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IRCT20211116053081N1 IRCT 2022-09-13 Raja University The effect of two therapeutic methods of regular aerobic exercise and Eryngium billardieri extract on type 2 diabetes patients Comparison of six weeks of regular aerobic exercises with hydroalcoholic extract of Eryngium billardieri plant with aerobic exercises on fasting blood sugar and betatrophin serum levels in type 2 diabetic patients. 2022-09-23 anticipated 45 Complete https://irct.ir/trial/65707 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: After selecting the eligible subjects, they will be randomly divided into three groups. To place each subject in one of the three groups, a lottery will be done in Excel in such a way that the names of all qualified people will be entered in a column in Excel, and finally, the RAND and RANDBETWEEN functions will be used to randomly select the subjects in the groups. will be used. Then the subjects will be placed in one of the following groups. 1- The group of taking hydroalcoholic extract of eryngium billardieri along with aerobic exercises. 2- The group of aerobic exercises. 3- The control group. 1-2 Type 2 diabetes. Intervention 1: Intervention group 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 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: Not using eryngium billardieri extract and aerobic exercises. 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) 5981134197 +98 28 3333 6001 Mr.shiri@qums.ac.ir Qazvin University of Medical Sciences scientific Zohreh Eskandari
Qazvin University of Medical Sciences, Nawab Street, Ghazvin
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 - Drugs Other Intervention group 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 group 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. Control group: Not using eryngium billardieri extract and aerobic exercises Blood sugar. Timepoint: Beginning and end of the sixth week of study. Method of measurement: Serum blood (ELISA). Betatrophin serum levels. Timepoint: Beginning and end of the sixth week of stud. Method of measurement: By ELISA method using kit ( ZEllBIO GmbH). Raja University Approved 2022-07-06 Ethics Committee of Ghazvin University of Medical Sciences Shahid Bahonar Boulevard, Ghazvin Ghazvin Qazvin Iran (Islamic Republic of)