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IRCT20211116053081N2 IRCT 2022-10-16 Raja University The effect of Eryngium Billardieri plant and aerobic exercise in diabetes ندارد The effect of consumption of hydro-alcoholic extract of Eryngium Billardieri with aerobic exercise on blood level and lipid profile in type 2 diabetic patients 2022-10-23 anticipated 45 Complete https://irct.ir/trial/65575 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: Among the available patients (patients referred to Mohammadzadeh Clinic located in Qazvin city), 45 subjects will be selected and will be randomly assigned to two intervention groups and one control group through the rand function of Excel software. The method of using this software is as follows: in cells A2:A46, we enter all the names of 45 participants. Then we copy RAND formula in cells B2:B46: =RAND() Then we put the following formula in cell C2:C46 to extract a random value from column A: =INDEX(SAS2:SAS46,RANK(B2,SBS2:SBS46),1) Fifteen initial names of cell C in the first experimental group, 15 middle names of cell C in the second experimental group, and 15 last names of cell C in the third group (in cell C, the names of cell A are placed randomly for For example, the person who is in cell A10 is now in cell C2). 1-2 Type 2 diabetes. Intervention 1: Receiving 100 mg capsules of eryngium billardieri twice a day in the morning and in the evening and aerobic exercises for six weeks, 5 days a week, 60 minutes every day with an average intensity of 50% to 75% of the maximum oxygen consumption. Intervention 2: Intervention group: aerobic exercises for six weeks, 5 days a week, 60 minutes every day with an average intensity of 50% to 75% of the maximum oxygen consumption. Intervention 3: Control group: Failure to receive eryngium billardieri and aerobic exercise, receiving blood sugar control drugs, metformin and sulfonylurea group drugs (Glybanglamid-Glyclazide, etc.). No - There is not a plan to make this available Justification or reason for not sharing IPD is I have no justification
public Mohammad Reza Shiri Shahsavar
Qazvin University of Medical Sciences, Nawab Street, Qazvin
Ghazvin Iran (Islamic Republic of) 3414763803 +98 28 3333 6001 Mr.shiri@qums.ac.ir Qazvin University of Medical Sciences scientific Zohreh Eskandari
Qazvin University of Medical Sciences, Nawab Street, Qazvin
Ghazvin Iran (Islamic Republic of) 3414763803 +98 28 3369 1975 z.eskandari@raja.ac.ir Qazvin University of Medical Sciences Iran (Islamic Republic of) Age range 35 to 60 Suffering from type 2 diabetes Having fasting blood sugar between 150 and 200 mg/dL Using metformin and sulfonylurea group drugs (Glibenglamid, gliclazide, etc.) to control blood sugar Following the diet given by the nutritionist Not using any medicinal plants other than Eryngium Billardieri during the research 35 years 60 years Both Having regular physical activity (more than two sessions per week) during the last six months Inability to perform aerobic exercises due to physical diseases such as atherosclerosis, orthopedic problems, etc. Having diseases other than diabetes such as blood pressure, cardiovascular diseases and thyroid diseases E11.9 Type 2 diabetes mellitus Treatment - Drugs Treatment - Other N/A Receiving 100 mg capsules of eryngium billardieri twice a day in the morning and in the evening and aerobic exercises for six weeks, 5 days a week, 60 minutes every day with an average intensity of 50% to 75% of the maximum oxygen consumption. Intervention group: aerobic exercises for six weeks, 5 days a week, 60 minutes every day with an average intensity of 50% to 75% of the maximum oxygen consumption. Control group: Failure to receive eryngium billardieri and aerobic exercise, receiving blood sugar control drugs, metformin and sulfonylurea group drugs (Glybanglamid-Glyclazide, etc.) Blood glucose. Timepoint: The beginning and the sixth week of study. Method of measurement: Serum blood (ELISA). Lipid profile. Timepoint: The beginning and the sixth week of study. Method of measurement: Autoanalyzer method. Raja University Approved 2022-07-06 Qazvin University of Medical Sciences Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Ghazvin Ghazvin Qazvin Iran (Islamic Republic of)