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IRCT20191229045937N1 IRCT 2020-02-02 Ahvaz University of Medical Sciences The Effect of Combined Supplementation of Berberine and Fenugreek Seed Powder on Inflammatory Factors and Lipid and Glucose Profile in Patients with Type 2 Diabetes Comparison of the combined efficacy of berberine and fenugreek in controlling blood glucose and lipid profile and inflammatory factors in type 2 diabetic patients 2019-12-29 anticipated 50 Complete https://irct.ir/trial/44628 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization Method: Block Randomization Tool: Statistical Software, Blinding description: 1. Split people into 2 groups based on age group randomly blocked using 3-way blocks (split: 25-35 / 35-45 / 45-65). 2. Double blinding blind before coding the set of cans containing capsules and how to use them, coded by a non-researcher as a allocation concealment to ensure that the researcher does not know the type of capsules received. 3 Type 2 diabetes. Intervention 1: Intervention group: We selected 25 patients with type 2 diabetes between the ages of 25-65 years based on inclusion and exclusion criteria. Each person consumes 3 capsules of 500 mg daily (300 mg of berberine + 200 mg of fenugreek seed powder) before three main meals and this intervention lasts 12 weeks. Intervention 2: Control group: We selected 25 patients with type 2 diabetes between the ages of 25-65 years based on inclusion and exclusion criteria. Each person consumes 3 capsules of 500 mg daily (500 mg of wheat flour) before 3 servings and this intervention lasts 12 weeks. Yes - There is a plan to make this available What will be shared: Survey the effect of co-supplementation of berberine and fenugreek seed powder on inflammatory factors glycemic and lipid profile in patients with type 2 diabetes mellitus When: One year and two months To whom: researchist Conditions: Prevention and treatment of people with type 2 diabetes Where to obtain: laboratory How to obtain: Double-blind random sampling Comments:
public Shima Nematollahi
Golestan Medical Sciences Dormitory, Golestan Boulevard, Ahvaz, Khouzestan, Iran
Ahvaz Iran (Islamic Republic of) 6135815751 +98 61 3321 4578 Shimanematollahi7@gmail.com Ahvaz University of Medical Sciences scientific Fatemeh Borazjani
Golestan Boulevard Golestan Medical Sciences Dormitory
Ahvaz Iran (Islamic Republic of) 6135815751 +98 61 3321 4578 fa.borazjani@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Having over 25BMI, at least 1 year of diabetes, 25-65 year olds with type 2 diabetes, taking blood sugar lowering diabetes medications, no pregnancy and lactation, no chronic diseases (liver, kidney, heart, thyroid, Rheumatic, Pulmonary, Metabolic, Digestive, Malignancies, Allergies), No insulin requirement, No use of dietary supplements, vitamins and minerals at least 3 months before study, No hormone therapy, No smoking, No use of other medicinal products Routine face at least 3 months before study, written informed consent from patients at least 1 year of diabetes 25-65 year olds with type 2 diabetes taking blood sugar lowering diabetes medications no pregnancy and lactation no chronic diseases (liver, kidney, heart, thyroid, Rheumatic, Pulmonary, Metabolic, Digestive, Malignancies, Allergies) No insulin requirement No use of dietary supplements, vitamins and minerals at least 3 months before study No hormone therapy No smoking No use of other medicinal products Routine face at least 3 months before study written informed consent from patients 25 years 65 years Both Not willing to continue cooperation Specific diseases (liver, kidney, heart, thyroid, rheumatic, pulmonary, metabolic, gastrointestinal, malignant, allergic) during study pregnancy initiation and lactation Start insulin treatment Start taking supplements, vitamins and minerals Changes in the dosage of oral hypoglycemic agents Changes in the amount of physical activity during the study Start taking other medicinal products routinely Pregnant and lactating women Past 6 months drug or alcohol use history Taking steroidal anti-inflammatory drugs and fiber supplements Weight loss diet at least 6 months before the intervention Use of dietary supplements and other herbal remedies at least 3 months before intervention E08 Diabetes mellitus due to underlying condition Treatment - Drugs Treatment - Drugs Intervention group: We selected 25 patients with type 2 diabetes between the ages of 25-65 years based on inclusion and exclusion criteria. Each person consumes 3 capsules of 500 mg daily (300 mg of berberine + 200 mg of fenugreek seed powder) before three main meals and this intervention lasts 12 weeks Control group: We selected 25 patients with type 2 diabetes between the ages of 25-65 years based on inclusion and exclusion criteria. Each person consumes 3 capsules of 500 mg daily (500 mg of wheat flour) before 3 servings and this intervention lasts 12 weeks. Inflammatory factors and lipid and sugar profiles. Timepoint: Evaluation of inflammatory factors and lipid profile and glucose profile at baseline and 12 weeks after starting supplementation with berberine and fenugreek. Method of measurement: Blood serum separation. Ahvaz University of Medical Sciences Approved 2019-12-28 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Golestan Medical Sciences Dormitory, Golestan Boulevard, Ahvaz, Khouzestan, Iran Ahvaz Khouzestan Iran (Islamic Republic of)