Health Condition 1: null- Patients with higher LDL-C (Low Density Lipoprotein- Cholestrol)then normal value
Conditions
Interventions
Intervention1: Capsule Prelipid: Powder filled capsule equivalent to 500 mg active ingradient
Dose: 01 capsule BID- before breakfast and 01 capsule before dinner.
Route of Adminstration: Oral,
Dur
Sponsors
Preemptive Meds Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Newly diagnosed Male or Female participants with higher than normal cholesterol levels defined by the American Heart Association, National Cholesterol Education Program (NCEP) and ATP-III goals for LDL cholesterol and cut off points for therapeutic lifestyle changes (TLCs) and drug therapy in different risk categories: Age >= 18 years to ï?? LDL cholesterol levels >140mg/dl but ï?? Participants who are on Atorvastatin 10 mg daily treatment with life style modification program for at least last 03 months and have LDL-C i.e >140 mg/dl with 0-2 risk factor ï?? Ability to understand and willingness to sign and date a written Informed Consent Document at the screening visit before any protocol- specific procedures are performed and willing to adhere to the protocol and entire trial procedures
Exclusion criteria
Exclusion criteria: ï?? Stroke, myocardial infarction, coronary artery bypass graft (CABG) percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months. ï?? Cardiac status New York Heart Association class III-IV ï?? Uncotrolled blood pressure 150 mmhg systolic and 100 mmhg diastolic ï?? Impaired renal function as shown by but not limited to serum creatinine >= 1.5 mg/dl for males and >= 1.4 mg/dl for female ï?? Clinically significant peripheral edema ï?? Clinical evidence of active liver disease or serum alenine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5 times the upper limit of the normal range (2.5 X ULN) ï?? Participants on steroid ï?? Pregnancy or lactating women ï?? Known hypersensitivity to any of the study drugs ï?? Any malignancy within the last 5 years, with exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated carcinoma insitu. ï?? Current addiction or current alcohol abuse or history of substance or alcohol abuse within the last 2 years ï?? Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol ï?? Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study. Subject unlikely to comply with protocol e.g. uncooperative attitude, inability to return for follow up visits and unlikelihood completing of the study ï?? Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the study evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the Efficacy and Safety of PreLipid® by â?¢ Measuring reduction % changes of LDL-C from baseline to the end of supplementation after 03 months and, â?¢ Evaluating safety and tolerability by measuring changes in baseline renal function and liver function tests Timepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Percentage of subjects achieving LDL-C 100 mg/dl â?¢ To assess reduction % changes of Triglyceride (TG) levels from baseline to at the end of treatment after 3 months. â?¢ To assess % changes in Blood Sugar profile (HbA1c) from baseline to at the end of supplementation after 03 months. Timepoint: 3 months | — |
Countries
India
Contacts
Public ContactDr Ravi R Kasliwal
Medanta Hospital
Outcome results
None listed