Health Condition 1: E785- Hyperlipidemia, unspecified
Conditions
Interventions
Intervention1: Rosuvastatin and Zinc: Rosuvastatin10 mg and Zinc 25 mg OD orally for 12 weeks
Control Intervention1: Rosuvastatin: Rosuvastatin 10mg oral tablet OD for 12 weeks
Sponsors
Mahima Singh
Eligibility
Inclusion criteria
Inclusion criteria: Patients having serum LDL cholesterol above 130mg/dl, Serum triglycerides above or equal to 150mg/dl and less than or equal to 500mg/dl. Patients who are able to adequately maintain diary. Patients who are able and are willing to comply with the protocol and have signed IEC or IRB approved ICF
Exclusion criteria
Exclusion criteria: Fasting serum triglyceride (TG) level above 500 mg/dl, Medical history of systemic infection within 6 weeks of study initiation, Medical history of unstable angina, myocardial infarction, heart failure or stroke within 3 months of the study, Uncontrolled hypertension (systolic blood pressure above 160 mm Hg and/or diastolic blood pressure above 100 mm Hg), Uncontrolled diabetes mellitus (FBS above 300 mg/dl in patients with diabetes), ALT and AST greater than 2x upper limit of normal, Impaired renal function (creatinine greater than or equal to 2.0 mg/dl), Suffering from malabsorption syndrome or inflammatory bowel disease, Pregnancy/Lactation, Alcoholism, Patients on drugs that can increase the incidence of statin induced myopathy, Patient on chronic anti-inflammatory or antioxidant drugs within 6 weeks of study initiation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy in achieving target LDL-C and triglyceride levelsTimepoint: 6 and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To establish the patient characteristics based upon baseline data with dyslipidemia in Kanpur, UP population Incidence of any adverse drug reaction will be reported at Timepoints-every 2 week for12 weeks Changes Serum HDL-c levels at Timepoints-every 2 week for12 weeks Patient compliance Timepoint: Baseline, 6 and 12 weeks | — |
Countries
India
Contacts
Public ContactMahima Singh
RAMA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER
Outcome results
None listed