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IRCT20111225008515N4 IRCT 2022-01-15 Ahvaz University of Medical Sciences "The effect of combination of Eryngium Billardieri and Boswellia serrata extracts on diabetes" 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 2022-01-19 anticipated 60 Complete https://irct.ir/trial/61026 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 2 type 2 diabets. Intervention 1: Intervention group 1:In addition to routine medications, patients in this group are treated with extracts of Eryngium Billardieri and Boswellia serrata for 4 weeks. This combination is about twenty-one cc; One third of it is Boswellia serrata resin (about 7 cc) and two thirds of it is Eryngium Billardieri extract (about 14 cc) and is consumed after lunch. Intervention 2: Control group: This group, which is the control group, also receives placebo in addition to routine medications (for 4 weeks after lunch). Yes - There is a plan to make this available What will be shared: Only part of the data, such as glucose and lipid profile information, can be shared after identifying individuals. When: All this data is available in the article and everyone has access to it by preparing the complete file of the article. To whom: All this data is available in the article and everyone has access to it by preparing the complete file of the article. Conditions: This data can be used by all people who study medicinal plants. Where to obtain: To receive this data, you can correspond with the email of the project manager. How to obtain: 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. Comments:
public Sorour Rajabalipour
Esfand Ave, Golestan Blv
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3391 0443 Sorourrajabalipour@gmail.com Ahvaz University of Medical Sciences scientific Akram Ahangarpour
Esfand Ave, Golestan Blvd
Ahvaz Iran (Islamic Republic of) 6155776851 +98 61 3337 2712 akramahangarpour@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Only take oral medications and do not take insulin and other supplements Having 250-140 fasting sugar Patients' willingness to participate in the study 35 years 50 years Both Patients with liver cirrhosis Pregnant and lactating women Smoking and alcohol use Patients with active retinopathy and proliferative People with active kidney disease Congestive heart failure and heart attack in the last six months E08 Diabetes mellitus due to underlying condition Treatment - Drugs Placebo Intervention group 1:In addition to routine medications, patients in this group are treated with extracts of Eryngium Billardieri and Boswellia serrata for 4 weeks. This combination is about twenty-one cc; One third of it is Boswellia serrata resin (about 7 cc) and two thirds of it is Eryngium Billardieri extract (about 14 cc) and is consumed after lunch. Control group: This group, which is the control group, also receives placebo in addition to routine medications (for 4 weeks after lunch). Fasting blood sugar above 140. Timepoint: Beginning and end of the study. Method of measurement: Using a glucometer. Ahvaz University of Medical Sciences Approved 2021-12-24 Ethics Committees of Ahvaz Jundishapur University of Medical Sciences Esfand Ave, Golestan Blvd Ahvaz Khouzestan Iran (Islamic Republic of)