A study to evaluate cholesterol lowering effect of Vitamin C as an add on therapy in diabetic patients
Phase 4
Completed
- Conditions
- Health Condition 1: null- Uncontrolled diabetes mellitus
- Registration Number
- CTRI/2017/10/010035
- Lead Sponsor
- School of pharmaceutical sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 64
Inclusion Criteria
patients diagnosed with type 2 diabetes mellitus for a period of not less than 2 years with co-morbid cardiovascular disease (new onset/past history), whose blood sugar profile is uncontrolled as indicated by HbA1c above 8.0, in treatment with the standard treatment regimen for diabetes mellitus as per the recommended guidelines and willing to provide written informed consent.
Exclusion Criteria
1.Patients with concomitant life threatening illness, including myocardial infarction, ischemic stroke or risk of developing NSTEMI, STEMI.
2.Patients with metabolic acidosis
3.Patients who had a history of renal calculi
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of effet of Vitamin C Adjuant therapy significance on lipid profile and HbA1c in diabetes patients with co-morbid cardiovascular disease.Timepoint: Baseline, 1st month, 2nd month and 3rd month.
- Secondary Outcome Measures
Name Time Method Adjustment for factors those confounds the effect of vitamin therapy on lipid profile and thereby quantify the extent of the effectTimepoint: Baseline, 1st month, 2nd month and 3rd month.;Assessement of the acute effect of Vitamin C adjuant therapy on serum C-reactive protein.Timepoint: Baseline, 1st month, 2nd month and 3rd month.;Evaluation of Incidence of elevated CRP levels in diabetic patients with dislipidemiaTimepoint: Baseline, 1st month, 2nd month and 3rd month.