None listed
Conditions
Interventions
Intervention1: KaraHeart (500mg): Synergistic composition of herbal extracts
Control Intervention1: Placebo (500mg): Inert product with no health effect
Sponsors
GreenChem
KARALLIEF INC
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult men and women subjects between the age groups of 20ââ?¬â??60 years with the confirmed case of mild to moderate hyperlipidemia. 2.As per ATP III guidelines; baseline LDL ranging >100 mg/dL, TC >200 mg/dL, TGL ranging 150-199 mg/dL, VLDL-Cholesterol >40 mg/dL, HDL-cholesterol: Men- 3.Subjects having all or at least any one of the diagnostic criteria mentioned above will be selected for the study. 4.Subjects with low BMI but abnormal lipid profile. 5.Subjects who are able to understand the risks/benefits of the protocol and are willing to give written informed consent.
Exclusion criteria
Exclusion criteria: 1.Subjects on concurrent lipid-lowering medications like statins, or fibrates, or dietary supplements within 30 days prior to screening. 2.Subjects suffering from Hyperlipidemia due to Consumption of drugs such as glucocorticoids. 3.Subjects with chronic diseases requiring continuous use of vasoactive,diuretics or lipid-lowering drugs. 4.Subjects suffered from intractable obesity, had defined weight limits or had experienced any recent, unexplained weight loss or gain. 5.Subjects having history of any major illness of cardiovascular diseases eg.Angina pectoris, myocardial infarction etc. 6.Subjects having a history of thyroid disorder (TSH- levels of 10�µg/dL), renal disorder, cholelithiasis or polycystic ovary syndrome (PCOS). 7.Subjects having history of diabetes (Type I or Type II) except other than the subject having the pre-diabetes condition with the fasting blood glucose between 100 to 125 mg/dl or random blood glucose 140-199 mg/dl. 8.Subjects having abnormal liver or kidney function test (ALT or AST) 2 times the upper limit of normal; elevated creatinine (male 125 �¼mol/L, female 110 �¼mol/L).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from the baseline to the end of the treatment period in the levels of total cholesterol,High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Very Low Density Lipoprotein (VLDL)and Triglyceride (TGL)Timepoint: Day 0, Day 30, Day 60, Day 90, Day 120 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from the baseline to the end of the treatment period in the level of Ankle Brachial reflexTimepoint: Day 0 and Day 120;Change from the baseline to the end of the treatment period in the level of C-Reactive ProteinTimepoint: Day 0 and Day120;Change from the baseline to the end of the treatment period in the level of HbA1CTimepoint: Day 0 and Day 120;Change from the baseline to the end of the treatment period in the level of Lipid peroxidationTimepoint: Day 0 and Day 120;Change from the baseline to the end of the treatment period in the level of Serum Apolipoprotein A1Timepoint: Day 0 and Day 120;Change from the baseline to the end of the treatment period in the level of Serum Apolipoprotein BTimepoint: Day 0 and Day 120;Change from the baseline to the end of the treatment period in the level of Total Cholesterol Vs HDL CholesterolTimepoint: Day 0, Day 30, Day 60, Day 90, Day 120 | — |
Countries
India
Contacts
Public ContactMr Dheeraj Kumar Deep
GreenChem
Outcome results
None listed