Health Condition 1: E119- Type 2 diabetes mellitus without complications Health Condition 2: null- Type II Diabetes Mellitus
Conditions
Interventions
Intervention1: Emblica officinalis: One capsule of Emblica officinalis twice daily for 12 weeks.
Control Intervention1: Placebo: one capsule of Placebo twice daily for 12 weeks.
Sponsors
Dr Ramakanth
Eligibility
Inclusion criteria
Inclusion criteria: Patients of either gender aged 30 to 68 years Fasting plasma glucose of greater than or equal to 110 milligram per decilitre A glycosylated haemoglobin (HbA1c) between 7 and 9 percent Taking stable dose of antidiabetic treatment Glimiperide 1 to 4 milligram per day for the past 8 weeks prior to the screening visit and having endothelial dysfunction defined as less than or equal to 6 percent change in reflection index 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in endothelial dysfunction as assessed by more than 6percent change in Reflection index at 12 weeks in both the treatment groups.Timepoint: Baseline 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in oxidative stress markers Change in serum levels of nitric oxide Change in lipid profile Change in glycosylated haemoglobin A1c Change in platelet aggregation test Laboratory safety assessmentsTimepoint: Week 12 | — |
Countries
India
Contacts
Public ContactDr Ramakanth
Nizams Institute of Medical Sciences
Outcome results
None listed