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IRCT2016083017756N4 IRCT 2016-09-15 Vice-Chancellery for Research and Technology, Birjand University of Medical Sciences An inquiry into saffron's effects on dyslipidemia A study of the effects of saffron petals' aqueous extract on lipid profile in patients with dyslipidemia 2016-09-22 anticipated 50 Complete https://irct.ir/trial/16247 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2-3 Dyslipidemia. Intervention 1: Intervention Group: A total of 25 patients with dyslipidemia will be selected by convenience sampling method based on inclusion criteria and assigned into this group using random digits table. Saffron petal tablets will be made by the Faculty of Pharmacy, Kerman University of Medical Sciences, at a dose of 30 mg/kg body weight. Tablets will be given blindly to the patients so that they will take a pill daily after a main meal for 28 days. Before and 28 days after the intervention, patient blood samples will be taken to measure the related variables. Intervention 2: Control Group: A total of 25 patients with dyslipidemia will be selected by convenience sampling method based on inclusion criteria and assigned into this group using random digits table. Placebo tablets will be made by the Faculty of Pharmacy, Kerman University of Medical Sciences, at a dose of 30 mg/kg body weight. Tablets will be given blindly to the patients so that they will take a pill daily after a main meal for 28 days. Before and 28 days after the intervention, patient blood samples will be taken to measure the related variables.
public Dr Reyhane Hoshyar
Ghaffari St.,
Birjand, Iran (Islamic Republic of) 9717853577 +98 938 258 8299 reyhaneh.houshyar@gmail.com Birjand University of Medical Sciences scientific Dr Reyhane Hoshyar
Ghaffari St.,
Birjand, Iran (Islamic Republic of) 9717853577 +98 938 258 8299 reyhaneh.houshyar@gmail.com Birjand University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: patients with lipid disorders (HDL≤40; LDL≥130; TG≥200; total cholesterol≥200 mg/dl); Not receiving antidyslipidemic drugs; age from 30 to 60 years; no history of stroke or heart surgery; lack of genetic dyslipidemic disease; provision of informed consent. Exclusion criteria: use of antidyslipidemic drugs during the study; incidence of myocardial infarction or heart surgery during the study; occurrence of unexpected circumstances for the participant such as an accident, death, etc.; failure to use saffron or placebo pills during the study, even for a single day 30 years 60 years Both e78.1 Pure hyperglyceridaemia Treatment - Drugs Treatment - Drugs Intervention Group: A total of 25 patients with dyslipidemia will be selected by convenience sampling method based on inclusion criteria and assigned into this group using random digits table. Saffron petal tablets will be made by the Faculty of Pharmacy, Kerman University of Medical Sciences, at a dose of 30 mg/kg body weight. Tablets will be given blindly to the patients so that they will take a pill daily after a main meal for 28 days. Before and 28 days after the intervention, patient blood samples will be taken to measure the related variables. Control Group: A total of 25 patients with dyslipidemia will be selected by convenience sampling method based on inclusion criteria and assigned into this group using random digits table. Placebo tablets will be made by the Faculty of Pharmacy, Kerman University of Medical Sciences, at a dose of 30 mg/kg body weight. Tablets will be given blindly to the patients so that they will take a pill daily after a main meal for 28 days. Before and 28 days after the intervention, patient blood samples will be taken to measure the related variables. Triglyceride. Timepoint: Before and 28 days after intervention. Method of measurement: Pars Azmoon kit and Autoanalyzer. Total cholesterol. Timepoint: Before and 28 days after intervention. Method of measurement: Pars Azmoon kit and Autoanalyzer. LDL. Timepoint: Before and 28 days after intervention. Method of measurement: Pars Azmoon kit and Autoanalyzer. HDL. Timepoint: Before and 28 days after intervention. Method of measurement: Pars Azmoon kit and Autoanalyzer. Liver enzymes. Timepoint: Before and 28 days after intervention. Method of measurement: Pars Azmoon kit and Autoanalyzer. Vice-Chancellery for Research and Technology, Birjand University of Medical Sciences Approved 2015-11-22 Ethics Committee of Birjand University of Medical Sciences Ghaffari St. Birjand Iran (Islamic Republic of)