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IRCT20091114002709N46 IRCT 2018-02-11 Iran University of Medical Sciences Quercetin on thalassemia induced depression Study of the effect of oral quercetin supplement intake on mood in β-thalassemia major patients 2017-04-22 anticipated 84 Complete https://irct.ir/trial/28188 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The method of "permuted block randomization" will be used for the randomization, Blinding description: the researcher, participants, practitioner, and the statistical analyzer were all blinded in this study, which means non of them were aware of the supplement given to and consumed by patients were Quercetin or placebo. 2-3 beta thalassemia major. Intervention 1: Intervention group: a group of 42 thalassemia patients recieved quercetin tablets.They consumed one tablet containing 500 mg quercetin after lunch every day for 3 months and they were given information on possible side effects. Intervention 2: Control group: a group of 42 thalassemia patients recieved placebo tablets.They consumed one tablet containing 500 mg starch, cellulose, etc. after lunch every day for 3 months and they were given information on possible side effects. 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 No more information
public Dr Azita Azarkeivan
before Chamran intersection, East Hemmat Highway
Tehran Iran (Islamic Republic of) 2155888 +98 21 8800 9222 azazarkeivan@yahoo.com Blood Transfusion Education & Research Institute. scientific Dr Farzad Shidfar
before the Chamran Intersection, East Hemmat Highway
Tehran Iran (Islamic Republic of) 866974 +98 21 8670 4711 farzadshidfar@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) 18 to 40 year old male and female beta thalassemia major patients Inclination to cooperate and signing the written informed consent A minimum of 2 years of blood transfusion history blood specimen collection 20 days after the last blood transfusion Regular and peculiar iron-chelating therapy with desferrioxamine Vitamin C supplement intake with desferrioxamine 18 years 40 years Both Uncontrollable and life threatening complication due to due to the supplement intake;; ; ; ; ; ; A change in type or amount of the iron chelator Pregnancy or lactation Hepatitis infection and other metabolic or infectious diseases Less than 80% compliance of supplement intake Consumption of drugs that interfere with quercetin Drinking more than 500 mg/day of beverages rich in flavonoids Smoking or alcohol consumption D56.1 Cooley anaemia Severe beta thalassaemia Thalassaemia: intermedia major Treatment - Drugs Placebo Intervention group: a group of 42 thalassemia patients recieved quercetin tablets.They consumed one tablet containing 500 mg quercetin after lunch every day for 3 months and they were given information on possible side effects. Control group: a group of 42 thalassemia patients recieved placebo tablets.They consumed one tablet containing 500 mg starch, cellulose, etc. after lunch every day for 3 months and they were given information on possible side effects. Depression. Timepoint: before and after the intervention. Method of measurement: Beck's questionnaire. High-sensitivity C-reactive protein(hs-CRP). Timepoint: before and after the intervention. Method of measurement: using ELISA kit in Microgram/milliliter(micg/ml). Tumor necrosis factor α(TNF-α). Timepoint: before and after the intervention. Method of measurement: using ELISA kit in Picrogram/milliliter(pg/ml). Iran University of Medical Sciences Approved 2017-01-20 Ethics committee of Iran University of Medical Sciences After the Chamran Intersection, East Hemmat Highway Tehran Tehran Iran (Islamic Republic of)