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IRCT201605225623N80 IRCT 2016-06-04 Vice chancellor for research, Arak University of Medical Sciences Effect of supplementation in treatment of women with polycystic ovary syndrome Clinical trial of the effect of Q10 supplementation compared with the placebo on levels of gene expression related with glycemic control and inflammatory factors in women with polycystic ovary syndrome 2016-04-25 anticipated 60 Complete https://irct.ir/trial/6110 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 60 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients will be randomly assigned into each intervention group by their numbers, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Clinic who is not involved in the trial and not aware of random sequences will be allocated the numbered bottles of capsules to participants. Supplements and placebo are in the same packaging at the pharmaceutical company. Only the code is written on the packages. Patients and researcher do not know the type of drug and after analyzing the data, packet codes are decoded. 3 Polycystic ovary syndrome. Intervention 1: Intervention group: 100 mg Q10 (Nature, New York, USA), once a day, for 12 weeks orally. Intervention 2: Control group: Placebo (Barij Essence, Kashan, Iran), once a day, for 12 weeks orally. 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 Undecided - It is not yet known if there will be a plan to make this available
public Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 81151-87159 +98 31 5554 2999 asemi_r@yahoo.com Kashan University of Medical Sciences scientific Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 1771844351 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with PCOS according to Rotterdam criteria Aged 18 to 40 years 18 years 40 years Female Pregnant women Adrenal hyperplasia Androgen-secreting tumors Hyperprolactinaemia Thyroid dysfunction Diabetes or impaired glucose tolerance Gastrointestinal problems No hormonal treatments in the previous 6 months in the study E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Intervention group: 100 mg Q10 (Nature, New York, USA), once a day, for 12 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), once a day, for 12 weeks orally. Expressed levels of PPAR-γ. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR. Expressed levels of GLUT1 gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR. Serum insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Eliza. Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation with HOMA formula. Expressed levels of TNFα gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR. Expressed levels of TGFB gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR. Expressed levels of IL-1 gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR. Expressed levels of IL-8 gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR. Expressed levels of LDLR gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR. Expressed levels of Lp(a) gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR. Fasting plasma glucose. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. VLDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. LDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. HDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Vice chancellor of research, Bushehr University of Medical Sciences Vice chancellor of research, Kashan University of Medical Sciences Vice chancellor for research, Arak University of Medical Sciences Vice chancellor of research, Bushehr University of Medical Sciences Vice chancellor of research, Kashan University of Medical Sciences Approved 2016-04-24 Ethics committee of Arak University of Medical Sciences Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak Arak Markazi Iran (Islamic Republic of)