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Study aim
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Determine the effects of a herbal compound on the level of diabetes mellitus that can be used as a complementary therapy in diabetic patients.
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Design
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In this study, 60 males and females with type 2 diabetes who are eligible to enter the study are selected. Participants are randomly divided into two intervention and control groups and assigned a code to hide the intervention group of each participant.
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Settings and conduct
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This clinical trial will be carried out before and after 60 men and women with type 2 diabetes. At the beginning of the study, patients receive fasting blood samples and their total cholesterol, LDL, VLDL, HDL, triglyceride, fasting blood glucose, hemoglobin glycosylated, liver enzymes, BUN, creatinine are examined. Patients are asked to take a tablespoon of herbaceous saccharine for 2 months. Fasting venous blood samples are tested at the end of the first month. Blood parameters will be measured using common kits in the market and autoanalysers. Patients participating in the research will not pay for the cost of the herb, visits, and tests. The third party encodes as experts, patients and medications so that the participant will be assigned to the allocation of clinical and clinical care groups to the patient and blind drug compounds.
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Participants/Inclusion and exclusion criteria
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The participants are 60 males and females with type 2 diabetes.
Patients who are at high risk for not controlling glucose with a fixed dose of drug are excluded from this study.
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Intervention groups
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Patients are asked to mix and take a tablespoon of herbal combination on a daily basis, twice before (before lunch and before dinner) with a glass of water and dough. A common diet for people with diabetes continues throughout the study. There is also a control group. In both groups, the usual hypoglycemic agents will continue throughout the study as in the previous procedure. Patients will be visited during the first week, and vital signs, glucose and possible side effects will be investigated. Fasting venous blood samples are tested at the end of the first month
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Main outcome variables
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TG, cholesterol, VLDL, HDL, LDL, fasting blood glucose, blood glucose two hours after food, glycosylated hemoglobin ALT, AST, blood creatinine, BUN.