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IRCT20180404039187N3 IRCT 2019-04-09 Tabriz University of Medical Sciences Study the effects of probiotic supplementation on polycystic ovary syndrome Study the effects of probiotic supplementation on metabolic parameters and level of androgens in women with polycystic ovary syndrome: a randomized double-blind, clinical trial 2018-08-23 anticipated 84 Complete https://irct.ir/trial/36270 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Arrangement of the randomization process: 1) Determining the volume of each block (quadruple blocks) 2) Preparing the list of the blocks and assigning a number to each of them AABB(1) ABAB(2) ABBA(3) BBAA(4) BABA(5) BAAB(6) 3) Choosing random numbers between 1 and 6 4) Defining the treatment assignment list For example: AABB(1)_BBAA(4)_ABAB(2)_BABA(5), Blinding description: The participants (patients) and the researcher who has the task of sampling in the study, and the analyser are all blind during the study. At the patient's level, blindness will be done using a placebo, in which it will be given the probiotic to a group and placebo to another group, and patients will not be informed that they received a probiotic capsule or a placebo capsule that looks completely identical. The researcher will give patients a medicine or placebo only on the basis of lableA or B without knowing the nature of A, B, and according to the randomized list. 3 Polycystic ovary syndome. Intervention 1: Intervention group:daily administration of 1 probiotic capsule "DAILYEAST" for 3 months(a product of zist takhmir company). Intervention 2: Control group:daily administration of 1 plasebo capsule "DAILYEAST" for 3 months(a product of zist takhmir company). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I have no definitive decision
public Elnaz Shaseb
Faculty of pharmacy, Tabriz University of Medical Scince, Golgasht Ave,. Azadi Ave.
Tabriz Iran (Islamic Republic of) 5166614766 +98 144933344198 elnaz_shaseb_64@yahoo.com Tabriz University of Medical Sciences scientific Elnaz Shaseb
Faculty of Pharmacy, Tabriz university of Medical Science, Golgaste Ave., Azadi Ave.
Tabriz Iran (Islamic Republic of) 5166614766 +98 144933344198 Elnaz_shaseb_64@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) patients whom have polycystic ovary syndrome based on the ultrasond tests 18 years 45 years Female hypertension Hyperprolactinemia Renal failure Liver failure Heart failure Cancer Diabetes Hyperthyroidism Hypothyroidism Smoking E28.2 Polycystic ovarian syndrome Treatment - Drugs Placebo Intervention group:daily administration of 1 probiotic capsule "DAILYEAST" for 3 months(a product of zist takhmir company) Control group:daily administration of 1 plasebo capsule "DAILYEAST" for 3 months(a product of zist takhmir company) Fasting blood sugar level. Timepoint: At the beginning and 3 months later. Method of measurement: laboratory tests(enzymatic). Testestrone. Timepoint: At the beginning and 3 months later. Method of measurement: laboratory tests(immuno assay). Dehydroepiandrosterone sulfate. Timepoint: At the beginning and 3 months later. Method of measurement: laboratory tests(immuno assay). Tabriz University of Medical Sciences Approved 2018-10-08 Ethics Committee of Tabriz University of Medical Sciences Research & Technology Dept, Central Building No. 2, Third Floor, Tabriz University of Medical Sciences, Golghast St, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)