Health Condition 1: E889- Metabolic disorder, unspecified
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.
Intervention2: Neem extract 250 mg: Given twice daily
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.Subjects having endothelial dysfunction defined as ââ?°Â¤ 6% change in reflection index (RI) on post salbutamol challenge test. 3. Subjects who comply with ââ?¬Å?The International Diabetes Federationââ?¬? guidelines dated 2006. 4. 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 hypertension (SBP >180mmHg and DBP >100mmHg). 3. Serum Triglycerides >500mg/dl. 4. AST and ALT elevation >3 times upper limit of normal. 5. Serum creatinine more than 1.5 mg/dl. 6. On any other dietary or herbal supplements. 7. History of malignancy or stroke. 8. Smoking, chronic alcoholism. 9. Any medical condition where physician feels participation in the study could be detrimental to subjects well-being.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in lipid profile with 12 weeks therapy. 2.Reduction in FBS 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 2. Change in endothelial function biomarkers, nitric oxide (NO), glutathione (GSH), Malondialdehyde (MDA), high sensitivity C-reactive protein(hsCRP), HbA1c, platelet aggregation and lipid profile 3. To evaluate change inHOMA-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