Health Condition 1: null- Type 2 diabetes mellitus patients Health Condition 2: E119- Type 2 diabetes mellitus without complications
Conditions
Sponsors
Nizams Institute of Medical Sciences
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 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. Change in endothelial dysfunction as assessed by more than 6% change in reflection index at 12 weeks in all the treatment groups.Timepoint: 0, 4, 8, 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in biomarkers from baseline to end of 12 weeks therapy in all the treatment groups.Timepoint: 0, 4, 8, 12 weeks | — |
Countries
India
Contacts
Public ContactDr P Usharani
Nizams Institute of Medical Sciences
Outcome results
None listed