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IRCT201503071157N10 IRCT 2016-05-15 Vice chancellor for research, Institute of Medicinal Plants Effect of herbal extract mixture on treatment of diabetes Effect of herbal antidiabetic capsule on blood sugar control in type 2 diabetic patients 2016-04-29 anticipated 150 Complete https://irct.ir/trial/259 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study 150 patients are randomly divided into herbal drug, placebo and control groups encoded with alphabet A, B,C. Block randomization with a computer generated random numbers table and sequentially numbered containers each representing a block consisting of three patients are used for the treatment assignments. Three different persons generate the random allocation sequence, enroll the participants and assign them to interventions. Care providers, participants and the person evaluating the response to treatments are blind to the interventions. 2 Diabetes. Intervention group: Herbal extract capsule (500 mg) will be administered 2 times a day orally for 3 months. Control group: Metformin capsule (250 mg) mixed with toast powder (250 mg) will be administered 2 times a day orally for 3 months. Placebo group: Placebo capsule (500 mg toast powder) will be administered 2 times a day orally for 3 months..
public Hasan Fallah Huseini
Kavosh Boulevard, Supa Boulevard, 55th km of Tehran-Qazvin Highway, Research Complex of Jahad Daneshgahi
Karaj Iran (Islamic Republic of) 13601360 +98 263476401020 huseini_fallah@yahoo.com Institute of Medicinal Plants scientific Hasan Fallah Huseini
Kavosh Boulevard, Supa Boulevard, 55th km of the Tehran-Qazvin Highway, Research Complex of Jahad Daneshgahi
Karaj Iran (Islamic Republic of) 13601360 +98 263476401020 huseini_fallah@yahoo.com Institute of Medicinal Plants Iran (Islamic Republic of) Inclusion criteria:Type 2 diabetic patients; aged 40 to 60 years; fasting blood glucose levels from 130 to 160 mg/dL; blood glycosylated hemoglobin levels from 7.5 to 8.5 percent; under oral anti-hyperglycemic drugs therapy taking maximum1000 mg metformin and 10 mg glybencalamid daily. Exclusion criteria: Patients receiving insulin therapy; patients with cardiovascular, renal, hepatic, hematological, hypothyroidism, vertigo and seizure diseases; patients with a history of gallstones or gallbladder surgery; patients under estrogen, steroid, beta-blocker and thiazide therapy; women planning for pregnancy; pregnant women; breast-feeding women. 40 years 60 years Both E10, E14, Non-insulin-dependent diabetes mellitus Treatment - Drugs Intervention group: Herbal extract capsule (500 mg) will be administered 2 times a day orally for 3 months. Control group: Metformin capsule (250 mg) mixed with toast powder (250 mg) will be administered 2 times a day orally for 3 months. Placebo group: Placebo capsule (500 mg toast powder) will be administered 2 times a day orally for 3 months. Glucose. Timepoint: At starting of the study and after 3 months. Method of measurement: Blood glucose level will be determined in laboratory by commercial standard kit. Glycosylated hemoglobin (HbA1c). Timepoint: At starting of the study and after 3 months. Method of measurement: HbA1c percent will be determined in laboratory by commercial standard kit. Triglyceride. Timepoint: At starting of the study and after 3 months. Method of measurement: Blood triglyceride level will be determined in laboratory by commercial standard kit. Cholesterol. Timepoint: At starting of the study and after 3 months. Method of measurement: Blood cholesterol level will be determined in laboratory by commercial standard kit. Low-density lipoprotein (LDL). Timepoint: At starting of the study and after 3 months. Method of measurement: Blood LDL level will be determined in laboratory by commercial standard kit. High-density lipoprotein (HDL). Timepoint: At starting of the study and after 3 months. Method of measurement: Blood HDL level will be determined in laboratory by commercial standard kit. Aspartate aminotransferase (AST). Timepoint: At starting of the study and after 3 months. Method of measurement: Blood AST level will be determined in laboratory by commercial standard kit. Alanine aminotransferase (ALT). Timepoint: At starting of the study and after 3 months. Method of measurement: Blood ALT level will be determined in laboratory by commercial standard kit. Blood urea nitrogen (BUN). Timepoint: At starting of the study and after 3 months. Method of measurement: Blood BUN level will be determined in laboratory by commercial standard kit. Creatinine. Timepoint: At starting of the study and after 3 months. Method of measurement: Blood creatinine level will be determined in laboratory by commercial standard kit. Vice chancellor for research, Institute of Medicinal Plants Approved 2015-11-17 Ethics Committee of Avicenna Research Institute Shahid Beheshti University, Tabnak Street, Shahid Chamran Highway, Evin, Tehran. IRAN Tehran Iran (Islamic Republic of)