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IRCT20120415009472N21 IRCT 2020-01-06 Iran University of Medical Sciences Effect of Sumac in treatment of polycystic ovary syndrome Effect of Sumac powder on Antioxidant indices and Uric Acid in women with polycystic ovary syndrome 2018-04-04 anticipated 88 Complete https://irct.ir/trial/41613 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: For randomization, the method of block randomization will be used with quadrilateral blocks. According the sample size of 88, the 22 quadruple blocks will be produced. For the purpose of concealment in the randomization process, individual codes will be used on supplements boxes that code is also generated by the software. By intering each persons to study, Based on the generated sequence, Supplementary box that code has been registered on that, will allocate to the person, Blinding description: For the purpose of concealment in the randomization process, individual codes will be used on supplements boxes that code is also generated by the software. This study is a two-blind study in which participants, principal investigator and health care personnel are keeping blind. N/A Polycystic ovary syndrome. Intervention 1: Control group: Patients referring to Akbar Abadi Hospital who are willing to cooperate and have inclusion criteria will recieve starch. They will use 3 gram Starch from Golha factory ( 3 capsules of 1 gram) for 3 months. Intervention 2: Intervention group: Patients referring to Akbar Abadi Hospital who are willing to cooperate, have inclusion criteria. and receive sumac powder. They will consume 3 gram sumac making by the Golha factory ( 3 capsules of 1 gram) for 3 months. Yes - There is a plan to make this available What will be shared: Information about the questionnaires includes demographic information, 24-hour recall, physical activity, as well as clinical and biochemical outcomes after unidentifiable individuals will be publish. When: The start of access period is from 1399 solar year equivalent to 2020 A.D To whom: All individuals, including researchers who working in university and scientific places, physicians, nutritionists and those engaged in the industry, can use these documentations. Conditions: Use of the documentation is permitted if there is no copyng and no citation or inappropriate citation. Where to obtain: Dr Nahid Aryaeian How to obtain: If the journal is free, the documents is availabe at the scientific search bases. Otherwise will need to pay money. Comments:
public Dr Naheed Aryaeian
Nutrition group, School of health, Iran University Of Medical Science, Hemmat Highway
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8670 4750 n-aryaeian@sina.tums.ac.ir Iran University of Medical Sciences scientific Dr Naheed Aryaeian
Nutrition group, School of health, Iran University Of Medical Science, Hemmat Highway
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8670 4750 n-aryaeian@sina.tums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patients with Polycystic ovary Syndrome based on two criteria of the three diagnostic criteria of the disease based on Rotterdam: 1.Bleeding is reduced or discontinued (as Delay more than 35 days or less than 8 bleeding episodes per year) 2. Clinical symptoms including hirsutism or Ferriman-Gallway (MGF) score above 8, acne and male pattern baldness and biochemical symptoms of increased androgenesis. 3. Polycystic ovary (12 or more of 12 follicles per ovary with a diameter of 2 to 9 mm, or an increase in ovarian volume to more than 310 ml). Patients with age between 20 to 40 years old. patient's acceptance of taking part in the study. 20 years 40 years Female Those who take drugs of anticoagulants and hyperlipidemia Use Tobacco Having kidney disease, diabetes, liver disease, cardiovascular disorders, hypothyroidism, inflammatory and rheumatic diseases, hyperprolactinemia, Cushing's syndrome, and congenital adrenal hyperplasia Follow a particular diet in the last three months. Take medications that affect insulin sensitivity, inflammation, or lipid profile and hormonal profile, including glucocorticoid drugs, ovulation induction drugs, anti-obesity, anti-diabetes, antihypertensive, estrogenic, anti-androgen, over the past 3 months Unwilling to participate in the study Use of Nutrition Supplements in the last 2 months Pregnancy or breastfeeding Sensitization or allergy to sumac Poly cysti E28.2 Placebo Placebo Control group: Patients referring to Akbar Abadi Hospital who are willing to cooperate and have inclusion criteria will recieve starch. They will use 3 gram Starch from Golha factory ( 3 capsules of 1 gram) for 3 months. Intervention group: Patients referring to Akbar Abadi Hospital who are willing to cooperate, have inclusion criteria. and receive sumac powder. They will consume 3 gram sumac making by the Golha factory ( 3 capsules of 1 gram) for 3 months. Serum malondialdehyde. Timepoint: Before intervention and 3 months after intervention. Method of measurement: colorimetric method. Glutathione peroxidase. Timepoint: Before intervention and 3 months after intervention. Method of measurement: colorimetric method. Superoxide dismutase. Timepoint: Before intervention and 3 months after intervention. Method of measurement: colorimetric method. Total antioxidant capacity. Timepoint: Before intervention and 3 months after intervention. Method of measurement: elisa method. Uric acid. Timepoint: Before intervention and 3 months after intervention. Method of measurement: turbiditymetery method. Dietry intake. Timepoint: Before intervention and 3 months after intervention. Method of measurement: 24-hour questionnaire food intake for 3 days and analysis with N4 software. Anthropometric indices. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Meters, scales and computing. Physical activity. Timepoint: Before intervention and 3 months after intervention. Method of measurement: International Physical Activity Questionnaire. Research deputy of Iran University of Medical Science Approved 2019-12-10 Ethics commitee of Iran University of Medical Science Iran University of Medical Science, Next to Milad tower, Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)