The effect of combination of Eryngium Billardieri and Boswellia serrata extracts on blood glucose, insulin, fasting insulin resistance index, lipid profile, and liver enzymes in type II diabetes patients

The effect of combination of Eryngium Billardieri and Boswellia serrata extracts on blood glucose, insulin, fasting insulin resistance index, lipid profile, and liver enzymes in type 2 diabetes patients

The clinical trial has a control group, with parallel groups, double-blind, randomized, phase 2 on 60 type 2 diabetic patients. Excel software rand function was used for randomization.

We select 60 patients with type 2 diabetes referred to the Diabetes Center of Golestan Hospital in Ahvaz and randomly divide them into two groups.

Inclusion criteria: Age 50-35; only take oral medications; having fasting sugar above 140; willingness to participate in the study. Exclusion criteria: patients with liver cirrhosis; pregnant and lactating women; smoking and alcohol use; patients with retinopathy; people with active kidney disease; congestive heart failure and heart attack in the last six months; take insulin and other supplements.

Intervention group 1(experimental group): using a drug made from the extract of Eryngium Billardieri and Boswellia serrata, which is about twenty-one milliliters (one-third is frankincense resin and two-thirds is borage) in addition to routine drugs. The second group (control group): placebo in addition to routine drugs.

Determination of fasting blood sugar and insulin levels, insulin resistance indices, insulin sensitivity, triglycerides, cholesterol, low-density lipoprotein, high-density lipoprotein, alkaline phosphatase, aspartate aminotransferase and alanine aminotransferase

The randomization list is prepared by someone who is not in the study. The method of randomization will be based on the method of "randomization of balanced blocks", in which the number of people who will participate in the study, in order of entry into the study, are divided into blocks whose size is determined by the person. This number will remain hidden so that the people in the study are not aware of the size of the blocks. Assignment of each person in each block is done equally between the two groups by generating random numbers in Excel software. For example, if the block size is 4, in Excel software, 4 codes A and 2 codes B are written in 4 rows, and a random number is created in front of each of them, and by arranging these 4 rows based on random numbers, the codes are created. A and B will be randomly assigned to the members of this special block. This is done for other blocks as well. Assignment of codes A and B to the intervention and placebo will be done randomly by a third party and will be reopened after analyzing the data and summarizing the results. The third party writes numbers from one to n (sample size) on the chewing gum packages based on a random allocation list, so that study participants and researchers will be unaware of the contents of the packages and groupings A and B. . The random allocation list will be opened after the data collection is completed to identify the two study groups for statistical analysis.

Code "A" and "B" will be assigned to each person in the study, and only the researcher will be aware of the type of groups. Clinical caregivers and participants are unaware of the groups. It should be noted that the extract is made and the placebo is similar in appearance, color and packaging.

Only part of the data, such as glucose and lipid profile information, can be shared after identifying individuals.

All this data is available in the article and everyone has access to it by preparing the complete file of the article.

All this data is available in the article and everyone has access to it by preparing the complete file of the article.

This data can be used by all people who study medicinal plants.

To receive this data, you can correspond with the email of the project manager.

To get the data, you can correspond with the executor of the project by email, and after checking the correspondence, the data will be provided to the person in an unrecognizable manner.