Health Condition 1: null- Type 2 diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.patients with fasting plasma glucose levels of 110-126 mg/dL 2.glycosylated haemoglobin (HbA1c) between 6.5 % and 8% 3. taking stable dose of anti-diabetic treatment (metformin 1500-2000 mg/day) for the past 8 weeks prior to the screening visit 4. those who have endothelial dysfunction defined as <= 6% change in reflection index (RI) on post salbutamol challenge test
Exclusion criteria
Exclusion criteria: Patients with severe uncontrolled hyperglyceamia, uncontrolled hypertension, cardiac arrhythmia, impaired hepatic or renal function, history of malignancy or stroke, smoking, chronic alcoholism, any other serious disease requiring active treatment and treatment with any other herbal supplements, were excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in endothelial dysfunction as assessed by more than 6% change in reflection index at 12 weeks in all the treatment groups.Timepoint: at the end of 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| change in glycosylated hemoglobin (HbA1c) and lipid profileTimepoint: at 12 weeks;change in oxidative stress markers glutathione (GSH), malondialdehyde (MDA), serum levels of nitric oxide (NO), high-sensitivity C-Reactive Protein (hsCRP)Timepoint: at 12 weeks | — |
Countries
India
Contacts
Nizams Institute of Medical Sciences