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IRCT20170207032439N2 IRCT 2017-12-14 Shiraz University of Medical Sciences Evaluating the effect of consumption of synbiotic pomegranate juice in women with Poly Cystic Ovarian Syndrome synbiotic pomegranate juice Evaluating the effect of consumption of synbiotic pomegranate juice on lipid profile, anthropometric markesrs and quality of life in women with Poly Cystic Ovarian Syndrome 2017-02-19 anticipated 92 Complete https://irct.ir/trial/25273 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: We randomly assigned patients to a ratio of 1: 1: 1: 1 to 4 groups. A scholar who did not have any clinical intervention, randomly classified the patinets by random blocking software with a fixed block size of 4 in randomized groups. In order to blind patients, the drinks in all groups are identical in appearance, color and taste. The drinks are coded differently in each group and then will be given to the scholar to blinde him. Finally, the data and information are also given to the analyzer with the special code for each group in order to blinde analayzer, Randomization description: Balanced Block Randomization, Blinding description: Beverages in all groups are identical in terms of appearance, color and taste.Drinks with different codes in each group will be given to blindness to the researcher and Finally, the data and information are also given to the statistics specialist by the special code for each group to make a blindfold for the statistics specialist. N/A Poly cystic ovarian syndrome. Intervention 1: Patients who receive 2 liters of synbiotic pomegranate juice each week, which consists of pomegranate juice, enriched with inulin and lactobacillus, in the form of disposable bottles for 8 weeks. Intervention 2: Patients who receive 2 liters of pomegranate juice each week, in the form of disposable bottles for 8 weeks. Intervention 3: Patients who receive 2 liters of synbiotic juice each week, which consists of placebo, enriched with inulin and lactobacillus, in the form of disposable bottles for 8 weeks. Intervention 4: Patients who receive 2 liters of placebo juice each week, which consists of pomegranate flavore, in the form of disposable bottles for 8 weeks. Yes - There is a plan to make this available What will be shared: Information about the consequences is shared When: Since 2019 To whom: Academic researchers Conditions: To evaluate the statistical analysis Where to obtain: Reza Barati reza93barati@gmail.com How to obtain: Maximum one week after receiving the application Comments:
public Zahra Esmaeilinezhad
Razi street
Shiraz Iran (Islamic Republic of) 8876115956 +98 71 3225 6271 sahar.esn8@gmail.com Shiraz University of Medical Sciences scientific Zahra Esmaeilinezhad
Razi street
Shiraz Iran (Islamic Republic of) 8876115956 +98 71 3225 6271 sahar.esnj8@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria PCOS could be diagnosed, after the exclusion of related disorders, by two of the following three features: Oligomenorrhea (Less Than 6-9 Menses per Year) or amenorrhea (no vaginal bleeding for at least 6 months); Clinical findings: Increased blood androgen levels (hirsutism higher than 7 or acne), or increased blood testosterone levels (testosterone levels above 2 nmol / l); Polycystic ovaries in ultrasound (presence of 12 or more cysts with a diameter of 9.2 mm inside one or both ovaries or the size of the ovary 10 cm 3 or more); BMI>18; Having permission the doctor and informed consent to participate in the study 15 years 48 years Female Other medical conditions related to excess androgens such as increased blood prolactin; nonclassical congenital adrenal hyperplasia; Cushing's syndrome; androgen-producing tumors and acromegaly wemon with severe diseases of the stomach, intestines, heart; kidne; liver; lung; chronic; autoimmune; inflammatory and AIDS; Patients undergoing chemotherapy; smokers; Lactating women Patients treated with corticosteroids and antibiotics; The use of supplements of vitamins; minerals and antioxidants; Those taking hormone pills or supplements; Patients using insulin to treat diabetes; Patients with a special diet; Patients with specific exercise program E28.2 Polycystic ovarian syndrome Treatment - Other Treatment - Other Treatment - Other Placebo Patients who receive 2 liters of synbiotic pomegranate juice each week, which consists of pomegranate juice, enriched with inulin and lactobacillus, in the form of disposable bottles for 8 weeks. Patients who receive 2 liters of pomegranate juice each week, in the form of disposable bottles for 8 weeks. Patients who receive 2 liters of synbiotic juice each week, which consists of placebo, enriched with inulin and lactobacillus, in the form of disposable bottles for 8 weeks. Patients who receive 2 liters of placebo juice each week, which consists of pomegranate flavore, in the form of disposable bottles for 8 weeks. Total Cholestrol. Timepoint: Before and 2 month after intervention. Method of measurement: Autoanalyzer. Triglyceride. Timepoint: Before and 2 month after intervention. Method of measurement: Autoanalyzer. HDL-C. Timepoint: Before and 2 month after intervention. Method of measurement: Autoanalyzer. LDL-C. Timepoint: Before and 2 month after intervention. Method of measurement: Autoanalyzer. Health-related quality of life in polycystic ovary syndrome patients. Timepoint: Before and 2 month after intervention. Method of measurement: Questionaire. Mensturation cycle. Timepoint: Before and 2 month after intervention. Method of measurement: Questionare. Shiraz University of Medical Sciences Approved 2010-09-23 Ethics Committee of Shiraz University of Medical Sciences Razi street Shiraz Fars Iran (Islamic Republic of)