Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Neem extract 125 mg: Given twice daily in the morning and in the evening. Will be used as add on therapy to the existing treatment with metformin.
Intervention2: Neem extract 250 mg: G
Sponsors
Dr G Srinivas
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects between 30-65 years and willing to give informed consent and comply with protocol related study procedures. 2. Fasting plasma glucose of 110-126 mg/dL. 3. Glycosylated haemoglobin (HbA1c) between 6.5 % and 8%. 4. Patients on stable dose of anti-diabetic treatment (metformin 1500-2500 mg/day) for the past 8 weeks prior to the screening. 5. Patients with endothelial dysfunction ââ?¬â?? (salbutamol challenge test) documented as decrease in RI index by 6. Subjects not on any investigational products in the past 6 months.
Exclusion criteria
Exclusion criteria: 1. Subjects with abnormal hematological or biochemical parameters considered significant by investigator. 2. Uncontrolled diabetes(HbA1c > 8% and FBS > 210 mg/dl). 3. Uncontrolled hypertension ( SBP >180mmHg and DBP >100mmHg). 4. Serum Triglycerides >500mg/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. Any medical condition where physician feels participation in the study could be detrimental to subjects well being.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Reduction in HbA1c by at least 1% with 12 weeks therapy. 2.Reduction in FBS and PPBS by at least 10mg/dl. Timepoint: Baseline to 12 weeks of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in endothelial dysfunction as assessed by more than 6% change in reflection index in all the treatment groups. 2.Change in endothelial function biomarkers, nitric oxide (NO), glutathione (GSH), Malondialdehyde (MDA), high sensitivity C-reactive protein (hsCRP), platelet aggregation and lipid profile from in all the treatment groups. 3. Change in HOMA-IR and proinflammatory cytokines- IL6, TNF alpha 4.Safety and tolerability assessment of the test medications. Timepoint: Baseline to 12 weeks of therapy | — |
Countries
India
Contacts
Public ContactDr P Usharani
Nizams Institute of Medical Sciences
Outcome results
None listed