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IRCT20161031030616N2 IRCT 2022-03-15 Gorgan University of Medical Sciences Evaluation of the effect of Pistacia atlantica on fasting blood sugar in patients with type 2 diabetes Evaluation of the effect of Pistacia atlantica oleoresin on fasting blood sugar in patients with type 2 diabetes and its relationship with lipid profile and blood pressure A randomized, single-blind, placebo-controlled trial 2022-04-09 anticipated 42 Complete https://irct.ir/trial/62344 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: In this study, the allocation of samples to the study groups will be stratified randomization. Because variables such as the presence of a history of disease (diabetes and hypertension) and gender have been identified as confounding variables in the study results according to the studies, the researcher decided to control the samples for the above variables and balance between Establish groups. Because in this study, samples will be available in the study, the researcher will also consider the matching of the studied groups in terms of the above variables when assigning samples to groups according to the permutation block method. After the number of samples in both groups reached half of the estimated number of samples, the groups were examined to ensure that matching occurred. By first selecting one of the 6 permutations (AABB-ABAB-ABBA-BAAB-BABA-BBAA) by simple random sampling without placement according to the selected block (eg AABB) Group A and the second sample with a history of disease and gender will be assigned to group A and the third and fourth samples with a history of disease and gender will be assigned to group B. In the second stage, one of the blocks will be selected and the samples will be assigned to the groups according to their permutations, and this process will continue until the required half of the sample in each group is reached. Confusing variables will be checked. If matching has occurred, the process of assigning samples to groups will continue. If no matching is performed, the simple random randomization to groups will continue, Blinding description: In this study, blinding will be one-sided blind. In this way, patients will not be aware of being in two groups and drugs will be prepared in identical forms (in terms of color, smell, and taste) in the form of capsules for both groups. At the time of assigning the samples to the study groups, the participating samples are not aware of which group of the present study they are in, and only the assignor according to the block permutations and the type of letters (A, B) assigned to each sample, Knows which group (group A or group B) the sample is in. 3 Diabetes mellitus. Intervention 1: In this study, 42 patients were selected and divided into two groups of control and case, each group of 21 people.In this study, the allocation of samples to the study groups will be stratified randomization. In the intervention group, they will receive Pistacia atlantica oleoresin capsules in a dose of 500 mg twice a day for three consecutive months, in addition to a hypoglycemic drug (metformin tablets).The drug will be delivered to patients monthly.Before the start of the study, fasting blood sugar tests, 2hpp BS, Hb A1C and serum lipids are measured and then patients are included in the study.Then, after 3 months, a blood test is taken again and all 3 factors of fasting blood sugar, 2hpp BS, Hb A1C and serum lipids are measured. Intervention 2: Control group: 21 patients will be in the control group. anti diabetic drug (metformin tablets) for three months.In this study, the allocation of samples to the study groups will be stratified randomization. drugs will be delivered to patients on a monthly basis.Before the start of the study, fasting blood sugar tests, 2hpp BS, Hb A1C and serum lipids are measured and then patients are included in the study.Then, after 3 months, a blood test is taken again and all 3 factors of fasting blood sugar, 2hpp BS, Hb A1C and serum lipids are measured. 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 more information.
