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

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

Clinical trial with control group,single blind, randomized, phase 3 on 42 patients. In this study, the allocation of samples to the study groups will be stratified randomization.

This study is performed on patients referred to Deziani Diabetes Clinic with a definitive diagnosis of type 2 diabetes. In this study, 42 patients were selected and randomly divided into two groups of control and case, each group of 21 people. In the intervention group, Pistacia atlantica oleoresin capsules in a dose of 500 mg twice a day for three consecutive months, in addition to blood sugar lowering drug (metformin tablets) will be received. In the control group, they will only receive blood sugar-lowering drug (metformin tablets) for three consecutive months.

Inclusion criteria: Age between 30-64 years, whose definitive diagnosis of diabetes Patients with a history of type 2 diabetes HbA1c is more equal to 8% and less than 9%. Exclusion criteria: blood sugar more than 300 and HbA1c is more equal to 9% . indications for starting insulin Moderate to severe renal insufficiency (GFR less than 45 or albuminuria more than 300 mg) Liver failure

In Intervention group: Pistacia atlantica oleoresin capsules at a dose of 500 mg twice a day for three months, in addition to the anti diabetic drug (metformin tablets). In the control group, they will only use the blood sugar-lowering drug (metformin tablets) for three months.

FBS, 2HPP BS, HbA۱c

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.

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.