disorders, renal disorders, blood coagulation disorders, neurological disorders, Insomnia, Pemphigus Disease, Joint Rheumatism and Non-Related Reproductive Disorders (PCOS) History of pregnancy hypertension Family history of stroke Any of the following: Alcohol, tobacco, anti-estrogens, oral or injectable corticosteroids Pregnancy lactation Menopause Use of anticoagulants such as warfarin and heparin, Taking aspirin History of any allergy, intolerance or harmful drug reaction to garlic and its products Taking garlic pills or supplements containing garlic at least 2 months before the intervention E28.2 Polycystic Ovarian Syndrome(PCOS) Treatment - Other Placebo Intervention group: The intervention group consumed 800 mg of garlic tablets daily for 2 months. The control group consumed 800 mg of placebo daily for 2 months. Total Antioxidant Capacity (TAC). Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: Colorimetric method. Malon Di Aldehyde (MDA). Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: Colorimetric method. Lipid profile. Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: Spectrophotometry. Fasting blood sugar(FBS). Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: Spectrophotometry. Insulin. Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: It will be measured by ELISA kit. Insulin Resistance (HOMA-IR). Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: Will be measured computationally. Testosterone hormone. Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: It will be measured by ELISA kit. Glutathione(GSH). Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: Colorimetric method. Catalase(CAT). Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: Colorimetric method. Sex Hormone Binding Globulin (SHBG). Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: It will be measured by ELISA kit. Blood pressure. Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: sphygmomanometer. Weight. Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: Balance. Body Mass Index(BMI). Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: Balance and meter. Waist. Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: meter. Around the abdomen. Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: meter. Hip circumference. Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: meter. Esfahan University of Medical Sciences Approved 2019-06-26 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezarjarib Street, Isfahan Isfahan Isfehan Iran (Islamic Republic of) Approved 2021-03-10 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezarjarib Street, Isfahan Isfahan Isfehan Iran (Islamic Republic of)