public Fatemeh Kolangi
School of Medicine, Golestan University of Medical Sciences, Gorgan, Iran
Gorgan Iran (Islamic Republic of) 4934174515 +98 17 3243 0310 dr.kolaangi@gmail.com Gorgan University of Medical Sciences scientific Fatemeh Kolangi
School of Medicine, Golestan University of Medical Sciences, Gorgan, Iran
Gorgan Iran (Islamic Republic of) 4934174515 +98 17 3243 0310 dr.kolaangi@gmail.com Gorgan University of Medical Sciences Iran (Islamic Republic of) The patient's desire to enter the study Age between 30-64 years, whose definitive diagnosis of diabetes has been made by performing two FBS tests more than 126 and the approval of the relevant specialist. Patients with a history of type 2 diabetes are diagnosed less than two years after the onset of the disease and use at least one standard oral medication (metformin tablets) for initial control of the disease. HbA1c is more equal to 8% and less than 9%. 30 years 64 years Both blood sugar more than 300 and HbA1c is more equal to 9% . Have indications for starting insulin and other injectable therapy. Patients treated with insulin Moderate to severe renal insufficiency (GFR less than 45 or albuminuria more than 300 mg) Liver failure (diagnosis by an internal medicine specialist or gastroenterologist based on bilirubin, albumin and liver enzymes) Class 3 and 4 heart failure Diabetic retinopathy Serious medical illness Simultaneous infectious diseases including pulmonary tuberculosis, diabetic foot ulcers and ... High blood pressure (systolic above 160 or diastolic above 100 mm Hg) or need to take more than three antihypertensive drugs Women who decide to get pregnant Pregnant women and lactating women E11 Diabetes mellitus due to underlying condition Treatment - Drugs Treatment - Drugs In this study, 42 patients were selected and divided into two groups of control and case, each group of 21 people.In this study, the allocation of samples to the study groups will be stratified randomization. In the intervention group, they will receive Pistacia atlantica oleoresin capsules in a dose of 500 mg twice a day for three consecutive months, in addition to a hypoglycemic drug (metformin tablets).The drug will be delivered to patients monthly.Before the start of the study, fasting blood sugar tests, 2hpp BS, Hb A1C and serum lipids are measured and then patients are included in the study.Then, after 3 months, a blood test is taken again and all 3 factors of fasting blood sugar, 2hpp BS, Hb A1C and serum lipids are measured. Control group: 21 patients will be in the control group. anti diabetic drug (metformin tablets) for three months.In this study, the allocation of samples to the study groups will be stratified randomization. drugs will be delivered to patients on a monthly basis.Before the start of the study, fasting blood sugar tests, 2hpp BS, Hb A1C and serum lipids are measured and then patients are included in the study.Then, after 3 months, a blood test is taken again and all 3 factors of fasting blood sugar, 2hpp BS, Hb A1C and serum lipids are measured. FBS. Timepoint: At the beginning of the study (before the intervention) and At the end of three months from the start of the intervention. Method of measurement: Calorimetric by enzymatic method. Two-hour blood sugar. Timepoint: At the beginning of the study (before the intervention) and At the end of three months from the start of the intervention. Method of measurement: Calorimetric by enzymatic method. HbA۱C. Timepoint: At the beginning of the study (before the intervention) and At the end of three months from the start of the intervention. Method of measurement: chromatography. Blood serum cholesterol level of patients. Timepoint: At the beginning of the study (before the intervention) and At the end of three months from the start of the intervention. Method of measurement: Calorimetric by enzymatic method. Blood serum triglyceride level of patients. Timepoint: At the beginning of the study (before the intervention) and At the end of three months from the start of the intervention. Method of measurement: Calorimetric by enzymatic method. Blood serum LDL cholesterol level of patients. Timepoint: At the beginning of the study (before the intervention) and At the end of three months from the start of the intervention. Method of measurement: Calorimetric by enzymatic method. Blood serum HDL cholesterol level of patients. Timepoint: At the beginning of the study (before the intervention) and At the end of three months from the start of the intervention. Method of measurement: Calorimetric by enzymatic method. Systolic blood pressure. Timepoint: At the beginning of the study (before the intervention) and At the end of three months from the start of the intervention. Method of measurement: Blood pressure device. Diastolic blood pressure. Timepoint: At the beginning of the study (before the intervention) and At the end of three months from the start of the intervention. Method of measurement: Blood pressure device. Gorgan University of Medical Sciences Approved 2022-02-27 Ethics Committee of Golestan University of Medical Sciences Phalsaphy complex, Shast kola Road Gorgan Golestan Iran (Islamic Republic of)