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IRCT20170116031993N5 IRCT 2021-05-22 Ahvaz University of Medical Sciences The effects of rutin flavonoid on type 2 diabetes mellitus The effects of rutin flavonoid supplement consumption on blood pressure, heart rate, quality of life and some serum antioxidant enzymes in type 2 diabetic patients 2021-05-22 anticipated 48 Complete https://irct.ir/trial/55881 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Assignment of patients in each of the study groups (supplement or placebo) will be done by "Random allocation software" using classified randomized blocking method (block size: 4). In addition, in order to reduce selection bias error, allocation concealment will be used. This will be done by assigning unit codes (two codes A and B) to each patient's tablets. In this way, 48 patients will be randomly allocated to placebo (n = 24) or intervention (n = 24) groups. In fact, each patient will receive a can containing code A or B, and eventually 24 patients will receive cans containing code A and 24 patients will receive cans containing code B, Blinding description: In the present study, the doctor, researcher, and patients will be blinded to the study groups. Before starting the study, the cans containing the respective tablets will be coded by a person other than the researcher (this person will not aware of the details of the research) to A and B, so that the type of received tablets in each group will be blinded for researcher. Also, placebo and supplement tablets will be similar in terms of color, shape, size and taste. In addition, cans containing the supplement and placebo will be quite similar. 2-3 Type 2 diabetes mellitus. Intervention 1: Intervention group: Every day, one tablet of 1 g rutin (containing 500 mg of pure rutin and 500 mg other compounds include di-calcium phosphate, microcrystalline cellulose, plant cellulose, stearic acid, magnesium stearic, silica, glycerin), made by the Solgar company, USA, after meals for 90 days. Intervention 2: Control group: One tablet of 1 g placebo/day (containing compound similar to supplement except rutin), made by the Faculty of Pharmacy of Ahvaz Jundishapur University of Medical Sciences, in terms of shape, color, size similar to supplement, after meals for 90 days. No - There is not a plan to make this available Justification or reason for not sharing IPD is The person's information will be confidential and the results will be as collective statistics
public Hadi Bazyar
Department of Nutrition, School of Allied Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan St., Ahvaz
Ahvaz Iran (Islamic Republic of) 7853167465 +98 61 3333 0747 hadibazyar2015@gmail.com Ahvaz University of Medical Sciences scientific Ahmad Zare Javid
Department of Nutrition, School of Allied Medical Sciences, Jundishapur University of Medical Sciences, Golestan St., Ahvaz
Ahvaz Iran (Islamic Republic of) 6163764754 +98 74 3333 1257 ahmaddjavid@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study People between 20 to 60 years old in both sexes, Over at least 2 years from time of diagnosis of type 2 diabetes mellitus Body mass index (BMI) less than 35 (BMI ≤ 35) Glycosylated hemoglobin (HbA1c) between 6.5 to 11% 20 years 60 years Both Developing complications from diabetes such as renal failure Diabetic patients taking insulin Thyroid disease Anemia Pregnancy, lactation Smokers Use of other dietary supplements, probiotics and anti-inflammatory drugs Use of any antioxidant supplements in the last 3 months Use of immunosuppressive drugs Following of special diets other than the diet specific to diabetic patients, E11 Type 2 diabetes mellitus Treatment - Other Placebo Intervention group: Every day, one tablet of 1 g rutin (containing 500 mg of pure rutin and 500 mg other compounds include di-calcium phosphate, microcrystalline cellulose, plant cellulose, stearic acid, magnesium stearic, silica, glycerin), made by the Solgar company, USA, after meals for 90 days. Control group: One tablet of 1 g placebo/day (containing compound similar to supplement except rutin), made by the Faculty of Pharmacy of Ahvaz Jundishapur University of Medical Sciences, in terms of shape, color, size similar to supplement, after meals for 90 days. Systolic blood pressure, diastole, pulse pressure, mean arterial pressure and heart rate. Timepoint: Before and after the intervention. Method of measurement: Using digital sphygmomanometer. Quality of Life. Timepoint: Before and after the intervention. Method of measurement: Questionnaire 36 items. Catalase enzyme. Timepoint: Before and after the intervention. Method of measurement: ELISA kit. Superoxide dismutase enzyme. Timepoint: Before and after the intervention. Method of measurement: ELISA kit. Glutathione peroxidase. Timepoint: Before and after the intervention. Method of measurement: ELISA kit. Ahvaz University of Medical Sciences Approved 2021-05-15 The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan,Iran Ahvaz Khouzestan Iran (Islamic Republic of)