Prevention and management of diabetic complications by an Ayurvedic formulatio
Phase 3
- Conditions
- Health Condition 1: null- Type-2 Diabetes mellitus
- Registration Number
- CTRI/2015/01/005366
- Lead Sponsor
- SRM University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 1000
Inclusion Criteria
1.Patients of type-2 diabetes mellitus
2. Fasting blood glucose level <225mg/dl
3. Postprandial blood glucose level <350mg/dl
Elevated pro-inflammatory markers like TNF-alpha, IL-6, hs.CRP, Resistin, low concentration of adiponectin
Exclusion Criteria
Patients of type-1 diabetes mellitus
Age <35 years and >65 years
Fasting Blood glucose level >225mg/dl
Postprandial blood glucose level >350mg/dl
Patients suffering from chronic illness like T.B., Rheumatoid arthritis, diagnosed CHD cases.
Pregnant and lactating women
Sudden deterioration in patients health during the period of study
Non compliance of the patient
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The test formulation prevents the development of nephropathy, neuropathy and retinopathy among diabetic patients. It has beneficial role in the management of diabetic microvascular complications.Timepoint: Parameters measured at baseline (initial), 3 months, 6 months and 12 months. The blood glucose level was estimated at the end of every month upto 12 months
- Secondary Outcome Measures
Name Time Method The test formulation prevents the onset of adverse coronary event among diabetic patientsTimepoint: Parameters measured at baseline (initial), 3 months, 6 months and 12 months. The blood glucose level was estimated at the end of every month upto 12 months