Evaluation of the effect of Neem extract on Glycemic control, endothelial dysfunction and biomarkers and platelet aggregation in Pre-diabetic subjects - Prediabetes

Dr K Sireesha0 个研究点目标入组 60 人开始时间: 待定最近更新: 2023年11月13日

试验速览

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•1.Male and female subjects between 25-55 years will be recruited as per the American Diabetes Association (ADA) definition for prediabetes condition.
•2. Subjects with BMI = 25 kg/m2.
•3.Subjects with impaired fasting glucose defined as fasting blood glucose of 100-125 mg/dl.
•4.Subjects with impaired oral glucose tolerance test (OGTT) defined as 2 hours blood glucose during 75-grams OGTT levels between 140-199 mg/dL.
•5.Glycosylated hemoglobin (HbA1c) = 5.7% to < 6.4%
•6.Subjects with endothelial dysfunction – (salbutamol challenge test) documented as decrease in RI index by <6%.
•7.Subjects not on any investigational products in the past 6 months.

•1. Subjects with abnormal biochemical parameters considered significant by investigator.
•2. Subjects with diagnosis of diabetes.
•3. Uncontrolled hypertension (SBP >140mmHg and DBP >90mmHg).
•4. Serum Triglycerides >250mg/dL and HDL < 35 mg/dL.
•5. AST and ALT elevation >3 times upper limit of normal.
•6. Serum creatinine more than 1.5 mg/dl.
•7. On any other dietary or herbal supplements.
•8. Diagnosis of Cardiovascular disorders, CNS disorders, diagnosis of neoplasia/malignancy, autoimmune disorders, major depression and other psychiatric conditions or any current degenerative, inflammatory and infectious disease that may affect outcome of the study.
•9. Pregnant women or women anticipating pregnancy.

发起方

Dr K Sireesha