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IRCT20210530051441N1 IRCT 2021-06-15 Qazvin University of Medical Sciences Effect of novel combination of herbal extracts in type 2 diabetic patients indices Effect of combination of Chromium, Cinnamon, Urtica, eryngium and D.sophia on glycemic, antioxidant, inflammatory indices, lipid profile and HOMA index in type 2 diabetic patients 2021-06-04 anticipated 60 Complete https://irct.ir/trial/56559 interventional Randomization: Not randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: patients, researchers and statiscal anlyser Individuals are divided into 2 groups of 30 intervention and placebo. Because supplements and placebos are similar in shape, participants and researchers are not aware that placebos or supplements are taken in each group. In the data analysis stage, the analyzer does not know the identity of the groups. 2-3 Condition 1: Diabetes. Condition 2: immune and anti-oxidant system. Intervention 1: Group 1 - Intervention: In this group, patients will receive 100 mg capsules containing herbal extract powder twice a day. The extracts have been purchased and the final combination formulated. Patients will first be interviewed by a trained nutritionist and questionnaires related to the general conditions and anthropometric measurements will be completed. Intervention 2: Group 2 - Placebo: They will receive a capsule containing wheat flour and very similar to the capsules of the intervention group. Yes - There is a plan to make this available What will be shared: The data will be published in the thesis and article When: At most 6 months To whom: It will be available to everyone, such as individuals, scientific institutes, industry Conditions: Thesis data will be made available to students and researchers to use the results of plant extracts on the study variables if necessary. Where to obtain: Published database and valid journals and, By email to the executive and corresponding author: "nutshiri@gmail.com" and cell No. 09143016970, Or refer to the library of Qazvin University of Medical Sciences, Qazvin Bahonar Blvd., Qazvin University of Medical Sciences, telephone number 02833336001 and site address www.qums.ac.ir. How to obtain: By email to the executive and corresponding author: "nutshiri@gmail.com" and cell No. 09143016970, Or refer to the library of Qazvin University of Medical Sciences, Qazvin Bahonar Blvd., Qazvin University of Medical Sciences, telephone number 02833336001 and site address www.qums.ac.ir. Comments:
public Mohammad Reza Shiri Shahsavar
qazvin university of medical scienses, Bahonar blv, qazvin
qazvin Iran (Islamic Republic of) 3419759811 +98 28 3336 9581 nutshiri@gmail.com Qazvin University of Medical Sciences scientific Mohammad Reza Shiri Shahsavar
Qazvin University of Medical Scienses, Bahonar blv, Qazvin
Qazvin Iran (Islamic Republic of) 3419759811 +98 28 3336 9581 nutshiri@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Volunteered Type 2 Diabetes Mellitus (T2DM) age 30 - 60 No change in treatment and medications in at least the last 2 months Average level of physical activity body mass index between 25 and 30 HA1C between 25 and 30 18 years 65 years Both Having diabetes for more than ten years Pregnancy and lactation Hospitalization during the study Patients with severe renal and hepatic impairment and any other acute illness Occurrence of any side effects due to the intervention Menopause and hormone therapy Diet change Changes in the physical activity level Taking any dietary supplement from 2 months before to the end of the study History of any allergies E11 E00–E89 Type 2 diabetes mellitus Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism Treatment - Other Placebo Group 1 - Intervention: In this group, patients will receive 100 mg capsules containing herbal extract powder twice a day. The extracts have been purchased and the final combination formulated. Patients will first be interviewed by a trained nutritionist and questionnaires related to the general conditions and anthropometric measurements will be completed. Group 2 - Placebo: They will receive a capsule containing wheat flour and very similar to the capsules of the intervention group. Fasting Plasma Glucose (FBS). Timepoint: Benign of the study and after 8 weeks in the end of the study. Method of measurement: Biochemistry tests. Plasma insuline. Timepoint: Benign of the study and after 8 weeks in the end of the study. Method of measurement: Biochemistry tests. Qazvin University of Medical Sciences Approved 2020-04-25 qazvin university of medical sciences qazvin university of medical sciences, bahanor blv. qazvin iran qazvin Qazvin Iran (Islamic Republic of)