Health Condition 1: R688- Other general symptoms and signs
Conditions
Interventions
Intervention1: 250 mg capsule of neem extract: One 250 mg capsule of neem extract twice daily for a total dose of 500 mg of per day
Intervention2: 500 mg capsule of neem extract: One 500 mg capsule o
Sponsors
Dr K Sireesha
Eligibility
Inclusion criteria
Inclusion criteria: 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. Subjects with endothelial dysfunction – (salbutamol challenge test) documented as decrease in RI index by 7. Subjects not on any investigational products in the past 6 months.
Exclusion criteria
Exclusion criteria: 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Reduction in HbA1c by at least 0.5% with 24 weeks therapy when compared to baseline and placebo. 2.Reduction in FBS by at least 5mg/dL and PPBS by at least 10mg/dL when compared to baseline and placebo. 3.Change in HOMA-IR and C-peptide when compared to baseline and placebo. Timepoint: baseline 4 8 16 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in endothelial dysfunction as assessed by more than 6% change in reflection index at 24 weeks when compared to baseline and placebo. 2. Change in oxidative stress biomarkers - nitric oxide (NO), glutathione (GSH), malondialdehyde (MDA), and inflammatory biomarker - high sensitivity C-reactive protein (hsCRP) and lipid profile compared to baseline and placebo. 3. Safety and tolerability assessment of the study medications as assessed by adverse events and laboratory parameters.Timepoint: baseline 4 8 16 24 weeks | — |
Countries
India
Contacts
Public ContactDr P Usharani
Nizams Institute of Medical Sciences
Outcome results
None listed