Study to evaluate Efficacy and Safety of PreLipid® on subjects with higher than normal blood lipid levels
A Prospective, Double Blind, Placebo-Controlled, Randomized, Multicentric, study to evaluate the safety, efficacy and tolerability of PreLipid®, a twice-daily nutritional supplement in subjects with higher than normal blood lipid levels
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
180
Study Dietary Supplement (PreLipid 600 mg capsules) will be given to subjects twice daily 30 mins before food for 90 days along with lifestyle modification.
Life Care Institute of Medical Science & Research
Ahmedabad, Gujarat, India
Bhatia Hospital Medical Research Society
Mumbai, Maharashtra, India
Dr. Vikas Govind Pai Clinical Research Foundation
Pune, Maharashtra, India
Division of Clinical & Preventive Cardiology, Heart Institute
Efficacy of Dietary Supplement PreLipid 600 mg twice-daily in lowering LDL-C levels
Change in LDL-C % from baseline (Day 1) to the end of supplementation/treatment after 90 days
Time frame: Day 1 (Baseline) to Day 90 (End of Study)
Safety of Dietary Supplement PreLipid 600 mg twice-daily
Measure changes in Liver Function Tests: Aspartate Aminotransferase (AST) from baseline (Day 1) to End of Study (Day 90); Alanine Aminotransferase (ALT) from baseline (Day 1) to End of Study (Day 90) and Alkaline Phosphatase (ALP) from baseline (Day 1) to End of Study (Day 90)
Time frame: Day 1(Baseline) to Day 90 (End of Study)
Changes in Glycemic Status
To assess percentage changes in Blood Sugar profile (HbA1c) from baseline to at the end of supplementation after 03 months.
Time frame: Day 1 (Baseline) to Day 90 (End of Study)
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Gurgaon, National Capital Territory of Delhi, India
Fortis Escorts Hospital
Jaipur, Rajasthan, India
Pace Clinical Research Center
Bangalore, Tamil Nadu, India
Singvi Health Centre
Chennai, Tamil Nadu, India
Rangammal Hospital
Tiruvannamalai, Tamil Nadu, India