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IRCT20140617018126N3 IRCT 2020-06-09 Tabriz University of Medical Sciences The effect of Urtica Dioica (Nettle), Vaccinium myrtillus on type 2 diabetes The effect of Urtica Dioica (Nettle), Vaccinium myrtillus on blood glucose parameters and lipid profile in patients with type 2 diabetes: a double-blind clinical trial 2021-02-19 anticipated 60 Complete https://irct.ir/trial/47971 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples will be randomly assigned to four blocks using Random Allocation Software. Blocking and allocation sequences for concealment will be done by the non-involved researcher (Allocation Concealment). The sample allocation ratio will be Allocation 1:1 and will be divided into two groups of receiving Urtica Dioica, Vaccinium myrtillus, and Placebo. Then based on blocks and allocation sequences each client will be given white pockets that are prepared in equal sizes and on which the numbers 1 to 60 are written (in order of allocation sequence). The pockets will contain white boxes containing Urtica Dioica, Vaccinium myrtillus, or Placebo capsules. Only the person in charge of packing Urtica Dioica, Vaccinium myrtillus, and Placebo capsules will know the numbers of the relevant pockets and none of the researchers or patients will know the type of medicine that each person receives. The first person will be given pocket number 1 and then it will continue until completion. Urtica Dioica, Vaccinium myrtillus, and placebo capsules will be similar in shape, size, color and, smell, Blinding description: Based on blocks and allocation sequences each client will be given white pockets that are prepared in equal sizes and on which the numbers 1 to 60 are written (in order of allocation sequence). The pockets will contain white boxes containing Urtica Dioica, Vaccinium myrtillus, or Placebo capsules. Only the person in charge of packing Urtica Dioica, Vaccinium myrtillus, and Placebo capsules will know the numbers of the relevant pockets and none of the researchers or patients will know the type of medicine that each person receives. The first person will be given pocket number 1 and then it will continue until completion. Urtica Dioica, Vaccinium myrtillus, and placebo capsules will be similar in shape, size, color, and smell. 3 Type 2 diabetes. Intervention 1: Intervention group: This group will receive the capsules (500 mg) of Urtica Dioica, Vaccinium myrtillus containing 300 mg Urtica Dioica extract and 150 mg of Vaccinium myrtillus extract every 12 hours and for 3 months. The capsules will be provided by Sina Noandish Tabiat Company. Intervention 2: Control group: This group will receive the placebo capsules (500 mg) containing additives every 12 hours and for 3 months. The capsules will be provided by Sina Noandish Tabiat Company. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Mostafa Araj-Khodaei
Aging Research Institute, Faculty of medicine, Tabriz University of Medical Sciences, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3334 2178 araj@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Mostafa Araj-Khodaei
Aging Research Institute, Faculty of medicine, Tabriz University of Medical Sciences, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3334 2178 araj@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Type 2 diabetes Taking hypoglycemic drugs (people who control their diabetes just by taking blood sugar-lowering drug) Age 40-70 years Body mass index 18.5–30 kg / m 2 Fasting blood sugar equal to or more than 126 mg / d 40 years 70 years Both Type 1 diabetes Other specific types of diabetes Insulin therapy over the past three months Having serious gastrointestinal diseases (GI) including gastric ulcers and gastrointestinal bleeding Have a history of diabetic ketoacidosis, non-ketotic hyperosmolar diabetic coma, severe infection or surgery in the previous month Uncontrolled high blood pressure (Blood pressure higher or equal to 160/100 mm Hg) mental illness Abuse or addiction to alcohol, psychoactive substances or other drugs Pregnancy, lactation or plan to become pregnant Having cardiovascular disease, renal insufficiency, liver dysfunction, thyroid dysfunction, parathyroid dysfunction, and cancers High physical activity Chronic complications of diabetes (neuropathy, retinopathy, according to patient records), diabetic nephropathy, hypothyroidism and hyperthyroidism Sensitivity to Nettle and Vaccinium myrtillus E08 Diabetes mellitus due to underlying condition Treatment - Drugs Placebo Intervention group: This group will receive the capsules (500 mg) of Urtica Dioica, Vaccinium myrtillus containing 300 mg Urtica Dioica extract and 150 mg of Vaccinium myrtillus extract every 12 hours and for 3 months. The capsules will be provided by Sina Noandish Tabiat Company. Control group: This group will receive the placebo capsules (500 mg) containing additives every 12 hours and for 3 months. The capsules will be provided by Sina Noandish Tabiat Company. Fasting Blood Sugar. Timepoint: Blood tests before starting the drug and three months later (after taking the drug completely). Method of measurement: Fasting Blood Sugar Test. HbA1C. Timepoint: Blood tests before starting the drug and three months later (after taking the drug completely). Method of measurement: HbA1C test. Creatinine. Timepoint: Blood tests before starting the drug and three months later (after taking the drug completely). Method of measurement: Creatinine Test. Fasting Insulin. Timepoint: Blood tests before starting the drug and three months later (after taking the drug completely). Method of measurement: Fasting Insulin Blood Test. Cholesterol. Timepoint: Blood tests before starting the drug and three months later (after taking the drug completely). Method of measurement: Cholesterol Test. Triglyceride. Timepoint: Blood tests before starting the drug and three months later (after taking the drug completely). Method of measurement: Triglyceride Test. Tabriz University of Medical Sciences Approved 2020-04-20 Ethics committee of Tabriz University of Medical Sciences Research Vice Chancellor, Third Floor, Central Building No. 2, Tabriz University of Medical Sciences, Golgasht Street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)