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IRCT201410142709N31 IRCT 2014-12-11 Vice Chancellor for research, Iran University of Medical Sciences, Effect of rhubarb in diabetes type 2 Comparison of the rhubarb plant extract compared to placebo on oxidative stress, fasting blood glucose, apolipoprotein B, apolipoprotein A1 and insulin levels in patients with type 2 diabetes 2015-04-04 anticipated 60 Complete https://irct.ir/trial/2543 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Three types of capsules are used in this study: (1) aqueous extract of rhubarb, (2) alcoholic extract of rhubarb, and (3) placebo.The aqueous extract of rhubarb, alcoholic extract of rhubarb, and placebo are as similar capsules with same color and appearance and packaged in similar containers and therefore the patients are not aware of the type of capsules which they take .Also, the researchers are not aware of type of capsules and name of groups. Therefore, this will be a double-blind study. N/A Diabetes type 2. Intervention 1: Intervention group 1: Every day, members of the intervention group 1 receive three 450 mg oral capsules of the aqueous extract of rhubarb for six weeks which is made at School of Pharmacy, Shahid Beheshti University of Medical Sciences. Intervention 2: control group: Every day, members of the control group receive three 450 mg oral capsules of the placebo for six weeks which is made at School of Pharmacy, Shahid Beheshti University of Medical Sciences. Intervention 3: Intervention group 2: Every day, members of the intervention group 1 receive three 450 mg oral capsules of the alcoholic extract of rhubarb for six weeks which is made at School of Pharmacy, Shahid Beheshti University of Medical Sciences.
public Farzad Shidfar
School of Health, Iran University of Medical Sciences,Shahid Hemmat Expressway, between Chamran and Sheikh Fazlollah Expressway.
Tehran Iran (Islamic Republic of) +98 21 8862 2755 farzadshidfar@yahoo.com Iran University of Medical Sciences scientific Farzad Shidfar
School of Health,Iran University of Medical Sciences,Shahid Hemmat Expressway,Between Chamran and Sheykh Fazolah Expressway
Tehran Iran (Islamic Republic of) +98 21 8862 2755 farzadshidfar@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 30-60-year old patients with fasting blood glucose of greater than 126 mg/dl are included in the project. Exclusion criteria: Patients with hyperglycemia caused by diseases other than diabetes, patients suffering from liver, thyroid and kidney diseases, patients being treated with insulin, taking β-blockers and lipid-lowering drugs, consuming alcoholic drinks, having severe, acute, active infectious diseases when blood samples are taken, and patients who are hospitalized during the study are excluded from the study 30 years 60 years Both E10, E11, Insulin-dependent diabetes mellitus, Non-insulin-dependent diabetes mellitus, Malnutrition-related diabetes mellitus, Other specified diabetes mellitus, Unspecified diabetes mellitus Treatment - Drugs Placebo Treatment - Drugs Intervention group 1: Every day, members of the intervention group 1 receive three 450 mg oral capsules of the aqueous extract of rhubarb for six weeks which is made at School of Pharmacy, Shahid Beheshti University of Medical Sciences. control group: Every day, members of the control group receive three 450 mg oral capsules of the placebo for six weeks which is made at School of Pharmacy, Shahid Beheshti University of Medical Sciences. Intervention group 2: Every day, members of the intervention group 1 receive three 450 mg oral capsules of the alcoholic extract of rhubarb for six weeks which is made at School of Pharmacy, Shahid Beheshti University of Medical Sciences. Body Mass Index. Timepoint: Before and 6 weeks after intervention. Method of measurement: SECA,Kilogram per meter Square. Malondialdehyde. Timepoint: Before intervention and 6 weeks after intervention. Method of measurement: Spectrophotometry, mmol/L. High sensitivity c-reactive protein. Timepoint: Before and 6 weeks after intervention. Method of measurement: immunoturbidimetry, mg/dl. Fasting Blood Sugar. Timepoint: Before and 6 weeks after intervention. Method of measurement: glucose oxsidase , mg/dl. Apolipoprotein B. Timepoint: Before and 6 weeks after intervention. Method of measurement: immunoturbidimetry, mg/dl. Apolipoprotein A1. Timepoint: Before and 6 weeks after intervention. Method of measurement: immunoturbidimetry, mg/dl. Insulin level. Timepoint: Before and 6 weeks after intervention. Method of measurement: enzymatic, mg/dl. Blood Pressure. Timepoint: Before and 6 weeks after intervention. Method of measurement: Mercury Sphygmomanometer, mmHg. Vice Chancellor for research, Iran University of Medical Sciences, Approved 2014-10-12 Ethics committee of Iran University of Medical Sciences The Central Office, Iran University of Medical sciences, Shahid Hemmat Expressway, between Chamran and Sheikh Fazlollah Expressway Tehran Iran (Islamic Republic of)