
Evaluation Series on Safety and Efficacy of Nutritional Supplements
Evaluation | Visit 01/ Baseline | Visit 02/ Randomization Day 02 + 02 days | Visit 03/Week 04± 04 days | Visit 04/ ET Week 12± 04 days |
Inclusion/Exclusion Criteria | x | x | ||
Informed consent | x | |||
Demographic Details | x | |||
Clinical Evaluation/ Physical Examination and Vital sign |
x | x | x | x |
Electrocardiogram | x | x | ||
Laboratory Assessment | x | x | x | |
IP Dispensing | x | x | ||
IP Accountability | x | x | ||
Compliance Assessment | x | x | ||
Concomitant medication | x | x | x | x |
Life style modification program | x | x | x | x |
Parameter | Visit 1/ screening | Visit 03/ Week 4 | Visit 04/Week 12 |
Serum Fasting LDL-Cholesterol(mg/dl) | x | x | x |
Serum Fasting Total-Cholesterol(mg/dl) | x | x | x |
Serum Triglyceride (mg/dl) | x | x | |
HbA1c | x | x | |
Fasting Plasma Glucose (FPG ) | x | x | x |
SGOT (AST) | x | x | |
SGPT (ALT) | x | x | |
S. Alkaline Phosphatase | x | x | |
Total Bilirubin | x | x | |
Blood Urea Nitrogen (BUN) | x | x | |
SerumCreatinine | x | x | |
Hematology/CBC | x | x | |
Urine analysis | x | x |
*Subjects should be in fasting condition for at least 08-10 hours, without having any food and medication during above mentioned visits. Drinking water during fasting is acceptable.