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IRCT2016100630175N1 IRCT 2017-01-15 Research and Technology Vice-Chancellory of Mashhad University of Medical Sciences The effect of caper oxymel on loosing weight, decressing blood suger and blood fat and lowering blood pressure in diabetic patients Study of oxymel caper product on metabolic syndrom diagnostic indexes in patients with diabetes type 2 2016-11-21 anticipated 42 Complete https://irct.ir/trial/24063 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2 Diabete. Intervention 1: Intervention group1: Caper oxymel including 2000 mg hydroalcoholic extraction of capparis spinosa in oxymel 30 cc per day orally in 2-3 divided doses for 3 month. Intervention 2: Intervention group2: Simple suger oxymel 30 cc per day orally in 2-3 divided doses for 3 month. Intervention 3: Control group: Dextrose syroup (65%), 30 cc per day, orally in 2-3 divided doses for 3 month.
public Hamideh Vahid
Faculty of Iranian Traditional Medicine and Complementary, Opposite the Mehran sports hall, East Razi Ave.
Mashhad Iran (Islamic Republic of) +98 51 3855 2188 tim@mums.ac.ir؛ vahidh2@mums.ac.ir Faculty of Iranian Traditional Medicine and Complementary of Mashhad University of Medical Sciences scientific Mahdi Yousefi
Faculty of Iranian Traditional Medicine and Complementary, Opposite the Mehran sports hall, East Razi Ave.
Mashhsd Iran (Islamic Republic of) +98 51 3855 2188 tim@mums.ac.ir؛ yousefim@mums.ac.ir Faculty of Iranian Traditional Medicine and Complementary of Mashhad University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Diabetic patients (type 2) whose disease has not been controlled inspit of taking complete oral medication based on ADA and they do not accept to take insulin؛ Ages between 30-65 years old؛ Definitive diagnosis of metabolic syndrom based on NECP:ATPIII diagnostic criteria exclusion criteria: Dissatisfaction with continuing participation؛ Necessity of any new therapeutic intervension during the study based on endocrinologist؛ Breast feeding and lactation؛ Complications such as increasing blood presure, chest pain, fatigue during treatment؛ Renal problem with increasing creatinine and decreasing GFR less than 60؛ Any systematic disease which influence on trend of disease such as cardiac diseases, liver problems and malignancies؛Acute or sever complications of diabete such as DKA, hyperosmolar coma and sever hypoglycemia in recent 3 months؛ The critical illness which leads to hospitalisation in recent 3 months؛ Taking hyperglycemic agent such as immunosupressive and antileptic 30 years 50 years Both E11 Non-insulin-dependent diabetes mellitus Treatment - Drugs Treatment - Drugs Placebo Intervention group1: Caper oxymel including 2000 mg hydroalcoholic extraction of capparis spinosa in oxymel 30 cc per day orally in 2-3 divided doses for 3 month Intervention group2: Simple suger oxymel 30 cc per day orally in 2-3 divided doses for 3 month Control group: Dextrose syroup (65%), 30 cc per day, orally in 2-3 divided doses for 3 month Waist circumference. Timepoint: Before in intervention, one month, two month and after intervention. Method of measurement: Using a tape in order to measure in cm. Fasting blood suger. Timepoint: Before in intervention, one month, two month and after intervention. Method of measurement: Measuring by blood tests in mg/dl. Lipid profil. Timepoint: Before and after intervention. Method of measurement: Measuring by blood tests in mg/dl. HbA1c. Timepoint: Before and after intervention. Method of measurement: Measuring by blood tests in %. Blood pressure. Timepoint: Before in intervention, one month, two month and after intervention. Method of measurement: Measuring by sphygmomanometer in mm/hg. Microalbuminuria. Timepoint: Before and after intervention. Method of measurement: Measuring by urine tests in mg/l. CRP. Timepoint: Before and after intervention. Method of measurement: Measuring by blood tests in mg/l. SGOT. Timepoint: Before in intervention, one month, two month and after intervention. Method of measurement: Measuring by blood tests in IU/L. SGPT. Timepoint: Before in intervention, one month, two month and after intervention. Method of measurement: Measuring by blood tests in IU/L. ALP. Timepoint: Before in intervention, one month, two month and after intervention. Method of measurement: Measuring by blood tests in IU/L. Creatinie. Timepoint: Before in intervention, one month, two month and after intervention. Method of measurement: Measuring by blood tests in mg/dl. Research and Technology Vice-Chancellory of Mashhad University of Medical Sciences Approved 2016-10-08 Ethics committee of Mashhad University of Medical Sciences Mashhad University of Medical Sciences Administration, Building Qureshi, Daneshgah Ave. Mashhad Iran (Islamic Republic of)