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IRCT2016081312438N21 IRCT 2017-01-12 Kashan University of Medical Sciences Effect of Morus Alba leaves’s extract supplement on type 2 diabetes Effect of Morus Alba leaves’s extract supplement on blood glucose, lipid profiles, HbA1c, insulin resistance ,inflammation factors and oxidative stress biomarkers in patients with type 2 diabetes 2016-11-21 anticipated 60 Complete https://irct.ir/trial/12509 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomized based on table of random numbers, Randomization description: Computer-generated random numbers will be utilized for random assignment. Clinic-trained personnel will be performed all participant enrollment, random allocation and group assignment, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules. 3 Diabets type 2. Intervention 1: Intervention group:300 mg Morus Alba leaves’s extract capsule, twice a day; 12 weeks; produced by Barij esans Co, Kashan, Iran. Intervention 2: Control group: Placebo capsule; twice a day; 12 weeks; produced by Barij esans Co, Kashan, Iran. 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 There is no decision for this matter.
public Dr.M. Taghizadeh
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8715973474 +98 86 4446 5112 mohsenta44@yahoo.com Barij Research Center of Medicinal Herbs scientific Dr.Z.Asemi
Kashan University Of Medical Sciences, Kashan
Kashan Iran (Islamic Republic of) 8715973474 +98 31 5554 0021 asemi_z@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Patients with type 2 diabetes mellitus Aged 35–70 years 35 years 70 years Both Mulberry extract intake in the last three months Changing in glucose-lowering medications Taking anticoagulants during the study Pregnancy or lactating Malignancies Chronic hepatic diseases E11 Non-insulin-dependent diabetes mellitus Treatment - Drugs Placebo Intervention group:300 mg Morus Alba leaves’s extract capsule, twice a day; 12 weeks; produced by Barij esans Co, Kashan, Iran. Control group: Placebo capsule; twice a day; 12 weeks; produced by Barij esans Co, Kashan, Iran. HOMA-IR. Timepoint: Before the beginning of the study and 12 weeks after. Method of measurement: Calculated with HOMA formula. Fasting plasma glucose (FPG). Timepoint: Before the beginning of the study and after 12 weeks. Method of measurement: Enzymatic. Insulin. Timepoint: Before the beginning of the study and after 12 weeks. Method of measurement: ELISA. QUICKI. Timepoint: Before the beginning of the study and after 12 weeks. Method of measurement: Calculated with formula. HbA1C. Timepoint: Before the beginning of the study and after 12 weeks. Method of measurement: Immunofluorescence. Triglycerides. Timepoint: Before the beginning of the study and after 12 weeks. Method of measurement: Enzymatic. Very low density lipoptotein (VLDL)-Cholesterol. Timepoint: Before the beginning of the study and after 12 weeks. Method of measurement: Enzymatic. Cholesterol. Timepoint: Before the beginning of the study and after 12 weeks. Method of measurement: Enzymatic. Low density lipoptotein (LDL)-Cholesterol. Timepoint: Before the beginning of the study and after 12 weeks. Method of measurement: Enzymatic. High density lipoptotein (HDL)-Cholesterol. Timepoint: Before the beginning of the study and after 12 weeks. Method of measurement: Enzymatic. Alanine transaminase (ALT). Timepoint: Before the beginning of the study and after 12 weeks. Method of measurement: Enzymatic. Aspartate transaminase (AST). Timepoint: Before the beginning of the study and after 12 weeks. Method of measurement: Enzymatic. C reactive protein (CRP). Timepoint: Before the beginning of the study and after 12 weeks. Method of measurement: ELISA. Nitric oxide (NO). Timepoint: Before the beginning of the study and after 12 weeks. Method of measurement: Spectrophotometry. Total antioxidant capacity (TAC). Timepoint: Before the beginning of the study and after 12 weeks. Method of measurement: Spectrophotometry. Glutathione (GSH). Timepoint: Before the beginning of the study and after 12 weeks. Method of measurement: Spectrophotometry. Malondialdehyde (MDA). Timepoint: Before the beginning of the study and after 12 weeks. Method of measurement: Spectrophotometry. Kashan University of Medical Sciences Approved 2016-09-28 Ethics committee of Kashan University of Medical Sciences Kashan University Of Medical Sciences, Kashan Kashan Isfehan Iran (Islamic Republic of)